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Trial record 45 of 319 for:    FLUTICASONE AND SALMETEROL

Randomized, Placebo-controlled Study Comparing Efficacy of Fluticasone/Salmeterol Combination to Advair in Asthmatics

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ClinicalTrials.gov Identifier: NCT02496715
Recruitment Status : Withdrawn (Development terminated.)
First Posted : July 14, 2015
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Actavis Inc.

Brief Summary:
This is a pivotal trial that will examine therapeutic equivalence (BE) of a new generic fixed-dose combination product containing fluticasone propionate 100 mcg / salmeterol 50 mcg (as xinafoate salt) and reference listed drug (RLD) Advair® Diskus 100/50 in adult patients with chronic but stable asthma as defined in the National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP 3) guidelines

Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone propionate 100 mcg / salmeterol 50 mcg Drug: Generic fluticasone propionate 100 mcg / salmeterol 50 mcg Drug: Placebo Phase 3

Detailed Description:

This pivotal trial will examine therapeutic equivalence of a new generic fixed-dose combination product containing fluticasone propionate 100 mcg / salmeterol 50 mcg (as xinafoate salt) and reference listed drug (RLD) Advair® Diskus 100/50 in adult patients with chronic but stable asthma as defined in National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP 3) guidelines [2]. To ensure adequate study sensitivity the test and reference products should both be statistically superior to placebo (p<0.05) with regard to the BE study primary endpoints.

A secondary study objective is the safety and tolerability of the test compound.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Parallel, Placebo-controlled, Multiple Dose, Multicenter Study to Compare the Efficacy of Fluticasone/Salmeterol (Test) to Advair® Diskus (GSK) in Adult Asthma Patients
Study Start Date : September 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Treatment 1
Generic fluticasone propionate 100 mcg / salmeterol 50 mcg. Single puff, twice daily (approximately every 12 hr) for 4 weeks
Drug: Generic fluticasone propionate 100 mcg / salmeterol 50 mcg
Generic inhaler containing pMDI containing fluticasone and salmeterol
Other Name: Generic Test

Experimental: Treatment 2
Advair 100/50 Diskus pMDI containing fluticasone propionate 100mcg / salmeterol 50 mcg. Single puff, twice daily (approximately every 12 hr) for 4 weeks
Drug: Fluticasone propionate 100 mcg / salmeterol 50 mcg
Brand inhaler containing pMDI containing fluticasone and salmeterol
Other Name: Advair

Placebo Comparator: Treatment 3
Placebo inhalation. Single puff, twice daily (approximately every 12 hr) for 4 weeks
Drug: Placebo
Placebo inhaler




Primary Outcome Measures :
  1. Baseline-corrected area under the serial Forced Expiratory Volume in the first second (FEV1)-time effect curve calculated from time zero to 12 hours on the first day of the treatment [ Time Frame: up to 12 hours ]
    Baseline-corrected area under the serial FEV1-time effect curve calculated from time zero to 12 hours on the first day of the treatment (Visit 2, Day 1) to assess equivalence of test drug with reference listed drug (RLD) Advair® Diskus® 100/50, and to assess superiority over placebo


Secondary Outcome Measures :
  1. Change in Forced Vital Capacity (FVC) results at the times of FEV1 measurements [ Time Frame: Day 1 and Day 28 ]
  2. Daily rescue medication used [ Time Frame: 8 weeks ]
    The type and frequency of rescue medication used

  3. Number and type of adverse events [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or female subjects of non-childbearing or of childbearing potential committed 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),5 at least 6 months prior to screening
  • Moderate-to-severe asthma with a pre-bronchodilator FEV1 of >45% and <85% of predicted normal, measured at least 6 hours after short-acting β agonist (SABA)and at least 24 hours after the last dose of long-acting β agonist (LABA), at the screening visit and on the day of treatment
  • >15% and >0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI)
  • Patients should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to enrollment
  • Currently non-smoking; having not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and having < 10 pack-years of historical use
  • Able to replace current regularly scheduled short-acting β agonists (SABAs) with salbutamol/albuterol inhaler for use only on an as-needed basis 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)
  • Willing to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for the remainder of the study
  • Willingness to give their written informed consent to participate in the study

Exclusion Criteria:

  • Life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within the past year or during the run-in period
  • Significant respiratory disease other than asthma (chronic obstructive pulmonary disease (COPD), interstitial lung disease, etc.)
  • 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
  • Patients who required systemic corticosteroids (for any reason) within the past 4 weeks
  • Hypersensitivity to any sympathomimetic drug (e.g., formoterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy
  • Patients currently receiving β-blockers

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 ClinicalTrials.gov identifier (NCT number): NCT02496715


Sponsors and Collaborators
Actavis Inc.
Investigators
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Study Director: Beverley Patterson, PhD Actavis Inc.

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Responsible Party: Actavis Inc.
ClinicalTrials.gov Identifier: NCT02496715     History of Changes
Other Study ID Numbers: ACT-2014-075
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists