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

Primary Purpose

Asthma

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Fluticasone propionate 100 mcg / salmeterol 50 mcg

Generic fluticasone propionate 100 mcg / salmeterol 50 mcg

Placebo

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment 1

Treatment 2

Treatment 3

Arm Description

Generic fluticasone propionate 100 mcg / salmeterol 50 mcg. Single puff, twice daily (approximately every 12 hr) for 4 weeks

Advair 100/50 Diskus pMDI containing fluticasone propionate 100mcg / salmeterol 50 mcg. Single puff, twice daily (approximately every 12 hr) for 4 weeks

Placebo inhalation. Single puff, twice daily (approximately every 12 hr) for 4 weeks

Outcomes

Primary Outcome Measures

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

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

Change in Forced Vital Capacity (FVC) results at the times of FEV1 measurements

Daily rescue medication used

The type and frequency of rescue medication used

Number and type of adverse events

Full Information

NCT ID

NCT02496715

First Posted

July 1, 2015

Last Updated

July 2, 2019

Sponsor

Actavis Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02496715

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Development terminated.

Study Start Date

September 2015 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Actavis Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

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

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment 1

Arm Type

Experimental

Arm Description

Generic fluticasone propionate 100 mcg / salmeterol 50 mcg. Single puff, twice daily (approximately every 12 hr) for 4 weeks

Arm Title

Treatment 2

Arm Type

Experimental

Arm Description

Advair 100/50 Diskus pMDI containing fluticasone propionate 100mcg / salmeterol 50 mcg. Single puff, twice daily (approximately every 12 hr) for 4 weeks

Arm Title

Treatment 3

Arm Type

Placebo Comparator

Arm Description

Placebo inhalation. Single puff, twice daily (approximately every 12 hr) for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Fluticasone propionate 100 mcg / salmeterol 50 mcg

Other Intervention Name(s)

Advair

Intervention Description

Brand inhaler containing pMDI containing fluticasone and salmeterol

Intervention Type

Drug

Intervention Name(s)

Generic fluticasone propionate 100 mcg / salmeterol 50 mcg

Other Intervention Name(s)

Generic Test

Intervention Description

Generic inhaler containing pMDI containing fluticasone and salmeterol

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo inhaler

Primary Outcome Measure Information:

Title

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

Description

Time Frame

up to 12 hours

Secondary Outcome Measure Information:

Title

Change in Forced Vital Capacity (FVC) results at the times of FEV1 measurements

Time Frame

Day 1 and Day 28

Title

Daily rescue medication used

Description

The type and frequency of rescue medication used

Time Frame

8 weeks

Title

Number and type of adverse events

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beverley Patterson, PhD

Organizational Affiliation

Actavis Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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