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BE Study of Fluticasone Propionate/Salmeterol Inhalation Powder in Asthma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03394989
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : February 1, 2019
Information provided by (Responsible Party):
Cipla Ltd.

Brief Summary:
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in adult patients with asthma.

Condition or disease Intervention/treatment Phase
Bronchial Asthma Drug: Fluticasone propionate/salmeterol 100/50 µg Other: Placebo Drug: Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT Phase 3

Detailed Description:
This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points in adult patients with asthma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A multicenter, randomized, parallel-group, placebo-controlled
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Parallel-group, Placebo-controlled, 4-week Clinical Endpoint Bioequivalence Study Comparing Fluticasone Propionate/Salmeterol 100/50 µg Inhalation Powder With Advair® Diskus 100/50 µg in Asthma Patients
Actual Study Start Date : October 17, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Test
Fluticasone propionate/salmeterol 100/50 µg
Drug: Fluticasone propionate/salmeterol 100/50 µg
Test Arm: Dry powder inhaler

Active Comparator: Comparator
Fluticasone propionate/salmeterol 100/50 µg
Drug: Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT
Comparator Arm: Dry powder inhaler

Test Placebo
Other: Placebo

Primary Outcome Measures :
  1. Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) [ Time Frame: one day ]
    Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects (≥ 12 years of age) of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control
  • Diagnosed with asthma as defined by the National Asthma Education and Prevention Program (NAEPP)4 at least 12 weeks prior to screening.
  • Pre-bronchodilator FEV1 of ≥40% and ≤85% of the predicted value during the screening visit and on the first day of treatment.
  • Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had ≤ 10 pack-years of historical use.
  • ≥15% reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI).
  • Able to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for remainder of the study.
  • Able to replace current short-acting β agonists (SABAs) with salbutamol/albuterol inhaler for use as needed for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits).

Exclusion Criteria:

  • Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year or during the run-in period.
  • Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
  • Hypersensitivity to any sympathomimetic drug (e.g., salmeterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy
  • Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit or during the run-in period.
  • Factors (e.g., infirmity, disability or geographic location) that the investigator felt would likely limit the patient's compliance with the study protocol or scheduled clinic visits.
  • Use of Medication(s) with the potential to affect the course of asthma or to interact with sympathomimetic amines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03394989

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Contact: Bill Brashier, Doctor 09823834593
Contact: Mukesh Kumar, Doctor 09987655996

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United States, Florida
Combined Research Orlando Recruiting
Orlando, Florida, United States, 32807
Contact: Yenilady Estevez    407-440-4493   
Sponsors and Collaborators
Cipla Ltd.

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Responsible Party: Cipla Ltd. Identifier: NCT03394989     History of Changes
Other Study ID Numbers: U-FS-MU-AS3120
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Anti-Asthmatic Agents
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists