A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A 12-week Study to Evaluate the 24 Hour Pulmonary Function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared With Salmeterol/Fluticasone Propionate (FP) Inhalation Powder Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342913
• Other study ID #: 113107
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2011
• Est. completion date: October 19, 2011

Study information

• Verified date: August 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.

Description:

This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligilibilty 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: October 19, 2011
• Est. primary completion date: October 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

• have been hospitalised or have been treated with oral corticosteroids or antibiotics for their COPD within the last 3 years prior to Screening (Visit 1)

Exclusion Criteria:

• Current diagnosis of asthma

• Subjects with other respiratory disorders including active tuberculosis, a1-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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Drug:
• Fluticasone Furoate 100mcg/Vilanterol 25mcg
Inhalation Powder
• Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Inhalation Powder

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Bouge
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Edegem
Belgium	GSK Investigational Site	Genk
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Gilly
France	GSK Investigational Site	Bethune Cedex
France	GSK Investigational Site	Brest Cedex
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Marseille Cedex 20
France	GSK Investigational Site	Montpellier cedex 5
France	GSK Investigational Site	Nice
France	GSK Investigational Site	Pessac cedex
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Delitzsch	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt am Main	Hessen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Muenchen	Bayern
Italy	GSK Investigational Site	Acquaviva Delle Fonti BA	Puglia
Italy	GSK Investigational Site	Benevento	Campania
Italy	GSK Investigational Site	Cittadella PD	Veneto
Italy	GSK Investigational Site	Perugia	Umbria
Italy	GSK Investigational Site	Pisa	Toscana
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Salerno	Campania
Italy	GSK Investigational Site	Sesto S. Giovanni MI	Lombardia
Italy	GSK Investigational Site	Verona	Veneto
Philippines	GSK Investigational Site	Jaro, Iloilo City
Philippines	GSK Investigational Site	Lipa City
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Quezon City
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Czestochowa
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Ostrow Wielkopolski
Poland	GSK Investigational Site	Piekary Slaskie
Poland	GSK Investigational Site	Wilkowice
Russian Federation	GSK Investigational Site	Chelyabinsk
Russian Federation	GSK Investigational Site	Kazan
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Yaroslavl
Spain	GSK Investigational Site	Alicante
Spain	GSK Investigational Site	Barakaldo (Vizcaya)
Spain	GSK Investigational Site	Cáceres
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Pozuelo De Alarcón/Madrid
Spain	GSK Investigational Site	San Sebastián
Spain	GSK Investigational Site	Valencia
Ukraine	GSK Investigational Site	Cherkassy
Ukraine	GSK Investigational Site	Ivano-Frankivsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kiev
Ukraine	GSK Investigational Site	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Philippines,  Poland,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84	Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.	Baseline and Day 84
Secondary	Time to Onset on Treatment Day 1	Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.	Day 1
Secondary	Change From Baseline in Trough FEV1 on Treatment Day 85	Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value.	Baseline and Day 85

External Links

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