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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol

Placebo

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Velocity Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Symbicort®

Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Arm Description

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Number and Severity of Adverse Events and Serious Adverse Events

Assessment of No. of AEs, its severity, and relatedness and SAE.,

Assessment of vital signs: Pulse rate

Assessment of vital signs

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

Assessment of physical examination including oropharyngeal examination

Assessment of vital signs: Systolic and diastolic Blood Pressures

Full Information

NCT ID

NCT05322707

First Posted

March 31, 2022

Last Updated

August 29, 2023

Sponsor

Cipla Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05322707

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

April 15, 2022 (Actual)

Primary Completion Date

August 15, 2023 (Actual)

Study Completion Date

August 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cipla Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1485 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Arm Type

Experimental

Arm Description

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Arm Title

Symbicort®

Arm Type

Active Comparator

Arm Description

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Arm Title

Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Arm Type

Placebo Comparator

Arm Description

Inhalation Aerosol, 2 actuations orally inhaled twice daily

Intervention Type

Drug

Intervention Name(s)

Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Other Intervention Name(s)

Test product

Intervention Description

Inhalation aerosol, 2 actuations orally inhaled twice daily

Intervention Type

Drug

Intervention Name(s)

Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol

Other Intervention Name(s)

RLD

Intervention Description

Inhalation aerosol, 2 actuations orally inhaled twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Intervention Description

Inhalation aerosol, 2 actuations orally inhaled twice daily

Primary Outcome Measure Information:

Title

Area under the serial Force Expiration volume1

Description

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

Time Frame

From time 0 to 12 hours

Title

Change in FEV1 from baseline

Description

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

Time Frame

6 weeks treatment

Secondary Outcome Measure Information:

Title

Number and Severity of Adverse Events and Serious Adverse Events

Description

Assessment of No. of AEs, its severity, and relatedness and SAE.,

Time Frame

6 weeks treatment

Title

Assessment of vital signs: Pulse rate

Description

Assessment of vital signs

Time Frame

6 weeks treatment

Title

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

Description

Assessment of physical examination including oropharyngeal examination

Time Frame

6 weeks treatment

Title

Assessment of vital signs: Systolic and diastolic Blood Pressures

Description

Assessment of vital signs: Systolic and diastolic Blood Pressures

Time Frame

6 weeks treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Orlando Rivero, MD

Organizational Affiliation

Global Research Solution

Official's Role

Principal Investigator

Facility Information:

Facility Name

Velocity Clinical Research

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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