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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. Read our disclaimer for details. Identifier: NCT03394989
Recruitment Status : Active, not recruiting
First Posted : January 9, 2018
Last Update Posted : January 27, 2020
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)
Actual Enrollment : 1366 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
Actual Primary Completion Date : December 3, 2019
Estimated Study Completion Date : March 31, 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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Patients who have signed informed consent form before initiation of any study related procedure.
  2. Male or female patients who are ≥18 years of age at the time informed consent is obtained.
  3. Documented diagnosis of asthma as defined by the National Asthma Education and Prevention Program (NAEPP) and diagnosed at least 12 weeks prior to screening.
  4. Patients with pre-bronchodilator forced expiratory volume in one second (FEV1) of 40% to 85% (both inclusive) of the predicted normal value at the Screening Visit V2.
  5. Patients who demonstrated an increase of ≥15% of FEV1 within 15 30 minutes following administration of albuterol at Screening Visit V2
  6. Patients who are stable on current asthma treatment for at least 4 weeks prior to Screening Visit V1.
  7. Patients who are able to discontinue their current asthma medications (if any) and any other prohibited medications throughout the study, per the protocol list of prohibited medications during study participation (see Section 6.3.2).
  8. Patients who are able to replace their current short-acting beta 2 agonist (SABA) inhaler with the study provided albuterol inhaler to be used as rescue medicine (as needed) throughout the study. Patients who are able to withhold SABAs for at least 6 hours prior to lung function assessments on study visits.
  9. Patient who are non-smokers or ex-smokers; and have had ≤10 pack years
  10. Patients who have not inhaled tobacco or consumed other tobacco containing products have not inhaled vaping products, drugs of abuse, or inhaled marijuana for at least 12 months prior to screening.
  11. Women of childbearing potential (WOCBP) must not be lactating or pregnant at screening, as documented by a negative screening pregnancy test
  12. Women of childbearing potential must commit to consistent and correct use of an acceptable method of birth control (at the investigator's discretion) throughout the study.

Exclusion criteria:

  1. History of life-threatening asthma defined as an asthma episode(s) that required intubation and/or was associated with hypercapnic, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s) within the past one year.
  2. History of any asthma-related hospitalizations within the past one year.
  3. Any asthma exacerbation requiring emergency room (ER) visits or systemic (including oral) corticosteroids within 2 months prior to signing the consent.
  4. Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia (prolonged QT interval as judged by the investigator). 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.
  5. Patients with uncontrolled allergic rhinitis.
  6. Clinical visual evidence of oral candidiasis.
  7. History of any adverse reaction; known hypersensitivity to any sympathomimetic drug
  8. Use of medication(s) with potential to affect the course of asthma or to interact with sympathomimetic amines throughout the study period.
  9. Recent viral or bacterial infection or infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 4 weeks of screening.
  10. Patients, who in the opinion of the investigator, significantly abuse alcohol or drugs will be excluded.
  11. Use of systemic (including oral) corticosteroids within 4 weeks or intramuscular depot corticosteroid treatment 90 days prior to screening for any reason other than asthma (see exclusion criteria #3 above).
  12. Patients taking any immunosuppressive medications within 4 weeks prior to screening and during the study.
  13. Factors (e.g., infirmity, disability, geographic location) that the investigator felt would likely limit the patients' compliance with the study protocol or scheduled clinic visits.
  14. Use of any investigational drug (approved or unapproved) within 30 days
  15. Study participation by clinical investigator site employees and/or their immediate relatives.
  16. Patients who are unable to produce valid and reproducible spirometry per American Thoracic Society/European Respiratory Society (ATS/ERS) standards at the screening visit or unable to use the electronic diary (e diary).
  17. Patients unable to use the inhalation powder device adequately.

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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United States, Florida
Combined Research Orlando
Orlando, Florida, United States, 32807
Sponsors and Collaborators
Cipla Ltd.
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Responsible Party: Cipla Ltd. Identifier: NCT03394989    
Other Study ID Numbers: U-FS-MU-AS3120
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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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
Anti-Asthmatic Agents
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