BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient

NCT ID: NCT05322707

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1485 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2023-08-29

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Group Type: EXPERIMENTAL

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Intervention Type: DRUG

Inhalation aerosol, 2 actuations orally inhaled twice daily

Symbicort®

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Group Type: ACTIVE_COMPARATOR

Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol

Intervention Type: DRUG

Inhalation aerosol, 2 actuations orally inhaled twice daily

Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inhalation aerosol, 2 actuations orally inhaled twice daily

Interventions

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Inhalation aerosol, 2 actuations orally inhaled twice daily

Intervention Type: DRUG

Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol

Inhalation aerosol, 2 actuations orally inhaled twice daily

Intervention Type: DRUG

Placebo

Inhalation aerosol, 2 actuations orally inhaled twice daily

Intervention Type: DRUG

Other Intervention Names

Test product; RLD; Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cipla Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Orlando Rivero, MD

Role: PRINCIPAL_INVESTIGATOR

Global Research Solution

Locations

Velocity Clinical Research

Medford, Oregon, United States

Countries

United States

Other Identifiers

CRD/20

Identifier Type: -

Identifier Source: org_study_id