An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects
BEAM
An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler) in Asthmatic Subjects.
1 other identifier
interventional
610
1 country
134
Brief Summary
The purpose of this study is to evaluate the dose-response of different doses of CHF 781 Pressurized Metered Dose Inhaler (pMDI) on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target patient population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Jul 2017
Typical duration for phase_2 asthma
134 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
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
March 21, 2017
CompletedStudy Start
First participant enrolled
July 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2018
CompletedResults Posted
Study results publicly available
December 14, 2021
CompletedDecember 14, 2021
December 1, 2021
1.3 years
March 8, 2017
October 29, 2021
December 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pre-dose Morning FEV1 at Week 8 - Change From Baseline
Change from baseline in pre-dose morning FEV1 (average of pre-dose FEV1 measurements) at Week 8. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. Definitions: Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;
Baseline, Week 8
Secondary Outcomes (15)
Pre-dose Morning FEV1 at Week 4 - Change From Baseline
Baseline, Week 4
Pre-dose Morning FVC at Week 4 and 8 - Change From Baseline
Baseline, Week 4, Week 8
Asthma Control Questionnaire-7© (ACQ-7) Score at Week 4 and Week 8 - Change From Baseline
Baseline, Week 4, Week 8
Average Use of Rescue Medication - Change From Baseline
Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
Percentage (%) of Rescue Medication-free Days - Change From Baseline
Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)
- +10 more secondary outcomes
Study Arms (5)
Treatment A
EXPERIMENTALCHF 718 pMDI 100 μg Total Daily Dose (TDD), Dose 1; CHF 718 pMDI 50 μg/actuation: 1 inhalation twice daily (BID);
Treatment B
EXPERIMENTALCHF 718 pMDI 400 μg Total Daily Dose (TDD) 400 μg, Dose 2; CHF 718 pMDI 100 μg/actuation: 2 inhalations BID;
Treatment C
EXPERIMENTALCHF 718 pMDI Total Daily Dose (TDD) 800 μg, Dose 3; CHF 718 pMDI 100 μg/actuation: 4 inhalations BID;
Treatment D
PLACEBO COMPARATORPlacebo Control, Placebo; CHF 718 pMDI matched Placebo: 4 inhalations BID;
Treatment E
ACTIVE COMPARATORBeclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA), Total Daily Dose (TDD) 320 µg; QVAR® 80 μg/actuation: 2 inhalations BID;
Interventions
Dose Response: Test one of three different doses of CHF 718 pMDI
Eligibility Criteria
You may qualify if:
- Male or female subjects aged ≥18 and ≤75 years who have signed an Informed Consent form prior to initiation of any study-related procedure.
- A diagnosis of asthma as defined in the Global Initiative for Asthma (GINA) Report, 2016, documented for at least 1 year prior to screening.
- Subjects with poorly controlled or uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire 7 © (ACQ-7) ≥1.5 (this criterion must be met at screening and at randomization visits).
- Subjects with a pre-bronchodilator Forced Expiratory Volume in the 1st Second (FEV1) ≥50% and \<85% of their predicted normal value, after appropriate washout from bronchodilators, at the screening and randomization visits.
- Subjects with a positive response to a reversibility test at screening (pre - post BD), within 1 year prior to or at screening defined as ΔFEV1≥12% and ≥200 mL over baseline within 30 minutes after inhaling 4 puffs of albuterol HFA 90µg/actuation.
- Use of inhaled corticosteroids (low/medium dose according to GINA Report 2016) with or without a long-acting bronchodilator (LABD) for 3 months (stable dose in the last 4 weeks) before screening visit (V).
- A cooperative attitude and ability to demonstrate correct use of the diary, peak flow meter, and pMDI inhalers.
- A basal morning (7-10 am) serum cortisol level between 7-28 µg/dL at screening visit (V1).
- A Body Mass Index (BMI): 18.5 ≤ BMI \<35 kg/m\^2.
You may not qualify if:
- Pregnant (as evident by a positive urine human chorionic gonadotropin (hCG) or serum β-hCG test) or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use a highly effective birth control method
- Subjects who suffer from chronic obstructive pulmonary disease (COPD) as defined by the GOLD Report 2017, or are suspected of having Asthma COPD Overlap Syndrome (ACOS) as defined in GINA Report, 2016.
- Inability to carry out pulmonary lung function testing, to comply with study procedures or with study drug intake.
- Current smokers or ex-smokers (tobacco, vapor cigarettes, marijuana) with a smoking history of \>10 pack-years or having stopped smoking one year or less prior to screening visit.
- History of life-threatening asthma, clinically significant uncontrolled disease or respiratory infection.
- An asthma exacerbation requiring oral corticosteroids within 3 months or hospitalization within 6 months prior to screening.
- Subjects with unresolved bacterial or viral respiratory tract, sinus or middle ear infection affecting asthma status within 2 weeks prior to screening.
- Subjects who received a vaccination within 2 weeks prior to screening or during the run-in.
- Subjects with oral candidiasis at screening or at randomization.
- Subjects with any clinically significant, uncontrolled condition
- Subjects who have clinically significant cardiovascular condition
- Subjects who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the subject according to Investigator's judgement.
- Subjects whose 12-lead ECG shows Fridericia corrected QT interval (QTcF) \>450 ms for males or QTcF \>470 ms for females at screening and randomization visits.
- Subjects with known intolerance/hypersensitivity or contra-indication to treatment with ß2-adrenergic receptor agonists, inhaled corticosteroids or propellant gases/excipients.
- Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-Immunoglobulin E (IgE), anti-Interleukin 5 (IL5), or other monoclonal or polyclonal antibodies within 12 weeks prior to screening.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (134)
Chiesi Investigational Site
Birmingham, Alabama, 35244, United States
Chiesi Investigational Site
Montgomery, Alabama, 36106, United States
Chiesi Investigational Site
Phoenix, Arizona, 85014, United States
Chiesi Investigational Site
Surprise, Arizona, 85374, United States
Chiesi Investigational Site
Tempe, Arizona, 85283, United States
Chiesi Investigational Site
Little Rock, Arkansas, 72209, United States
Chiesi Investigational Site
Anaheim, California, 92801, United States
Chiesi Investigational Site
Encinitas, California, 92024, United States
Chiesi Investigational Site
Escondido, California, 92025, United States
Chiesi Investigational Site
Fullerton, California, 92835, United States
Chiesi Investigational Site
Huntington Beach, California, 92647, United States
Chiesi Investigational Site
Long Beach, California, 90806, United States
Chiesi Investigational Site
Los Angeles, California, 90017, United States
Chiesi Investigational Site
Los Angeles, California, 90025, United States
Chiesi Investigational Site
Los Angeles, California, 90048, United States
Chiesi Investigational Site
Newport Beach, California, 92663, United States
Chiesi Investigational Site
North Hollywood, California, 91606, United States
Chiesi Investigational Site
Rolling Hills Estates, California, 90274, United States
Chiesi Investigational Site
Sacramento, California, 95821, United States
Chiesi Investigational Site
San Diego, California, 92120, United States
Chiesi Investigational Site
San Diego, California, 92123, United States
Chiesi Investigational Site
San Jose, California, 95117, United States
Chiesi Investigational Site
Tustin, California, 92780, United States
Chiesi Investigational Site
Westminster, California, 92683, United States
Chiesi Investigational Site
Boulder, Colorado, 80301, United States
Chiesi Investigational Site
Colorado Springs, Colorado, 80907, United States
Chiesi Investigational Site
Denver, Colorado, 80230, United States
Chiesi Investigational Site
Greenwood, Colorado, 80112, United States
Chiesi Investigational Site
Wheat Ridge, Colorado, 80033, United States
Chiesi Investigational Site
Aventura, Florida, 33180, United States
Chiesi Investigational Site
Clearwater, Florida, 33765, United States
Chiesi Investigational Site
Daytona Beach, Florida, 32117, United States
Chiesi Investigational Site
Doral, Florida, 33166, United States
Chiesi Investigational Site
Gainesville, Florida, 32607, United States
Chiesi Investigational Site
Hialeah, Florida, 33016, United States
Chiesi Investigational Site
Kissimmee, Florida, 34741, United States
Chiesi Investigational Site
Lauderdale Lakes, Florida, 33319, United States
Chiesi Investigational Site
Loxahatchee Groves, Florida, 33470, United States
Chiesi Investigational Site
Maitland, Florida, 32751, United States
Chiesi Investigational Site
Miami, Florida, 33133, United States
Chiesi Investigational Site
Miami, Florida, 33144, United States
Chiesi Investigational Site
Miami, Florida, 33157, United States
Chiesi Investigational Site
Miami, Florida, 33165, United States
Chiesi Investigational Site
Miami, Florida, 33173, United States
Chiesi Investigational Site
Orlando, Florida, 32801, United States
Chiesi Investigational Site
Palmetto Bay, Florida, 33157, United States
Chiesi Investigational Site
Plantation, Florida, 33322, United States
Chiesi Investigational Site
Pompano Beach, Florida, 33060, United States
Chiesi Investigational Site
Saint Cloud, Florida, 34769, United States
Chiesi Investigational Site
Sarasota, Florida, 34239, United States
Chiesi Investigational Site
Winter Park, Florida, 32789, United States
Chiesi Investigational Site
Dacula, Georgia, 30019, United States
Chiesi Investigational Site
Duluth, Georgia, 30096, United States
Chiesi Investigational Site
Gainesville, Georgia, 30501, United States
Chiesi Investigational Site
Marietta, Georgia, 30060, United States
Chiesi Investigational Site
Savannah, Georgia, 31405, United States
Chiesi Investigational Site
Chicago, Illinois, 60607, United States
Chiesi Investigational Site
Chicago, Illinois, 60612, United States
Chiesi Investigational Site
Crowley, Louisiana, 70526, United States
Chiesi Investigational Site
New Orleans, Louisiana, 70124, United States
Chiesi Investigational Site
Baltimore, Maryland, 21236, United States
Chiesi Investigational Site
Bethesda, Maryland, 20814, United States
Chiesi Investigational Site
Fall River, Massachusetts, 02720, United States
Chiesi Investigational Site
Fall River, Massachusetts, 02721, United States
Chiesi Investigational Site
North Dartmouth, Massachusetts, 02747, United States
Chiesi Investigational Site
South Dartmouth, Massachusetts, 02747, United States
Chiesi Investigational Site
Detroit, Michigan, 48202, United States
Chiesi Investigational Site
Minneapolis, Minnesota, 55402, United States
Chiesi Investigational Site
Columbia, Missouri, 65203, United States
Chiesi Investigational Site
Festus, Missouri, 63028, United States
Chiesi Investigational Site
Rolla, Missouri, 65401, United States
Chiesi Investigational Site
St Louis, Missouri, 63110, United States
Chiesi Investigational Site
St Louis, Missouri, 63141, United States
Chiesi Investigational Site
Warrensburg, Missouri, 64093, United States
Chiesi Investigational Site
Missoula, Montana, 59808, United States
Chiesi Investigational Site
Omaha, Nebraska, 68114, United States
Chiesi Investigational Site
Las Vegas, Nevada, 89102, United States
Chiesi Investigational Site
Las Vegas, Nevada, 89146, United States
Chiesi Investigational Site
Skillman, New Jersey, 08558, United States
Chiesi Investigational Site
Albuquerque, New Mexico, 87108, United States
Chiesi Investigational Site
Albuquerque, New Mexico, 87109, United States
Chiesi Investigational Site
Brooklyn, New York, 11201, United States
Chiesi Investigational Site
New York, New York, 10016, United States
Chiesi Investigational Site
New York, New York, 10022, United States
Chiesi Investigational Site
The Bronx, New York, 10455, United States
Chiesi Investigational Site
Charlotte, North Carolina, 28207, United States
Chiesi Investigational Site
Charlotte, North Carolina, 28277, United States
Chiesi Investigational Site
Gastonia, North Carolina, 28054, United States
Chiesi Investigational Site
Hendersonville, North Carolina, 28739, United States
Chiesi Investigational Site
Hickory, North Carolina, 28601, United States
Chiesi Investigational Site
Monroe, North Carolina, 28112, United States
Chiesi Investigational Site
Mooresville, North Carolina, 28117, United States
Chiesi Investigational Site
Winston-Salem, North Carolina, 27103, United States
Chiesi Investigational Site
Cincinnati, Ohio, 45231, United States
Chiesi Investigational Site
Cincinnati, Ohio, 45242, United States
Chiesi Investigational Site
Dayton, Ohio, 45409, United States
Chiesi Investigational Site
Dayton, Ohio, 45417, United States
Chiesi Investigational Site
Grove City, Ohio, 43123, United States
Chiesi Investigational Site
Munroe Falls, Ohio, 44262, United States
Chiesi Investigational Site
Toledo, Ohio, 43617, United States
Chiesi Investigational Site
Edmond, Oklahoma, 73034, United States
Chiesi Investigational Site
Medford, Oregon, 97504, United States
Chiesi Investigational Site
Portland, Oregon, 97202, United States
Chiesi Investigational Site
East Providence, Rhode Island, 02914, United States
Chiesi Investigational Site
East Providence, Rhode Island, 02941, United States
Chiesi Investigational Site
Warwick, Rhode Island, 02886, United States
Chiesi Investigational Site
Anderson, South Carolina, 29621, United States
Chiesi Investigational Site
Gaffney, South Carolina, 29340, United States
Chiesi Investigational Site
Greenville, South Carolina, 29615, United States
Chiesi Investigational Site
Rock Hill, South Carolina, 29732, United States
Chiesi Investigational Site
Spartanburg, South Carolina, 29301, United States
Chiesi Investigational Site
Spartanburg, South Carolina, 29303, United States
Chiesi Investigational Site
Union, South Carolina, 29379, United States
Chiesi Investigational Site
Chattanooga, Tennessee, 37419, United States
Chiesi Investigational Site
Chattanooga, Tennessee, 37421, United States
Chiesi Investigational Site
Knoxville, Tennessee, 37909, United States
Chiesi Investigational Site
Smyrna, Tennessee, 37167, United States
Chiesi Investigational Site
Spring Hill, Tennessee, 37174, United States
Chiesi Investigational Site
Allen, Texas, 75013, United States
Chiesi Investigational Site
Beaumont, Texas, 77702, United States
Chiesi Investigational Site
Cypress, Texas, 77429, United States
Chiesi Investigational Site
Dallas, Texas, 75224, United States
Chiesi Investigational Site
Dallas, Texas, 75231, United States
Chiesi Investigational Site
El Paso, Texas, 79903, United States
Chiesi Investigational Site
McKinney, Texas, 75069, United States
Chiesi Investigational Site
Pearland, Texas, 77584, United States
Chiesi Investigational Site
Plano, Texas, 75093, United States
Chiesi Investigational Site
San Antonio, Texas, 78217, United States
Chiesi Investigational Site
Sherman, Texas, 75092, United States
Chiesi Investigational Site
St. George, Utah, 84790, United States
Chiesi Investigational Site
South Burlington, Vermont, 05403, United States
Chiesi Investigational Site
Norfolk, Virginia, 23507, United States
Chiesi Investigational Site
Everett, Washington, 98208, United States
Chiesi Investigational Site
Greenfield, Wisconsin, 53228, United States
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PMID: 34030555RESULT
Related Links
- From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017.
- COPD Foundation - What is COPD
- Global Initiative For Asthma - GINA Report 2016
- Centers for Disease Control and Prevention - Most Recent Asthma Data
- Chiesi Farmaceutici S.p.A. - Respiratory
- Chiesi Farmaceutici S.p.A - Press Release: Chiesi Farmaceutifici is the first company to submit a marketing authorisation application to the European Medicine Agency for a triple combination for the treatment of COPD
- Wikipedia entry - Beclomethasone dipropionate
- WebMD LLC - Serum Cortisol
- Quest Diagnostics- Cortisol, Free and Cortisone, 24 Hour Urine with Creatinine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Transparency
- Organization
- Chiesi Farmaceutici S.p.A.
Study Officials
- PRINCIPAL INVESTIGATOR
David Bernstein, MD
Bernstein Clinical Research Center, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2017
First Posted
March 21, 2017
Study Start
July 28, 2017
Primary Completion
November 28, 2018
Study Completion
December 5, 2018
Last Updated
December 14, 2021
Results First Posted
December 14, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share