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

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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg; Drug: Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 1485
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Brijesh Wadekar, Doctor; Phone Number: 09927971349; Email: brijesh.wadekar@cipla.com
• Study Contact Backup: Name: Mukesh Kumar, Doctor; Phone Number: 09987655996; Email: Mukesh.kumar7@cipla.com

Study Locations

• United States
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg; Inhalation Aerosol, 2 actuations orally inhaled twice daily	Drug: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg; Inhalation aerosol, 2 actuations orally inhaled twice daily; Other Names: Test product
Active Comparator: Symbicort®; Inhalation Aerosol, 2 actuations orally inhaled twice daily	Drug: Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol; Inhalation aerosol, 2 actuations orally inhaled twice daily; Other Names: RLD
Placebo Comparator: Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg; Inhalation Aerosol, 2 actuations orally inhaled twice daily	Drug: Placebo; Inhalation aerosol, 2 actuations orally inhaled twice daily; Other Names: Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Severity of Adverse Events and Serious Adverse Events	Assessment of No. of AEs, its severity, and relatedness and SAE.,	6 weeks treatment
Assessment of vital signs: Pulse rate	Assessment of vital signs	6 weeks treatment
Number of participants with suspected oral infection performed with an oropharyngeal examination	Assessment of physical examination including oropharyngeal examination	6 weeks treatment
Assessment of vital signs: Systolic and diastolic Blood Pressures	Assessment of vital signs: Systolic and diastolic Blood Pressures	6 weeks treatment

Collaborators and Investigators

• Sponsor: Cipla Ltd.
• Investigators: Principal Investigator: Orlando Rivero, MD, Global Research Solution

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 29, 2023

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: CRD/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No