Clinical trial NCT05322707: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Cipla Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-12
Enrollment: 1485
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: This study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measures at different timepoints in adult patient with Asthma.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Area under the serial Force Expiration volume1
timeFrame: From time 0 to 12 hours
measure: Change in FEV1 from baseline
timeFrame: 6 weeks treatment
Secondary outcomes:
measure: Number and Severity of Adverse Events and Serious Adverse Events
timeFrame: 6 weeks treatment
measure: Assessment of vital signs: Pulse rate
timeFrame: 6 weeks treatment
measure: Number of participants with suspected oral infection performed with an oropharyngeal examination
timeFrame: 6 weeks treatment
measure: Assessment of vital signs: Systolic and diastolic Blood Pressures
timeFrame: 6 weeks treatment
Other outcomes:
Locations:
city: Medford
country: United States
facility: Velocity Clinical Research
state: Oregon
Study officials:
affiliation: Global Research Solution
name: Orlando Rivero, MD
role: PRINCIPAL_INVESTIGATOR
References: