A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma
DENALI
A 12-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT008 and PT007 Administered QID in Adults and Children 4 Years of Age or Older With Asthma
2 other identifiers
interventional
1,001
7 countries
129
Brief Summary
This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study to compare 2 dose levels of budesonide/albuterol BDA MDI (PT027) to its components budesonide BD MDI (PT008) and albuterol AS MDI (PT007) on improvement in lung function and asthma symptoms after 12 weeks of treatment in adult, adolescent, and child subjects with symptomatic asthma currently being treated with a short/rapid-acting β2-adrenoreceptor agonist (SABA) as needed alone or with low-dose inhaled corticosteroid (ICS) maintenance therapy plus SABA as needed.
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 Mar 2019
Typical duration for phase_3 asthma
129 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedStudy Start
First participant enrolled
March 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2021
CompletedResults Posted
Study results publicly available
September 30, 2022
CompletedApril 13, 2023
April 1, 2023
2.3 years
February 14, 2019
July 19, 2022
April 11, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Concentration Curve From 0 to 6 Hours (AUC0-6 Hours) Over 12 Weeks
Lung function will be measured by spirometry. Baseline FEV1 will be taken as the average of the 60- and 30-minute pre-dose spirometry measures on or before randomization. Starting with the first study drug dose at Week 0 and then at Week 12, spirometry assessments will be completed at 60 and 30 minutes before the morning dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes after dosing. FEV1 AUC0-6 hours will be calculated for changes from baseline (randomization visit) using the trapezoidal rule and will be normalized by dividing by the time (in hours) from dosing to the last measurement included (typically 6 hours).
Baseline and 12 weeks
Change From Baseline in Trough FEV1
Trough FEV1 is calculated at each clinic visit as the average of the 30- and 60-minute pre-dose FEV1 measurements. Baseline FEV1 is defined as the average of the 30- and 60-minute pre-dose measures collected on the day of randomization.
Baseline and 12 weeks
Secondary Outcomes (4)
Time to 15% Increase in FEV1 Over the Pre-treatment Value on Day 1
From first dose (first inhalation of randomized treatment) up to about 40 minutes post-dose (Day 1).
Duration of 15% Increase in FEV1 Over the Pre-treatment Value on Day 1
Onset up to about 40 minutes post-treatment, with duration lasting up to the last assessment of a nominal 6 hour serial spirometry profile (Day 1).
Number of Participants With a Clinically Meaningful Difference on the Asthma Control Questionnaire 7-item Version (ACQ-7) at Week 12.
Baseline and 12 weeks
Change From Baseline in Trough FEV1 at Week 1.
Baseline and 1 week
Study Arms (5)
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
BD MDI (PT008) 160 µg
ACTIVE COMPARATORBudesonide BD MDI (PT008)
AS MDI (PT007) 180 µg
ACTIVE COMPARATORAlbuterol sulfate AS MDI (PT007)
Placebo MDI
PLACEBO COMPARATORPlacebo MDI
Interventions
Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)
Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)
Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)
Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)
Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)
Eligibility Criteria
You may qualify if:
- Female or male aged ≥4 years at the time of informed consent
- Physician diagnosis of asthma with a documented history of the last 6 months
- Receiving 1 of the following inhaled asthma medications with stable dosing for at least 30 days prior to Visit 1:
- Only short/rapid-acting β2-adrenoreceptor agonist (SABA) used as needed
- Stable low-dose inhaled corticosteroid in addition to as-needed use of SABA
- Pre-bronchodilator FEV1 of ≥50 to \<85% predicted normal value for adults (≥18 years of age) and ≥50% predicted normal value for subjects aged 4 to 17 years after withholding SABA ≥6 hours at Visit 1.
- Demonstrate reversibility of airflow limitation defined as a ≥15% increase in FEV1 relative to baseline after administration of Sponsor-provided SABA (Ventolin) at either Visit 1 or Visit 1a.
- Demonstrate acceptable spirometry performance acceptability/repeatability criteria
- Taken Ventolin on ≥2 days out of 7 days prior to Visit 2
- Demonstrate acceptable metered dose inhaler (MDI) administration technique as assessed by the investigator.
- Able to perform acceptable and reproducible peak expiratory flow measurements as assessed by the investigator
You may not qualify if:
- Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
- Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1
- Chronic (≥3 weeks) use of SCS within 6 months prior to Visit 1
- Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, 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 admission to an intensive care unit, intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1
- Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1
- Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1
- Hospitalizations due to asthma within 6 months prior to Visit 1
- Have taken ≥12 actuations per day of Sponsor-provided Ventolin during the run-in period prior to Visit 2 according to the below criteria:
- ≥2 days out of 14 days of run-in
- ≥3 days out of 15 to 21 days of run-in
- ≥4 days out of 22 or more days of run-in
- Unable to comply with study procedures including non-compliance with diary completion (ie, \<70% subject completion of diary assessments in the last 7 days preceding Visit 2 or 4-times daily dosing, \<80% compliance during the placebo run-in period).
- Historical or current evidence of a clinically significant disease
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (129)
Research Site
Mobile, Alabama, 36608, United States
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Bakersfield, California, 93301, United States
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Costa Mesa, California, 92627, United States
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Encinitas, California, 92024, United States
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Huntington Beach, California, 92647, United States
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Lancaster, California, 93534, United States
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Los Angeles, California, 90017, 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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Roseville, California, 95661, United States
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Sacramento, California, 95823, United States
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San Diego, California, 92123, United States
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San Jose, California, 95117, United States
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Waterbury, Connecticut, 06708, United States
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Aventura, Florida, 33180, United States
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Clearwater, Florida, 33765, 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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Miami, Florida, 33126, 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, 33186, 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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Pembroke Pines, Florida, 33024, United States
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Pembroke Pines, Florida, 33026, United States
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Meridian, Idaho, 83646, United States
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Chicago, Illinois, 60602, United States
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Chicago, Illinois, 60644, 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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North Dartmouth, Massachusetts, 02747, United States
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Farmington Hills, Michigan, 48336, United States
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Flint, Michigan, 48507, United States
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Rochester Hills, Michigan, 48307, United States
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Woodbury, Minnesota, 55125, United States
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Columbia, Missouri, 65203, United States
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Rolla, Missouri, 65401, United States
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St Louis, Missouri, 63141, United States
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Warrensburg, Missouri, 64093, United States
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Missoula, Montana, 59808, United States
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Bellevue, Nebraska, 68005, United States
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Bellevue, Nebraska, 68123, United States
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Las Vegas, Nevada, 89106, United States
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Las Vegas, Nevada, 89119, United States
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Skillman, New Jersey, 08558, United States
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Toms River, New Jersey, 08755, United States
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New Hyde Park, New York, 11040, United States
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New York, New York, 10036, United States
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The Bronx, New York, 10461, 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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Oklahoma City, Oklahoma, 73106, 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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Portland, Oregon, 97202, United States
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Erie, Pennsylvania, 16508, United States
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Warwick, Rhode Island, 02886, United States
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Gaffney, South Carolina, 29341, United States
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Spartanburg, South Carolina, 29303, United States
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Knoxville, Tennessee, 37909, United States
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Austin, Texas, 78759, United States
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Boerne, Texas, 78006, United States
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Corsicana, Texas, 75110, United States
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Dallas, Texas, 75225, United States
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El Paso, Texas, 79903, United States
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San Antonio, Texas, 78207, United States
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San Antonio, Texas, 78229, United States
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Sherman, Texas, 75092, 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, 1128, Argentina
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Buenos Aires, 1414, Argentina
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Buenos Aires, 1425, Argentina
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Buenos Aires, 1824, Argentina
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Buenos Aires, 1878, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Santa Fe, 2000, Argentina
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Brandýs nad Labem, Czechia
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Kralupy nad Vltavou, Czechia
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Lovosice, Czechia
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Neratovice, Czechia
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Prague, Czechia
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Rokycany, Czechia
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Varnsdorf, Czechia
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Berlin, 10119, 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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Darmstadt, Germany
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Dortmund, Germany
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Frankfurt, Germany
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Halle, Germany
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Hamburg, Germany
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Hessen, Germany
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Leipzig, Germany
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Lübeck, Germany
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Marburg, Germany
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Munich, Germany
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Neu-Isenburg, Germany
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Sachsen, 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, Serbia
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Kragujevac, Serbia
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Valjevo, Serbia
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Košice, Slovakia
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Žilina, Slovakia
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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, 02002, 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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Vinnytsia, Ukraine
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Zaporizhzhya, 69035, Ukraine
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Zaporizhzhya, 69600, Ukraine
Related Publications (1)
Chipps BE, Israel E, Beasley R, Panettieri RA Jr, Albers FC, Rees R, Dunsire L, Danilewicz A, Johnsson E, Cappelletti C, Papi A. Albuterol-Budesonide Pressurized Metered Dose Inhaler in Patients With Mild-to-Moderate Asthma: Results of the DENALI Double-Blind Randomized Controlled Trial. Chest. 2023 Sep;164(3):585-595. doi: 10.1016/j.chest.2023.03.035. Epub 2023 Mar 30.
PMID: 37003355RESULT
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
February 14, 2019
First Posted
February 20, 2019
Study Start
March 20, 2019
Primary Completion
July 20, 2021
Study Completion
July 20, 2021
Last Updated
April 13, 2023
Results First Posted
September 30, 2022
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share