Bronchial AsthmaPhase 3QVRNCT04051710
Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH
A Phase 3 study testing Test Product and Reference Product in people with Bronchial Asthma, run by Aurobindo Pharma Ltd at 1 site in India.
Trial summary
To compare the therapeutic equivalence of Beclomethasone Dipropionate MDI (Inhalation Aerosol) 0.04 mg/ INH with the marketed QVAR® 40 mcg (Beclomethasone dipropionate hydrofluoroalkane (HFA)) and to demonstrate superiority of both active treatments over placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchial 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
- 1,550 participants
- Where
- 1 siteIndia
- Study dates
- 12 Mar 2019to 20 Dec 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 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
1 site in 1 country.
India1 site
Maharashtra Medical Foundation Joshi Hospital
Pune, Maharashtra, 411004
About this study
Official title: Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate Efficacy and Safety of Beclomethasone Dipropionate Metered Dose Inhaler (Inhalation Aerosol) (0.04mg/ INH) in Male and/ or Female Subjects With Asthma
To compare the therapeutic equivalence of Beclomethasone Dipropionate MDI (Inhalation Aerosol) 0.04 mg/ INH with the marketed QVAR® 40 mcg (Beclomethasone dipropionate hydrofluoroalkane (HFA)) and to demonstrate superiority of both active treatments over placebo.
Read the detailed description
This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of improvement in FEV1 measured before and after 4 weeks of treatment in adult patients with chronic stable asthma.
- Conditions
- Bronchial 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
Also called Test
Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
Reference ProductDrug
Also called QVAR
Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
PlaceboDrug
Placebo Product
| Study group | Role | What they receive |
|---|---|---|
| Group-I (Test) | Experimental | One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Test) twice daily. Receives: Drug: Test Product |
| Group-II (Reference) | Active comparator | One inhalation of QVAR® 40 mcg (Beclomethasone dipropionate HFA), Inhalation Aerosol twice daily. Receives: Drug: Reference Product |
| Group-III (Placebo) | Placebo comparator | One inhalation of Placebo Inhalation Aerosol twice daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 From Pre Dose to End of Treatment
Mean change in Forced Expiratory volume in 1 second (FEV 1) from baseline to end of study visit
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 posted9 Aug 2019
- Study start12 Mar 2019
- Primary completion29 Aug 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bronchial 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
- 1,550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurobindo Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Marialouis, Study director, Aurobindo Pharma USA Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051710
- Sponsor's protocol ID
- CR176-17
- Acronym
- QVR
- Status last verified
- Oct 2020
- First submitted
- 5 Aug 2019
- Last updated
- 13 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Not decided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate Efficacy and Safety of Beclomethasone Dipropionate Metered Dose Inhaler (Inhalation Aerosol) (0.04mg/ INH) in Male and/ or Female Subjects With Asthma
- ClinicalTrials.gov ID
- NCT04051710
- Acronym / sponsor ID
- QVR / CR176-17
- Conditions
- Bronchial Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,550 participants (actual)
- Lead sponsor
- Aurobindo Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Posted 13 Nov 2020
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 therapeutic equivalence of Beclomethasone Dipropionate MDI (Inhalation Aerosol) 0.04 mg/ INH with the marketed QVAR® 40 mcg (Beclomethasone dipropionate hydrofluoroalkane (HFA)) and to demonstrate superiority of both active treatments over placebo.
Detailed description
This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of improvement in FEV1 measured before and after 4 weeks of treatment in adult patients with chronic stable asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group-I (Test) | Experimental | Drug: Test ProductOne inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Test) twice daily. |
| Group-II (Reference) | Active comparator | Drug: Reference ProductOne inhalation of QVAR® 40 mcg (Beclomethasone dipropionate HFA), Inhalation Aerosol twice daily. |
| Group-III (Placebo) | Placebo comparator | Drug: PlaceboOne inhalation of Placebo Inhalation Aerosol twice daily. |
Who may qualify
- Ages
- 18 to 65 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 ProductAlso: TestBeclomethasone Dipropionate Inhalation Aerosol, 40 mcg | Drug | Group-I (Test) |
| Reference ProductAlso: QVARBeclomethasone Dipropionate Inhalation Aerosol, 40 mcg | Drug | Group-II (Reference) |
| PlaceboPlacebo Product | Drug | Group-III (Placebo) |
Primary outcome
Change in FEV1 From Pre Dose to End of Treatment
Time frame: 4 weeks
Mean change in Forced Expiratory volume in 1 second (FEV 1) from baseline to end of study visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Not decided
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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.
Joseph Marialouis study director
Aurobindo Pharma USA Inc
1 site 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 Bronchial Asthma, run by Aurobindo Pharma Ltd at 1 site in India.
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: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Yes. Results are posted in the registry (first posted 13 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in FEV1 From Pre Dose to End of Treatment (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 Nov 2020.