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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05322707
• Other study ID #: CRD/20
• Status: Completed
• Phase: Phase 3
• Start date: April 15, 2022
• Est. completion date: August 29, 2023

Study information

• Verified date: August 2023
• Source: Cipla Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1485
• Est. completion date: August 29, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide 80 µg and Formoterol Fumarate Dihydrate 4.5 µg
Inhalation aerosol, 2 actuations orally inhaled twice daily
• Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol
Inhalation aerosol, 2 actuations orally inhaled twice daily
• Placebo
Inhalation aerosol, 2 actuations orally inhaled twice daily

Locations

Country	Name	City	State
United States	Velocity Clinical Research	Medford	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Cipla Ltd.

Country where clinical trial is conducted

United States, 

Outcome

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