MedDataX Logo

Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease

NCT ID: NCT01323634

Last Updated: 2017-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

519 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-18

Study Completion Date

2011-12-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be a 7-day Follow-up period after the treatment period.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fluticasone Furoate / GW642444 (vilanterol)

Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)

Group Type EXPERIMENTAL

Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg

Intervention Type DRUG

inhalation powder

Fluticasone Propionate / salmeterol

Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)

Group Type ACTIVE_COMPARATOR

Fluticasone Propionate 250mcg/ salmeterol 50mcg

Intervention Type DRUG

inhalation powder

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg

inhalation powder

Intervention Type DRUG

Fluticasone Propionate 250mcg/ salmeterol 50mcg

inhalation powder

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Signed and dated written informed consent
* Male or females ≥ 40 years of age
* Established clinical history of COPD by ATS/ERS definition
* Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in protocol, used consistently and correctly
* Former or current smoker \> 10 pack years
* Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≤ 70% of predicted normal (NHANES III)

Exclusion Criteria

* Current diagnosis of asthma
* Subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
* Lung volume reduction surgery within previous 12 months
* Clinically significant abnormalities not due to COPD by chest x-ray
* Hospitalized for poorly controlled COPD within 12 weeks of Screening
* Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician
* Lower respiratory infection requiring antibiotics 6 weeks prior to Screening
* Uncontrolled or clinically significant (in opinion of PI) cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine, peptic ulcer disease, or hematological abnormalities
* Carcinoma not in complete remission for at least 5 years
* Subjects with history of hypersensitivity to study medications (e.g., beta-agonists, corticosteroid) or components of inhalation powder (e.g., lactose, magnesium stearate)
* Subjects with history of severe milk protein allergy that, in opinion of study physician, contraindicates subject's participation
* Known/suspected history of alcohol or drug abuse in the last 2 years
* Women who are pregnant or lactating or plan to become pregnant
* Subjects medically unable to withhold albuterol and/or ipratropium 4 hours prior to spirometry testing at each study visit
* Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)
* Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy \>12 hours a day
* Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study
* Non-compliance or inability to comply with study procedures or scheduled visits
* Affiliation with investigator site
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

GSK Investigational Site

Atlanta, Georgia, United States

Site Status

GSK Investigational Site

Madisonville, Kentucky, United States

Site Status

GSK Investigational Site

St Louis, Missouri, United States

Site Status

GSK Investigational Site

Charlotte, North Carolina, United States

Site Status

GSK Investigational Site

Raleigh, North Carolina, United States

Site Status

GSK Investigational Site

Columbus, Ohio, United States

Site Status

GSK Investigational Site

Easley, South Carolina, United States

Site Status

GSK Investigational Site

Greenville, South Carolina, United States

Site Status

GSK Investigational Site

Union, South Carolina, United States

Site Status

GSK Investigational Site

Waco, Texas, United States

Site Status

GSK Investigational Site

Benešov, , Czechia

Site Status

GSK Investigational Site

Blansko, , Czechia

Site Status

GSK Investigational Site

Kroměříž, , Czechia

Site Status

GSK Investigational Site

Kyjov, , Czechia

Site Status

GSK Investigational Site

Mělník, , Czechia

Site Status

GSK Investigational Site

Nový Jičín, , Czechia

Site Status

GSK Investigational Site

Rokycany, , Czechia

Site Status

GSK Investigational Site

Třebíč, , Czechia

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Wiesbaden, Hesse, Germany

Site Status

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Działdowo, , Poland

Site Status

GSK Investigational Site

Elblag, , Poland

Site Status

GSK Investigational Site

Inowrocław, , Poland

Site Status

GSK Investigational Site

Katowice, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Poznan, , Poland

Site Status

GSK Investigational Site

Wroclaw, , Poland

Site Status

GSK Investigational Site

Brasov, , Romania

Site Status

GSK Investigational Site

Brasov, , Romania

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Cluj-Napoca, , Romania

Site Status

GSK Investigational Site

Iași, , Romania

Site Status

GSK Investigational Site

Suceava, , Romania

Site Status

GSK Investigational Site

Timișoara, , Romania

Site Status

GSK Investigational Site

Barnaul, , Russia

Site Status

GSK Investigational Site

Barnaul, , Russia

Site Status

GSK Investigational Site

Kaluga, , Russia

Site Status

GSK Investigational Site

Kemerovo, , Russia

Site Status

GSK Investigational Site

Kursk, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Czechia Germany Poland Romania Russia

References

Explore related publications, articles, or registry entries linked to this study.

Dransfield MT, Feldman G, Korenblat P, LaForce CF, Locantore N, Pistolesi M, Watkins ML, Crim C, Martinez FJ. Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients. Respir Med. 2014 Aug;108(8):1171-9. doi: 10.1016/j.rmed.2014.05.008. Epub 2014 Jun 19.

Reference Type DERIVED
PMID: 24998880 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Dataset Specification

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

113109

Identifier Type: -

Identifier Source: org_study_id