AsthmaPhase 3NCT03562949
A BE Study to Compare Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg and QVAR® 40 mcg, Inhalation Aerosol
A Phase 3 study testing Test Product and Reference Product in people with Asthma, run by Amneal Ireland Limited at 12 sites in United States.
Trial summary
To compare the efficacy and safety profiles of Beclomethasone dipropionate Inhalation Aerosol, 40 mcg (test product) and QVAR 40 mcg (beclomethasone dipropionate HFA), Inhalation Aerosol (reference product) and to demonstrate that the efficacy of the 2 active products is superior to that of placebo in the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Test Product and Reference Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 761 participants
- Where
- 12 sitesUnited States
- Study dates
- 6 Dec 2018to 2 Aug 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female subjects of non-childbearing or of childbearing potential committing to consistent and correct use of an acceptable method of birth control.
- Diagnosis of asthma as defined by the National Asthma Education and Prevention Program at least 12 months prior to screening.
- Pre-bronchodilator FEV1 of >45% and <85% of predicted value during the screening visit and on the first day of treatment.
- >15% and >0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI).
- Patients should be stable on their chronic asthma treatment regimen for at least four weeks prior to enrollment.
- Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and having had <10 pack-years of historical use.
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- Ability to replace current short-acting β agonist (SABAs) with salbutamol/albuterol inhaler for use as needed for the duration of the study. Subjects should be able to withhold all inhaled SABAs for at least six hours prior to lung function assessments on study visits.
- Ability to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for remainder of the study.
- Willingness to give their written informed consent to participate in the study.
Who cannot join
- Life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year prior to the screening or during the run-in period.
- Significant respiratory disease other than asthma (COPD, interstitial lung disease, etc.)
- Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that, in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.
- Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle ear infection within four weeks prior to the screening, during the run-in period, or on the day of treatment.
- Hypersensitivity to any sympathomimetic drug (e.g., albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy.
- Patients receiving β2-blockers, anti-arrhythmics, anti-depressants, and monoamine oxidase inhibitors within 4 weeks prior to the screening.
- Patients who required systemic corticosteroids (for any reason) within the past 2 months.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
TTS Research
Boerne, Texas, 78006
Moonshine Research Center
Doral, Florida, 33166
Beach Clinical Research, Inc.
Huntington Beach, California, 92647
Downtown La Research Center
Los Angeles, California, 90017
Hope Clinical Trials, Inc.
Miami, Florida, 33165
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014
Monroe BioMedical Research
Monroe, North Carolina, 28112
Advanced Research for Health Improvement
Naples, Florida, 34102
Florida Institute for Clinical Research
Orlando, Florida, 32825
Innovation Research Center
Palmetto Bay, Florida, 33157
PCP for Life/ Mercury Clinical Research
Splendora, Texas, 77372
Florida Premier Research Institute
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Multiple-Dose, Placebo-Controlled, Multi-Center Study Comparing Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg to QVAR® 40 mcg (Beclomethasone Dipropionate HFA), Inhalation Aerosol in Treatment of Subjects With Asthma
To compare the efficacy and safety profiles of Beclomethasone dipropionate Inhalation Aerosol, 40 mcg (test product) and QVAR 40 mcg (beclomethasone dipropionate HFA), Inhalation Aerosol (reference product) and to demonstrate that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.
- Conditions
- Asthma
- Being tested
- Test Product, Reference Product, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ProductDrug
Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
Reference ProductDrug
Also called QVAR
QVAR® 40 mcg (Beclomethasone Dipropionate HFA)
PlaceboDrug
Placebo Product
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Test Product, 40 mcg, 2 x daily Receives: Drug: Test Product |
| Reference Product | Active comparator | Reference Product, 40 mcg, 2 x daily Receives: Drug: Reference Product |
| Placebo | Placebo comparator | Placebo Product 2 x daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-adjusted, pre-dose FEV1 on the last day of the 4-week treatment period
FEV1 measured in the morning prior dosing of inhaled medications on the last day of the 4-week treatment. The primary endpoint should be baseline adjusted (change from baseline).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start6 Dec 2018
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Why it stopped: Insufficient investigational product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amneal Ireland Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irshad Haque, Study director, Amneal Pharmaceuticals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562949
- Sponsor's protocol ID
- AI-BDP-001
- Status last verified
- Jan 2020
- First submitted
- 25 May 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multiple-Dose, Placebo-Controlled, Multi-Center Study Comparing Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg to QVAR® 40 mcg (Beclomethasone Dipropionate HFA), Inhalation Aerosol in Treatment of Subjects With Asthma
- ClinicalTrials.gov ID
- NCT03562949
- Acronym / sponsor ID
- AI-BDP-001
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient investigational product
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Amneal Ireland LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy and safety profiles of Beclomethasone dipropionate Inhalation Aerosol, 40 mcg (test product) and QVAR 40 mcg (beclomethasone dipropionate HFA), Inhalation Aerosol (reference product) and to demonstrate that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Test ProductTest Product, 40 mcg, 2 x daily |
| Reference Product | Active comparator | Drug: Reference ProductReference Product, 40 mcg, 2 x daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Product 2 x daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult male or female subjects of non-childbearing or of childbearing potential committing to consistent and correct use of an acceptable method of birth control.
- Diagnosis of asthma as defined by the National Asthma Education and Prevention Program at least 12 months prior to screening.
- Pre-bronchodilator FEV1 of >45% and <85% of predicted value during the screening visit and on the first day of treatment.
- >15% and >0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI).
- Patients should be stable on their chronic asthma treatment regimen for at least four weeks prior to enrollment.
Key exclusion criteria (7 listed)
- Life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year prior to the screening or during the run-in period.
- Significant respiratory disease other than asthma (COPD, interstitial lung disease, etc.)
- Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that, in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.
- Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle ear infection within four weeks prior to the screening, during the run-in period, or on the day of treatment.
- Hypersensitivity to any sympathomimetic drug (e.g., albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test ProductBeclomethasone Dipropionate Inhalation Aerosol, 40 mcg | Drug | Test Product |
| Reference ProductAlso: QVARQVAR® 40 mcg (Beclomethasone Dipropionate HFA) | Drug | Reference Product |
| PlaceboPlacebo Product | Drug | Placebo |
Primary outcome
Baseline-adjusted, pre-dose FEV1 on the last day of the 4-week treatment period
Time frame: 4 weeks
FEV1 measured in the morning prior dosing of inhaled medications on the last day of the 4-week treatment. The primary endpoint should be baseline adjusted (change from baseline).
Results and safety
The study was stopped early (reason given: Insufficient investigational product). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irshad Haque study director
Amneal Pharmaceuticals, LLC
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test Product and Reference Product in people with Asthma, run by Amneal Ireland Limited at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient investigational product). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline-adjusted, pre-dose FEV1 on the last day of the 4-week treatment period (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.