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Study Evaluating 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 (COPD)

NCT ID: NCT01323621

Last Updated: 2018-02-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-18

Study Completion Date

2012-01-24

Brief Summary

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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.

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Detailed Description

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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

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Double-dummy placebo

Intervention Type DRUG

inhalation powder

Salbutamol as needed

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

Double-dummy placebo

Intervention Type DRUG

inhalation powder

Salbutamol as needed

Intervention Type DRUG

inhalation powder

Interventions

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Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg

inhalation powder

Intervention Type DRUG

Fluticasone Propionate 250mcg / salmeterol 50mcg

inhalation powder

Intervention Type DRUG

Double-dummy placebo

inhalation powder

Intervention Type DRUG

Salbutamol as needed

inhalation powder

Intervention Type DRUG

Eligibility Criteria

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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

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Jasper, Alabama, United States

Site Status

GSK Investigational Site

Riverside, California, United States

Site Status

GSK Investigational Site

DeLand, Florida, United States

Site Status

GSK Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

GSK Investigational Site

Minneapolis, Minnesota, United States

Site Status

GSK Investigational Site

Cincinnati, Ohio, United States

Site Status

GSK Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

GSK Investigational Site

Medford, Oregon, United States

Site Status

GSK Investigational Site

Gaffney, South Carolina, United States

Site Status

GSK Investigational Site

Orangeburg, South Carolina, United States

Site Status

GSK Investigational Site

Seneca, South Carolina, United States

Site Status

GSK Investigational Site

Spartanburg, South Carolina, United States

Site Status

GSK Investigational Site

Boerne, Texas, United States

Site Status

GSK Investigational Site

Lübeck, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Napoli, Campania, Italy

Site Status

GSK Investigational Site

San Felice A Cancello Caserta, Campania, Italy

Site Status

GSK Investigational Site

Telese Terme (BN), Campania, Italy

Site Status

GSK Investigational Site

Parma, Emilia-Romagna, Italy

Site Status

GSK Investigational Site

Rome, Lazio, Italy

Site Status

GSK Investigational Site

Rozzano (MI), Lombardy, Italy

Site Status

GSK Investigational Site

Cagliari, Sardinia, Italy

Site Status

GSK Investigational Site

Palermo, Sicily, Italy

Site Status

GSK Investigational Site

Torrette (AN), The Marches, Italy

Site Status

GSK Investigational Site

Florence, Tuscany, Italy

Site Status

GSK Investigational Site

Padua, Veneto, Italy

Site Status

GSK Investigational Site

Benoni, Gauteng, South Africa

Site Status

GSK Investigational Site

Bellville, , South Africa

Site Status

GSK Investigational Site

Bloemfontein, , South Africa

Site Status

GSK Investigational Site

Cape Town, , South Africa

Site Status

GSK Investigational Site

George, , South Africa

Site Status

GSK Investigational Site

Port Elizabeth, , South Africa

Site Status

GSK Investigational Site

Reiger Park, , South Africa

Site Status

GSK Investigational Site

Somerset West, , South Africa

Site Status

GSK Investigational Site

Thabazimbi, , South Africa

Site Status

GSK Investigational Site

Witbank, , South Africa

Site Status

GSK Investigational Site

Alicante, , Spain

Site Status

GSK Investigational Site

Córdoba, , Spain

Site Status

GSK Investigational Site

Lugo, , Spain

Site Status

GSK Investigational Site

Mérida (Badajoz), , Spain

Site Status

GSK Investigational Site

Ponferrada (León), , Spain

Site Status

GSK Investigational Site

Valladolid, , Spain

Site Status

GSK Investigational Site

Cherkassy, , Ukraine

Site Status

GSK Investigational Site

Donetsk, , Ukraine

Site Status

GSK Investigational Site

Kharkiv, , Ukraine

Site Status

GSK Investigational Site

Kharkiv, , Ukraine

Site Status

GSK Investigational Site

Kiev, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Mykolayiv, , Ukraine

Site Status

GSK Investigational Site

Vinnytsia, , Ukraine

Site Status

Countries

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United States Germany Italy South Africa Spain Ukraine

References

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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

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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112352

Identifier Type: -

Identifier Source: org_study_id

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