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

  • STATUS
    Recruiting
  • days left to enroll
    77
  • participants needed
    1485
  • sponsor
    Cipla Ltd.
Updated on 23 May 2022

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.

Details
Condition Asthma
Treatment Placebo, Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg, Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol
Clinical Study IdentifierNCT05322707
SponsorCipla Ltd.
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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