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Pulmonary Disease, Chronic ObstructivePhase 3NCT01627327

Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease

A Phase 3 study testing fluticasone furoate/vilanterol 100/25mcg and tiotropium bromide 18mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 54 sites in 6 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 Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid… 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/vilanterol 100/25mcg and tiotropium bromide 18mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
623 participants
Where
54 sitesin 6 countries
Study dates
1 Apr 2012to 21 Dec 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
  • Females must be post-menopausal or using a highly effective method for avoidance of pregnancy
  • Established clinical history of COPD by ATS/ERS definition
  • Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≥30 to ≤ 70% of predicted normal (NHANES III)
  • Former or current smoker ≥10 pack years
Show all 17Show fewer
  • A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following:
  • Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD)
  • Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD)
  • Previous stroke
  • Objectively confirmed transient ischemic attack (TIA) (i.e., transient neurological deficit documented by a health-care professional)
  • Previous myocardial infarction (MI) (Note: An MI within 6 months prior to Visit 1 is exclusionary)
  • OR
  • Presence of one of the following cardiovascular risk factors (in addition to being a former/current smoker):
  • Current diagnosis of hypertension
  • Current diagnosis of hypercholesterolemia
  • Diabetes mellitus treated with pharmacotherapy

Who cannot join

  • Current diagnosis of asthma
  • Subjects with other respiratory disorders including α1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), 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 or CT scan
  • 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 25Show fewer
  • Lower respiratory infection requiring antibiotics 6 weeks prior to Screening
  • A moderate or severe COPD exacerbation and/or a lower respiratory tract infection (including pnuemonia) during the Run-In Period
  • An abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization
  • An abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization
  • An abnormal, clinically significant Holter finding at Screening (Visit 1) or upon repeat prior to randomization (sub-set of subjects)
  • Historical or current evidence of clinically significant (in opinion of the Investigator) and unstable disease such as cardiovascular (e.g., patients requiring ICD, pacemaker requiring a ventricular pace rate set at >60 bpm, uncontrolled hypertension, New York Heart Association Class IV (New York Heart Association,1994), known left ventricular ejection fraction <30%), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities
  • Carcinoma not in complete remission for at least 5 years
  • History of allergy or hypersensitivity to any of the study medications (e.g., anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate) or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subject's participation will also be excluded
  • 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 /salbutamol for 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
  • Failure to demonstrate adequate compliance defined as completion of the Diary Card (completed all diary entries on at least 4 of the last 7 consecutive days), the ability to withhold COPD medications and to keep clinic visit appointments
  • Non-compliance or inability to comply with study procedures or scheduled visits
  • History of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
  • Affiliation with investigator site
  • Women who are pregnant or lactating or are planning on becoming pregnant during the study

Trial locations and contacts

54 sites in 6 countries.

54 sites in 6 countries

Germany13 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 10789

  • GSK Investigational Site

    Cottbus, Brandenburg, 03050

  • GSK Investigational Site

    Dresden, Saxony, 01069

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Großhansdorf, Schleswig-Holstein, 22927

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

  • GSK Investigational Site

    Schwerin, Mecklenburg-Vorpommern, 19055

Other trials in Germany

United States11 sites

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Medford, Oregon, 97404

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Newport News, Virginia, 23606

  • GSK Investigational Site

    Seneca, South Carolina, 29678

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Union, South Carolina, 29379

Other trials in United States

Canada9 sites

  • GSK Investigational Site

    Montreal, Quebec, H2W 1T8

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

  • GSK Investigational Site

    Montreal, Quebec, H4N 3C5

  • GSK Investigational Site

    Saint Romuald, Quebec, G6W 5M6

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 1Z1

  • GSK Investigational Site

    Toronto, Ontario, M5V 2T3

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Romania9 sites

  • GSK Investigational Site

    Bucharest, 020125

  • GSK Investigational Site

    Bucharest, 030317

  • GSK Investigational Site

    Bucharest, 050159

  • GSK Investigational Site

    Bucharest, 70000

  • GSK Investigational Site

    Cluj-Napoca, 400371

  • GSK Investigational Site

    Constanța, 900002

  • GSK Investigational Site

    Iași, 700115

  • GSK Investigational Site

    Suceava, 720284

  • GSK Investigational Site

    Timișoara, 300310

Other trials in Romania

Poland7 sites

  • GSK Investigational Site

    Bialystok

  • GSK Investigational Site

    Częstochowa, 42-200

  • GSK Investigational Site

    Działdowo, 13-200

  • GSK Investigational Site

    Krakow, 31-024

  • GSK Investigational Site

    Piekary Śląskie, 41-940

  • GSK Investigational Site

    Słupsk, 76-200

  • GSK Investigational Site

    Tarnów, 33-100

Other trials in Poland

Czechia5 sites

  • GSK Investigational Site

    Kralupy nad Vltavou, 278 01

  • GSK Investigational Site

    Kroměříž, 767 55

  • GSK Investigational Site

    Teplice, 415 10

  • GSK Investigational Site

    Třebíč, 674 01

  • GSK Investigational Site

    Žamberk, 564 01

Other trials in Czechia

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 100/25mcg Once-Daily Via a Novel Dry Powder Inhaler Compared With Tiotropium Bromide Inhalation Powder 18mcg Delivered Once-Daily Via the HandiHaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Who Have or Are at Risk for Co-morbid Cardiovascular Disease

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease

Read the detailed description

This is a randomized, double-blind, double-dummy, multi-center, parallel-group study. Subjects who meet the eligibility criteria at Screening and 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/vilanterol 100/25mcg, tiotropium bromide 18mcg
Keywords
Cardiovascular event, Cardiovascular disease
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases

What participants receive

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

  • fluticasone furoate/vilanterol 100/25mcgDrug

    inhalation powder

  • tiotropium bromide 18mcgDrug

    Also called Spiriva

    inhalation powder

Study groups in NCT01627327
Study groupRoleWhat they receive
fluticasone furoate/vilanterolExperimentalinhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA)
Receives: Drug: fluticasone furoate/vilanterol 100/25mcg
tiotropium bromideActive comparatoranticholinergic
Receives: Drug: tiotropium bromide 18mcg

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 from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 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 (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.

    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 minutes (min), 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. Time to onset was analyzed using a log-rank test, stratified by exacerbation history and reversibility stratum.

    Measured: Baseline and Day 1

  2. Change From Baseline in Trough FEV1 at Treatment Day 84

    Pulmonary function was measured by FEV1. Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 84. 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 84 values minus the Baseline value. Analysis was performed using an ANCOVA model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.

    Measured: Baseline and Day 84

Timeline

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

  1. First posted25 Jun 2012 (estimated)
  2. Study start1 Apr 2012
  3. Primary completion1 Dec 2012
  4. Study completion21 Dec 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
623 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01627327
Sponsor's protocol ID
115805
Status last verified
Oct 2017
First submitted
21 Jun 2012
Last updated
9 Nov 2017
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fluticasone furoate/vilanterol 100/25mcg and tiotropium bromide 18mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 54 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 17 inclusion and 25 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 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Germany, United States, Canada, Romania, Poland 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 1 Nov 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 NCT01627327.

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 9 Nov 2017; AzTrials last refreshed its copy on 27 Oct 2026.

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