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NCT02301975 · ClinicalTrials.gov registry record · Phase 3

An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma

A Phase 3 study of Asthma, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
1,526
Enrollment target
20
Study locations

NCT02301975 is a Phase 3 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,526 participants, roughly in line with the 1,559-participant average among 374 other Asthma trials with a reported enrollment target. The trial reports 20 study locations across 9 states.

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The verdict

NCT02301975, a Phase 3 study of Asthma, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
1,526 participants
Enrollment target
20
Study locations

Study Summary

This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate \[FP\]/salmeterol 250/50 microgram \[mcg\]twice daily \[BD\]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA. SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.

Conditions Studied

Asthma

Interventions

  • DRUG Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler
  • DRUG Placebo inhalation powders via ELLIPTA inhaler
  • DRUG Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler
  • DRUG Placebo inhalation powder via ACCUHALER/DISKUS inhaler
  • DRUG Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler

Study Locations (20)

California

  • GSK Investigational Site - Huntington Beach
  • GSK Investigational Site - Riverside
  • GSK Investigational Site - Rolling Hills Estates
  • GSK Investigational Site - San Diego
  • GSK Investigational Site - Upland

North Carolina

  • GSK Investigational Site - Charlotte
  • GSK Investigational Site - Gastonia
  • GSK Investigational Site - Hendersonville
  • GSK Investigational Site - Huntersville

Florida

  • GSK Investigational Site - Miami
  • GSK Investigational Site - Miami

Maryland

  • GSK Investigational Site - Baltimore
  • GSK Investigational Site - Columbia

Minnesota

  • GSK Investigational Site - Minneapolis
  • GSK Investigational Site - Plymouth

Missouri

  • GSK Investigational Site - Columbia
  • GSK Investigational Site - Rolla

Colorado

  • GSK Investigational Site - Denver

Georgia

  • GSK Investigational Site - Albany

Trial Details

FieldValue
Enrollment Target 1,526 participants
Start Date 2015-03-01
Est. Completion 2016-11-25
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT02301975

The ClinicalTrials.gov registry entry for NCT02301975 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,526 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 1,559-participant average among 374 other Asthma trials with a reported enrollment target. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 5 interventions - of which Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler is the first listed.

NCT02301975 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, North Carolina, Florida.

Frequently Asked Questions

What is clinical trial NCT02301975 about?

NCT02301975 is a clinical study titled "An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent Asthma". This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticason...

What is the current status of trial NCT02301975?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,526 participants. The study started on 2015-03-01. Estimated completion is 2016-11-25.

What conditions does trial NCT02301975 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT02301975?

The interventions under investigation include: Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler (DRUG), Placebo inhalation powders via ELLIPTA inhaler (DRUG), Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler (DRUG), Placebo inhalation powder via ACCUHALER/DISKUS inhaler (DRUG), Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler (DRUG).

Who is sponsoring clinical trial NCT02301975?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02301975 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.