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Pulmonary Disease, Chronic ObstructivePhase 3NCT01342913

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))

A Phase 3 study testing Fluticasone Furoate 100mcg/Vilanterol 25mcg and Fluticaosne Propionate 500mcg/Salmeterol 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 66 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Fluticasone Furoate 100mcg/Vilanterol 25mcg and Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
528 participants
Where
66 sitesin 9 countries
Study dates
1 Feb 2011to 19 Oct 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

66 sites in 9 countries.

66 sites in 9 countries

Germany13 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 10789

  • GSK Investigational Site

    Berlin, 14057

  • GSK Investigational Site

    Delitzsch, Saxony, 04509

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Hamburg, 20253

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Leipzig, Saxony, 04207

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Munich, Bavaria, 80809

Other trials in Germany

Italy9 sites

  • GSK Investigational Site

    Acquaviva Delle Fonti BA, Apulia, 70021

  • GSK Investigational Site

    Benevento, Campania, 82100

  • GSK Investigational Site

    Cittadella PD, Veneto, 35013

  • GSK Investigational Site

    Perugia, Umbria, 06156

  • GSK Investigational Site

    Pisa, Tuscany, 56124

  • GSK Investigational Site

    Rome, Lazio, 00135

  • GSK Investigational Site

    Salerno, Campania, 84100

  • GSK Investigational Site

    Sesto S. Giovanni MI, Lombardy, 20099

  • GSK Investigational Site

    Verona, Veneto, 37134

Other trials in Italy

Belgium7 sites

  • GSK Investigational Site

    Bouge, 5004

  • GSK Investigational Site

    Brussels, 1070

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Genk, 3600

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Gilly, 6060

Other trials in Belgium

France7 sites

  • GSK Investigational Site

    Béthune, 62408

  • GSK Investigational Site

    Brest, 29609

  • GSK Investigational Site

    Lille, 59000

  • GSK Investigational Site

    Marseille, 13915

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Nice, 06002

  • GSK Investigational Site

    Pessac, 33604

Other trials in France

Poland7 sites

  • GSK Investigational Site

    Bialystok

  • GSK Investigational Site

    Częstochowa, 42-200

  • GSK Investigational Site

    Lodz, 92-107

  • GSK Investigational Site

    Lodz, 93-329

  • GSK Investigational Site

    Ostrów Wielkopolski, 63-400

  • GSK Investigational Site

    Piekary Śląskie, 41-940

  • GSK Investigational Site

    Wilkowice, 43-365

Other trials in Poland

Russia7 sites

  • GSK Investigational Site

    Chelyabinsk, 454034

  • GSK Investigational Site

    Kazan', 420015

  • GSK Investigational Site

    Kemerovo, 650000

  • GSK Investigational Site

    Moscow, 115093

  • GSK Investigational Site

    Moscow, 115446

  • GSK Investigational Site

    Moscow, 125367

  • GSK Investigational Site

    Yaroslavl, 150003

Other trials in Russia

Spain7 sites

  • GSK Investigational Site

    Alicante, 03114

  • GSK Investigational Site

    Barakaldo (Vizcaya), 48903

  • GSK Investigational Site

    Cáceres, 10003

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

  • GSK Investigational Site

    San Sebastián, 20014

  • GSK Investigational Site

    Valencia, 46015

Other trials in Spain

Ukraine5 sites

  • GSK Investigational Site

    Cherkassy, 18009

  • GSK Investigational Site

    Ivano-Frankivsk, 76018

  • GSK Investigational Site

    Kharkiv, 61035

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kyiv, 04107

Other trials in Ukraine

Philippines4 sites

  • GSK Investigational Site

    Jaro, Iloilo City, 5000

  • GSK Investigational Site

    Lipa City, 4217

  • GSK Investigational Site

    Quezon City, 1100

  • GSK Investigational Site

    Quezon City, 1101

Other trials in Philippines

About this study

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)

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.

Read the detailed 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.

Being tested
Fluticasone Furoate 100mcg/Vilanterol 25mcg, Fluticaosne Propionate 500mcg/Salmeterol 50mcg
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluticasone Furoate 100mcg/Vilanterol 25mcgDrug

    Inhalation Powder

  • Fluticaosne Propionate 500mcg/Salmeterol 50mcgDrug

    Inhalation Powder

Study groups in NCT01342913
Study groupRoleWhat they receive
Fluticasone Furoate/VilanterolExperimentalInhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA)
Receives: Drug: Fluticasone Furoate 100mcg/Vilanterol 25mcg
Fluticasone Propionate/SalmeterolActive comparatorInhaled Corticosteroid (ICS)/Long Acting Beta Agonist (LABA
Receives: Drug: Fluticaosne Propionate 500mcg/Salmeterol 50mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Day 84

Secondary outcomes (2)

  1. 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.

    Measured: Day 1

  2. 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.

    Measured: Baseline and Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2011 (estimated)
  2. Study start1 Feb 2011
  3. Primary completion1 Oct 2011
  4. Study completion19 Oct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
528 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01342913
Sponsor's protocol ID
113107
Status last verified
Aug 2018
First submitted
14 Apr 2011
Last updated
31 Aug 2018
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Agusti A, de Teresa L, De Backer W, Zvarich MT, Locantore N, Barnes N, Bourbeau J, Crim C. A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD. Eur Respir J. 2014 Mar;43(3):763-72. doi: 10.1183/09031936.00054213. Epub 2013 Oct 10.

    PubMed 24114969

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone Furoate 100mcg/Vilanterol 25mcg and Fluticaosne Propionate 500mcg/Salmeterol 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 66 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Germany, Italy, Belgium, France, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84 (time frame: Baseline and Day 84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01342913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.

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