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

NCT05322707 | Completed Phase 3 FDA Drug

• 1 other identifier: CRD/20
• Study Type: interventional
• Target: 1,485
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Area under the serial Force Expiration volume1

  Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment

  From time 0 to 12 hours

• Change in FEV1 from baseline

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

  6 weeks treatment

Secondary Outcomes (4)

• Number and Severity of Adverse Events and Serious Adverse Events

  6 weeks treatment

• Assessment of vital signs: Pulse rate

  6 weeks treatment

• Number of participants with suspected oral infection performed with an oropharyngeal examination

  6 weeks treatment

• Assessment of vital signs: Systolic and diastolic Blood Pressures

  6 weeks treatment

Study Arms (3)

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

EXPERIMENTAL

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Drug: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Symbicort®

ACTIVE COMPARATOR

Inhalation Aerosol, 2 actuations orally inhaled twice daily

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

Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

PLACEBO COMPARATOR

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Drug: Placebo

Interventions

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg DRUG

Inhalation aerosol, 2 actuations orally inhaled twice daily

Also known as: Test product

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol DRUG

Inhalation aerosol, 2 actuations orally inhaled twice daily

Also known as: RLD

Symbicort®

Placebo DRUG

Inhalation aerosol, 2 actuations orally inhaled twice daily

Also known as: Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cipla Ltd.: lead

Study Sites (1)

Velocity Clinical Research

Medford, Oregon, 97504, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Orlando Rivero, MD

  Global Research Solution

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 12, 2022
• Study Start: April 15, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 29, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)