NCT05322707

Completed

Phase 3

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

Cipla Ltd.1 site in 1 country1,485 target enrollmentApril 15, 2022

ConditionsAsthma

InterventionsBudesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol Placebo

DrugsBudesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol Placebo

Overview

Phase: Phase 3
Intervention: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg
Conditions: Asthma
Sponsor: Cipla Ltd.
Enrollment: 1485
Locations: 1
Primary Endpoint: Change in FEV1 from baseline
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 15, 2022

End Date

August 29, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cipla Ltd.

Responsible Party

Sponsor

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

Arms & Interventions

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Intervention: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Symbicort®

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Intervention: Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol

Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Intervention: Placebo

Outcomes

Primary Outcomes

Change in FEV1 from baseline

Time Frame: 6 weeks treatment

FEV1 measured in the morning prior to the dosing of inhaled medication on the last day of the 6 weeks treatment

Area under the serial Force Expiration volume1

Time Frame: 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

Secondary Outcomes

Number and Severity of Adverse Events and Serious Adverse Events(6 weeks treatment)
Number of participants with suspected oral infection performed with an oropharyngeal examination(6 weeks treatment)
Assessment of vital signs: Pulse rate(6 weeks treatment)
Assessment of vital signs: Systolic and diastolic Blood Pressures(6 weeks treatment)