A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma
MANDALA
A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma
1 other identifier
interventional
3,132
11 countries
345
Brief Summary
This is a randomized, double-blind, multicenter, parallel-group, variable-length study to compare 2 doses of BDA MDI (PT027) with AS MDI (PT007) on the time to first severe asthma exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Dec 2018
Longer than P75 for phase_3 asthma
345 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2018
CompletedFirst Posted
Study publicly available on registry
December 7, 2018
CompletedStudy Start
First participant enrolled
December 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2022
CompletedResults Posted
Study results publicly available
September 28, 2022
CompletedSeptember 28, 2022
September 1, 2022
2.7 years
November 30, 2018
July 29, 2022
September 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With a Severe Asthma Exacerbation Event
Time to first severe asthma exacerbation will be calculated as the time from randomization until the start date of the first severe asthma exacerbation. An asthma exacerbation will be considered severe if it results in at least one of the following: a temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening (a single depo-injectable dose of corticosteroids will be considered equivalent), an emergency room or urgent care visit (\<24 hours in the facility for evaluation and treatment) due to asthma that required systemic corticosteroids, or an in-patient hospitalization (admission to an in-patient facility and/or ≥ 24 hours in a healthcare facility) due to asthma. The descriptive summary shows the number of participants with a severe exacerbation event, occurring between the date of randomization up to the date of randomized treatment discontinuation or a change in maintenance therapy.
From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
Secondary Outcomes (4)
Annualized Severe Exacerbation Rate
From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
Total Annualized Dose of Systemic Corticosteroid (SCS)
From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.
Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24
From baseline to Week 24
Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24
From baseline to 24 weeks
Study Arms (3)
BDA MDI (PT027) 160/180 μg
EXPERIMENTALBudesonide/albuterol sulfate, BDA MDI, PT027 high dose
BDA MDI (PT027) 80/180 μg
EXPERIMENTALBudesonide/albuterol sulfate, BDA MDI, PT027 low dose
AS MDI (PT007) 180 µg
ACTIVE COMPARATORAlbuterol sulfate MDI, PT007
Interventions
Budesonide/albuterol sulfate combination inhalation aerosol
Budesonide/albuterol sulfate combination inhalation aerosol
Albuterol sulfate inhalation aerosol
Eligibility Criteria
You may qualify if:
- Female or male aged ≥4 years at the time of informed consent
- Physician diagnosis of asthma documented for at least 1 year
- Receiving 1 of the following scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1:
- Medium-to-high-dose inhaled corticosteroid (ICS)
- Medium-to-high-dose ICS and 1 additional maintenance therapy from the following: leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA), or theophylline
- Low-to-high-dose ICS in combination with long-acting β2-adrenoreceptor agonist (LABA) with or without one additional maintenance therapy from the following: LTRA, LAMA, or theophylline
- Prebronchodilator forced expiratory volume in 1 second (FEV1) of ≥40 to \<90% predicted normal value for adults and adolescents, and ≥60 to \<100% predicted normal value for subjects aged 4 to 11 years after withholding specified medications including short/rapid-acting β2-adrenoreceptor agonist (SABA)
- Demonstrate reversibility at Visit 1, with an increase in FEV1 ≥12% (and ≥200 mL for subjects aged ≥18 years) relative to baseline after administration of sponsor provided Ventolin via central spirometry. One re-test for reversibility testing is allowed within the screening period in advance of Visit 2
- Demonstrate acceptable spirometry performance (i.e., meet American Thoracic Society/European Respiratory Society acceptability/repeatability criteria)
- A documented history of at least 1 severe asthma exacerbation within 12 months before Visit 1
- Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator
You may not qualify if:
- Chronic obstructive pulmonary disease or other significant lung disease (e.g., chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
- Oral corticosteroid/SCS use (any dose and any indication) within 6 weeks before Visit 1
- Chronic use of oral corticosteroids (OCS, ≥3 weeks use in 3 months prior to Visit 1)
- Having received any marketed (e.g., omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or any other prohibited medication
- Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months before Visit 1 (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana)
- Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years of Visit 1
- Historical or current evidence of a clinically significant disease
- Cancer not in complete remission for at least 5 years
- Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
- History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
- Significant abuse of alcohol or drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (345)
Research Site
Birmingham, Alabama, 35209, United States
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Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Montgomery, Alabama, 36106, United States
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Scottsboro, Alabama, 35768, United States
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Sheffield, Alabama, 35660, United States
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Tuscumbia, Alabama, 35674, United States
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Glendale, Arizona, 85306, United States
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Peoria, Arizona, 85381, United States
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Scottsdale, Arizona, 85251, United States
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Little Rock, Arkansas, 72209, United States
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Bakersfield, California, 93301, United States
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Bellflower, California, 90706, United States
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Canoga Park, California, 91304, United States
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Encinitas, California, 92024, United States
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Hawthorne, California, 90250, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90025, United States
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Los Angeles, California, 90048, United States
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Newport Beach, California, 92663, United States
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Rancho Cucamonga, California, 91730, United States
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Redwood City, California, 94063, United States
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Sacramento, California, 95823, United States
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San Diego, California, 92120, United States
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San Francisco, California, 94102, United States
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San Jose, California, 95117, United States
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Westminster, California, 92683, United States
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Aurora, Colorado, 80045, United States
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Colorado Springs, Colorado, 80907, United States
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Colorado Springs, Colorado, 80909, United States
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Denver, Colorado, 80206, United States
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Denver, Colorado, 80230, United States
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Denver, Colorado, 80246, United States
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Waterbury, Connecticut, 06708, United States
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Aventura, Florida, 33180, United States
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Boynton Beach, Florida, 33436, United States
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Cape Coral, Florida, 33991, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33765, United States
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DeLand, Florida, 32720, United States
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Gainesville, Florida, 32653, United States
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Greenacres City, Florida, 33467, United States
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Hialeah, Florida, 33012, United States
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Kissimmee, Florida, 34741, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33173, United States
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Miami, Florida, 33174, United States
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Miami, Florida, 33175, United States
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Miami, Florida, 33186, United States
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Orlando, Florida, 32806, United States
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Orlando, Florida, 32819, United States
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Oviedo, Florida, 32765, United States
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Palmetto Bay, Florida, 33157, United States
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Panama City, Florida, 32405, United States
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Pembroke Pines, Florida, 33024, United States
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Pembroke Pines, Florida, 33026, United States
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St. Petersburg, Florida, 33707, United States
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St. Petersburg, Florida, 33710, United States
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Albany, Georgia, 31707, United States
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Winder, Georgia, 30680, United States
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Meridian, Idaho, 83646, United States
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Chicago, Illinois, 60644, United States
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Normal, Illinois, 61761, United States
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Iowa City, Iowa, 52242, United States
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Overland Park, Kansas, 66210, United States
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Topeka, Kansas, 66606, United States
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Owensboro, Kentucky, 42301, United States
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Bangor, Maine, 04401, United States
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Baltimore, Maryland, 21209, United States
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Chevy Chase, Maryland, 20815, United States
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White Marsh, Maryland, 21162, United States
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Boston, Massachusetts, 02115, United States
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Fall River, Massachusetts, 02723, United States
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North Dartmouth, Massachusetts, 02747, United States
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Ann Arbor, Michigan, 48106, United States
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Ann Arbor, Michigan, 48109, United States
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Farmington Hills, Michigan, 48336, United States
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Flint, Michigan, 48504, United States
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Flint, Michigan, 48507, United States
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Hamtramck, Michigan, 48212, United States
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Rochester, Michigan, 48307, United States
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Rochester Hills, Michigan, 48307, United States
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Ypsilanti, Michigan, 48197, United States
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Hazelwood, Missouri, 63042, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63141, United States
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Bellevue, Nebraska, 68005, United States
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Bellevue, Nebraska, 68123, United States
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Lincoln, Nebraska, 68505, United States
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Las Vegas, Nevada, 89106, United States
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Brick, New Jersey, 08724, United States
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Marlton, New Jersey, 08053, United States
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New Brunswick, New Jersey, 08901, United States
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Toms River, New Jersey, 08755, United States
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Albuquerque, New Mexico, 87131, United States
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Brooklyn, New York, 11230, United States
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New Hyde Park, New York, 11040, United States
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Potsdam, New York, 13676, United States
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The Bronx, New York, 10461, United States
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Asheville, North Carolina, 28801, United States
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Charlotte, North Carolina, 28207, United States
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Charlotte, North Carolina, 28210, United States
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Charlotte, North Carolina, 28277, United States
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Gastonia, North Carolina, 28054, United States
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High Point, North Carolina, 27262, United States
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Monroe, North Carolina, 28112, United States
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Raleigh, North Carolina, 27607, United States
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Winston-Salem, North Carolina, 27104, United States
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Fargo, North Dakota, 58104, United States
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Cincinnati, Ohio, 45231, United States
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Cincinnati, Ohio, 45242, United States
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Columbus, Ohio, 43207, United States
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Dayton, Ohio, 45406, United States
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Dayton, Ohio, 45459, United States
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Dublin, Ohio, 43016, United States
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Mayfield Heights, Ohio, 44124, United States
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Edmond, Oklahoma, 73034, United States
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Oklahoma City, Oklahoma, 73112, United States
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Tulsa, Oklahoma, 74136, United States
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Medford, Oregon, 97504, United States
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Blue Bell, Pennsylvania, 19422, United States
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Erie, Pennsylvania, 16508, United States
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Philadelphia, Pennsylvania, 19140, United States
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Pittsburgh, Pennsylvania, 15241, United States
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East Providence, Rhode Island, 02914, United States
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Providence, Rhode Island, 02908, United States
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Warwick, Rhode Island, 02886, United States
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Anderson, South Carolina, 29621, United States
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Clinton, South Carolina, 29325, United States
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Columbia, South Carolina, 29203, United States
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Gaffney, South Carolina, 29341, United States
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Greenville, South Carolina, 29607, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Myrtle Beach, South Carolina, 29588, United States
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North Charleston, South Carolina, 29420, United States
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Pelzer, South Carolina, 29669, United States
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Rock Hill, South Carolina, 29732, United States
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Spartanburg, South Carolina, 29303, United States
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Austin, Texas, 78726, United States
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Austin, Texas, 78759, United States
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Beaumont, Texas, 77702, United States
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Boerne, Texas, 78006, United States
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Conroe, Texas, 77384, United States
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Corsicana, Texas, 75110, United States
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Dallas, Texas, 75225, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75246, United States
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El Paso, Texas, 79903, United States
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Galveston, Texas, 77555, United States
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Houston, Texas, 77036, United States
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Kerrville, Texas, 78028, United States
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Live Oak, Texas, 78233, United States
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McKinney, Texas, 75069, United States
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Pearland, Texas, 77584, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78230, United States
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Sherman, Texas, 75092, United States
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The Woodlands, Texas, 77380, United States
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Tomball, Texas, 77375, United States
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Waco, Texas, 76712, United States
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Waxahachie, Texas, 75165, United States
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Murray, Utah, 84107, United States
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Salt Lake City, Utah, 84107, United States
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South Burlington, Vermont, 05403, United States
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Morgantown, West Virginia, 26505, United States
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Greenfield, Wisconsin, 53228, United States
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Buenos Aires, C1121ABE, Argentina
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Buenos Aires, C1128AAF, Argentina
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Buenos Aires, C1414AJF, Argentina
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Buenos Aires, C1424CSF, Argentina
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Buenos Aires, C1425BEN, Argentina
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Buenos Aires, C1425FVH, Argentina
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Córdoba, X5003DCE, Argentina
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Lanús, B1824KAJ, Argentina
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Mar del Plata, B7602DCK, Argentina
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Mendoza, 5500, Argentina
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Mendoza, M5500GPD, Argentina
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Quilmes, 1878, Argentina
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Rosario, S2000DBS, Argentina
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Rosario, S2000DEJ, Argentina
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Rosario, S2000JKG, Argentina
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Salta, A4400, Argentina
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San Fernando, B1646EBJ, Argentina
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San Juan Bautista, CP188, Argentina
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San Miguel de Tucumán, T4000CBC, Argentina
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San Miguel de Tucumán, T4000IAQ, Argentina
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San Miguel de Tucumán, T4000, Argentina
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Santa Fe, 2000, Argentina
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Santa Fe, S3000ASF, Argentina
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Vancouver, British Columbia, V5Z 4E1, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Greater Sudbury, Ontario, P3A 1W8, Canada
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London, Ontario, N5W 6A2, Canada
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Newmarket, Ontario, L3Y5G8, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Waterloo, Ontario, N2J 1C4, Canada
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Windsor, Ontario, N8X 1T3, Canada
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Québec, Quebec, C1G 3Y8, Canada
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Beroun, Czechia
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Brandýs nad Labem, Czechia
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Jindřichův Hradec, Czechia
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Kralupy nad Vltavou, Czechia
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Kuřim, Czechia
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Lovosice, Czechia
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Miroslav, Czechia
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Neratovice, Czechia
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Prague, 110 00, Czechia
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Prague, 14 800, Czechia
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Rokycany, Czechia
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Tábor, Czechia
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Teplice, Czechia
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Varnsdorf, Czechia
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Augsburg, Germany
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Bad Wörishofen, Germany
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Bamberg, Germany
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Bergisch Gladbach, Germany
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Berlin, 10119, Germany
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Berlin, 10367, Germany
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Berlin, 10627, Germany
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Berlin, 10717, Germany
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Berlin, 10787, Germany
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Berlin, 12157, Germany
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Berlin, 12159, Germany
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Berlin, 12203, Germany
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Berlin, 13187, Germany
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Bonn, Germany
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Cologne, Germany
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Cottbus, Germany
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Darmstadt, Germany
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Delitzsch, Germany
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Dortmund, Germany
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Essen, Germany
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Frankfurt, 60389, Germany
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Frankfurt, 60596, Germany
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Geesthacht, Germany
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Gelsenkirchen, Germany
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Halle, Germany
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Hamburg, 20354, Germany
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Hamburg, 22299, Germany
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Hanover, 30167, Germany
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Hanover, 30173, Germany
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Homburg, Germany
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Jena, Germany
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Leipzig, 04107, Germany
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Leipzig, 04157, Germany
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Leipzig, 04207, Germany
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Leipzig, 04275, Germany
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Leipzig, 04357, Germany
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Lübeck, 23552, Germany
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Lübeck, 23558, Germany
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Magdeburg, Germany
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Marburg, Germany
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München, 80809, Germany
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München, 81241, Germany
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Neu-Isenburg, Germany
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Peine, Germany
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Potsdam, Germany
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Radebeul, Germany
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Reinfeld, Germany
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Rosenheim, Germany
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Schleswig, Germany
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Wiesbaden, Germany
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Witten, Germany
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Belgrade, 11000, Serbia
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Kamenitz, 21204, Serbia
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Kragujevac, Serbia
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Niš, Serbia
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Valjevo, Serbia
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Bratislava, Slovakia
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Ilava, Slovakia
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Kežmarok, Slovakia
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Košice, 040 01, Slovakia
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Košice, 040 22, Slovakia
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Poprad, Slovakia
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Prešov, Slovakia
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Žilina, Slovakia
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Athlone, South Africa
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Bellville, South Africa
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Benoni, South Africa
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Bloemfontein, South Africa
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Boksburg, South Africa
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Cape Town, 7500, South Africa
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Cape Town, 7505, South Africa
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Durban, 4001, South Africa
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Durban, 4091, South Africa
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eMkhomazi, South Africa
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Gatesville, South Africa
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Johannesburg, South Africa
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Kempton Park, South Africa
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Kraaifontein, South Africa
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Middelburg, South Africa
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Mowbray, 7700, South Africa
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Newtown, South Africa
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Parktown, South Africa
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Pretoria, 0002, South Africa
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Pretoria, 0183, South Africa
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Roodepoort, South Africa
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Umhlanga, South Africa
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Witbank, South Africa
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Barcelona, 08006, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 08916, Spain
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Girona, Spain
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Madrid, Spain
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Mérida, Spain
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Valencia, Spain
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Cherkasy, Ukraine
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Dnipro, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, 61002, Ukraine
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Kharkiv, 61039, Ukraine
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Kharkiv, 61124, Ukraine
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Kherson, Ukraine
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Kyiv, 02232, Ukraine
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Kyiv, 03680, Ukraine
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Kyiv, 04201, Ukraine
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Lutsk, Ukraine
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Uzhhorod, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, 69035, Ukraine
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Zaporizhzhya, 69118, Ukraine
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Zaporizhzhya, 69600, Ukraine
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Belfast, United Kingdom
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Blackpool, United Kingdom
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Bradford, United Kingdom
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Chippenham, United Kingdom
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Corby, NN17 2UR, United Kingdom
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Corby, NN18 9EZ, United Kingdom
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Kenilworth, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Northwood, United Kingdom
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Nottingham, United Kingdom
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Peterborough, United Kingdom
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Romford, United Kingdom
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Shipley, United Kingdom
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Sidcup, United Kingdom
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Wokingham, United Kingdom
Related Publications (4)
Chipps BE, Albers FC, Reilly L, Johnsson E, Cappelletti C, Papi A. Efficacy and safety of as-needed albuterol/budesonide versus albuterol in adults and children aged >/=4 years with moderate-to-severe asthma: rationale and design of the randomised, double-blind, active-controlled MANDALA study. BMJ Open Respir Res. 2021 Dec;8(1):e001077. doi: 10.1136/bmjresp-2021-001077.
PMID: 34887317BACKGROUNDPapi A, Chipps BE, Beasley R, Panettieri RA Jr, Israel E, Cooper M, Dunsire L, Jeynes-Ellis A, Johnsson E, Rees R, Cappelletti C, Albers FC. Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med. 2022 Jun 2;386(22):2071-2083. doi: 10.1056/NEJMoa2203163. Epub 2022 May 15.
PMID: 35569035RESULTChipps BE, Panettieri RA Jr, Skolnik N, Cappelletti C, Daoud SZ, Dunsire L, Gilbert IA, Papi A. Albuterol-budesonide rescue inhaler for asthma: Patterns of use and safety in the MANDALA trial. Ann Allergy Asthma Immunol. 2026 Jan;136(1):54-60.e3. doi: 10.1016/j.anai.2025.07.008. Epub 2025 Jul 13.
PMID: 40664332DERIVEDKew KM, Flemyng E, Quon BS, Leung C. Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and children. Cochrane Database Syst Rev. 2022 Sep 26;9(9):CD007524. doi: 10.1002/14651858.CD007524.pub5.
PMID: 36161875DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Avillion LLP
Study Officials
- STUDY DIRECTOR
Frank Albers, MD, PhD
Avillion LLP
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2018
First Posted
December 7, 2018
Study Start
December 13, 2018
Primary Completion
August 19, 2021
Study Completion
February 7, 2022
Last Updated
September 28, 2022
Results First Posted
September 28, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share