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Pulmonary Disease, Chronic ObstructivePhase 3NCT01323621

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)

A Phase 3 study testing Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg, Fluticasone Propionate 250mcg / salmeterol 50mcg and Salbutamol as needed in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 51 sites in 6 countries.

Completed

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

Official record
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Trial summary

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. 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/ GW642444 (vilanterol) 25mcg, Fluticasone Propionate 250mcg / salmeterol 50mcg and Salbutamol as needed
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
512 participants
Where
51 sitesin 6 countries
Study dates
18 Mar 2011to 24 Jan 2012
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)

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 19Show 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

51 sites in 6 countries.

51 sites in 6 countries

United States13 sites

  • GSK Investigational Site

    Boerne, Texas, 78006

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Jasper, Alabama, 35501

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Minneapolis, Minnesota, 55402

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Orangeburg, South Carolina, 29118

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Seneca, South Carolina, 29678

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

Other trials in United States

Italy11 sites

  • GSK Investigational Site

    Cagliari, Sardinia, 09126

  • GSK Investigational Site

    Florence, Tuscany, 50134

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Padova, Veneto, 35128

  • GSK Investigational Site

    Palermo, Sicily, 90146

  • GSK Investigational Site

    Parma, Emilia-Romagna, 43100

  • GSK Investigational Site

    Rome, Lazio, 00185

  • GSK Investigational Site

    Rozzano (MI), Lombardy, 20089

  • GSK Investigational Site

    San Felice A Cancello Caserta, Campania, 81027

  • GSK Investigational Site

    Telese Terme (BN), Campania, 82037

  • GSK Investigational Site

    Torrette (AN), The Marches, 60126

Other trials in Italy

South Africa10 sites

  • GSK Investigational Site

    Bellville, 7531

  • GSK Investigational Site

    Benoni, Gauteng, 1501

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Cape Town, 7572

  • GSK Investigational Site

    George, 6529

  • GSK Investigational Site

    Port Elizabeth, 6045

  • GSK Investigational Site

    Reiger Park, 1459

  • GSK Investigational Site

    Somerset West, 7130

  • GSK Investigational Site

    Thabazimbi, 0380

  • GSK Investigational Site

    Witbank, 1034

Other trials in South Africa

Ukraine10 sites

  • GSK Investigational Site

    Cherkassy, 18009

  • GSK Investigational Site

    Donetsk, 83099

  • GSK Investigational Site

    Kharkiv, 61002

  • GSK Investigational Site

    Kharkiv, 61035

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kyiv, 03038

  • GSK Investigational Site

    Kyiv, 03049

  • GSK Investigational Site

    Kyiv, 04107

  • GSK Investigational Site

    Mykolayiv, 54003

  • GSK Investigational Site

    Vinnytsia, 21018

Other trials in Ukraine

Spain6 sites

  • GSK Investigational Site

    Alicante, 03114

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Lugo, 27003

  • GSK Investigational Site

    Mérida (Badajoz), 06800

  • GSK Investigational Site

    Ponferrada (León), 24411

  • GSK Investigational Site

    Valladolid, 47005

Other trials in Spain

Germany1 site

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

Other trials in Germany

About this study

Official title: A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg 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 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.

Read the detailed description

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.

Being tested
Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg, Fluticasone Propionate 250mcg / salmeterol 50mcg, Double-dummy placebo, Salbutamol as needed
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/ GW642444 (vilanterol) 25mcgDrug

    inhalation powder

  • Fluticasone Propionate 250mcg / salmeterol 50mcgDrug

    inhalation powder

  • Double-dummy placeboDrug

    inhalation powder

  • Salbutamol as neededDrug

    inhalation powder

Study groups in NCT01323621
Study groupRoleWhat they receive
Fluticasone Furoate / GW642444 (vilanterol)ExperimentalInhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
Receives: Drug: Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg; Drug: Double-dummy placebo; Drug: Salbutamol as needed
Fluticasone Propionate / salmeterolActive comparatorInhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
Receives: Drug: Fluticasone Propionate 250mcg / salmeterol 50mcg; Drug: Double-dummy placebo; Drug: Salbutamol as needed

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), defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the 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 post-dose on Treatment Day 84. Baseline trough FEV1 was calculated as 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. Analysis of covariance (ANCOVA) was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.

    Measured: Baseline (Day 1) and Day 84

Secondary outcomes (1)

  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 to onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.

    Measured: Baseline and Day 1

Timeline

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

  1. First posted25 Mar 2011 (estimated)
  2. Study start18 Mar 2011
  3. Primary completion1 Jan 2012
  4. Study completion24 Jan 2012

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
512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01323621
Sponsor's protocol ID
112352
Status last verified
Jan 2018
First submitted
17 Mar 2011
Last updated
15 Feb 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

  • 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.

    PubMed 24998880

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg, Fluticasone Propionate 250mcg / salmeterol 50mcg and Salbutamol as needed in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 51 sites in 6 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 6 inclusion and 19 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 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Italy, South Africa, Ukraine, Spain and 1 more country. 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 6 Feb 2014). 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 (Day 1) 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 NCT01323621, 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 15 Feb 2018.

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Clinical Trial NCT01323621 | AzTrials