BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient
NCT05322707
Phase
Phase 3
Recruitment status
Completed
Participants
1,485
Lead sponsor
Cipla Ltd.
Start date
2022-04-15
Number of sites
- Summary
- The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in adult patient with Asthma
- Short title
- BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient
- Official title
- Multicenter Randomized Parallel-Group 6-Week Treatment Clinical Study to Assess BE of Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Comparison With Reference Product, Symbicort® in Adult Asthma Patients
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2023-08-29
- First posted
- 2022-04-12
- Registry last updated
- 2023-08-30
- Primary completion date
- 2023-08-15
- Start date
- 2022-04-15
- Actual participants
- 1,485
- Participants
- 1,485
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Cipla Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05322707
- ClinicalTrials.gov ID
- NCT05322707
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Investigators, Outcome assessors
Sources for study design
Area under the serial Force Expiration volume1
Timeframe: From time 0 to 12 hours
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment
Change in FEV1 from baseline
Timeframe: 6 weeks treatment
FEV1 measured in the morning prior to the dosing of inhaled medication on the last day of the 6 weeks treatment
Number and Severity of Adverse Events and Serious Adverse Events
Timeframe: 6 weeks treatment
Assessment of No. of AEs, its severity, and relatedness and SAE.,
Assessment of vital signs: Pulse rate
Timeframe: 6 weeks treatment
Assessment of vital signs
Number of participants with suspected oral infection performed with an oropharyngeal examination
Timeframe: 6 weeks treatment
Assessment of physical examination including oropharyngeal examination
Assessment of vital signs: Systolic and diastolic Blood Pressures
Timeframe: 6 weeks treatment
Assessment of vital signs: Systolic and diastolic Blood Pressures
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Healthy volunteers
- No
- Male or female patients who are 18-70 years of age
- Has moderate-to-severe asthma with a pre-bronchodilator FEV1 of ≥45% and <80% of the predicted normal value for the patient after withholding bronchodilators
- Has ≥15% and ≥0.20 L reversibility of FEV1 within 30 minutes following administration of 360 μg of albuterol (pMDI)
- Is stable on current chronic asthma treatment (documented asthma diagnosis and/or prescription for asthma medications) for at least 4 weeks prior to screening visit (Visit 1).
- Has been diagnosed with asthma as defined by the National Asthma Education and Prevention Program (NAEPP 2007) at least 6 months prior to screening
- Adult male or female patients of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control
- Has history of life-threatening asthma defined as an asthma episode(s) that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s), within past 1 year or during run-in period
- Has history of any asthma-related hospitalizations within the past one year prior to screening visit (Visit 1) or during the run-in period
- Has history of any pulmonary disorder other than asthma, including but not limited to: diagnosis of chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, bronchiectasis, chronic bronchitis, pulmonary hypertension, active pulmonary tuberculosis, or pulmonary carcinoma.
- Has current evidence of bronchopulmonary dysplasia or pulmonary fibrosis
- Has recent respiratory tract infection that is not resolved within 4 weeks of screening and is considered significant in the opinion of the investigator
- Patients who, in the opinion of the investigator, significantly abuse alcohol or drugs, will be excluded.
- Is taking any immunosuppressive medications within 4 weeks prior to the screening and during the study
- Use of systemic or oral corticosteroids within 2 months or intramuscular depot corticosteroid treatment 90 days prior to the screening or during the run-in period for any reason other than asthma.
- Women of childbearing potential who are lactating or pregnant at screening visit, as documented by a positive screening pregnancy test.
- Has previously been randomized in this study
Sources for eligibility
- Velocity Clinical ResearchMedford, United States
Sources for sites
Related records
Drugs (4)
Lead sponsors (1)
Conditions (1)
- Asthma Primary condition