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

Cipla

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg; Drug: Placebo; Drug: Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol

Study type: Interventional

Funder types: Industry

Identifiers

NCT05322707

CRD/20

Details and patient eligibility

About

The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in adult patient with Asthma

Full 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.

Enrollment: 1,485 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,485 participants in 3 patient groups, including a placebo group

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Experimental group

Description:

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Treatment:

Drug: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Symbicort®

Active Comparator group

Description:

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Treatment:

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

Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Placebo Comparator group

Description:

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Treatment:

Drug: Placebo