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Pulmonary Disease, Chronic ObstructivePhase 3NCT01053988

A 6-month Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing FF/GW642444 Inhalation Powder, FF Inhalation Powder and GW642444 Inhalation Powder in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 132 sites in 10 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 assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subjects with chronic obstructive pulmonary disease (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?
FF/GW642444 Inhalation Powder, FF Inhalation Powder and GW642444 Inhalation Powder
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,031 participants
Where
132 sitesin 10 countries
Study dates
5 Oct 2009to 14 Apr 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

  • Type of subject: outpatient
  • Informed consent: Subjects must give their signed and dated written informed consent to participate.
  • Gender: Male or female subjects A female is eligible to enter and participate in the study if she is of:
  • Non-child bearing potential OR
  • Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods defined in the protocol
  • Age: ≥40 years of age at Screening (Visit 1)
Show all 12Show fewer
  • COPD diagnosis: Subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]
  • Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening (Visit 1).
  • Severity of Disease: Subjects with a Screening (Visit 1) measured post-albuterol/salbutamol:
  • FEV1/FVC ratio of ≤0.70 and
  • FEV1 ≤70% of predicted normal values
  • Dyspnea: Achieved a score of ≥2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Screening (Visit 1).

Who cannot join

  • Subjects meeting any of the following criteria must not be enrolled in the study:
  • Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
  • Asthma: Subjects with a current diagnosis of asthma
  • α1-antitrypsin deficiency: Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
  • Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases
  • Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1)
Show all 25Show fewer
  • Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD.
  • Hospitalization: Subjects who are hospitalized due to poorly controlled COPD within 12 weeks of Visit 1.
  • Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of the following in the 6 weeks prior to Visit 1: Acute worsening of COPD that is managed by subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician.
  • Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1.
  • Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
  • Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
  • Hypertension: Subjects with clinically significant hypertension that is uncontrolled.
  • Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
  • Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medication or components of the inhalation powder
  • Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
  • Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol and/or their ipratropium 4 hours prior to spirometry testing at each study visit
  • Additional medication: Use of certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications)
  • Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., ≤12 hours per day) is not exclusionary.
  • Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
  • Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study.
  • Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
  • Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
  • Prior use of study medication/other investigational drugs
  • Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.

Trial locations and contacts

132 sites in 10 countries.

132 sites in 10 countries

United States47 sites

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Austell, Georgia, 30106

  • GSK Investigational Site

    Baltimore, Maryland, 21224

  • GSK Investigational Site

    Charleston, South Carolina, 29406-7108

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Clearwater, Florida, 33755

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Edina, Minnesota, 55438

  • GSK Investigational Site

    Encinitas, California, 92024

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Fall River, Massachusetts, 02720

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Hazard, Kentucky, 41701

  • GSK Investigational Site

    Livonia, Michigan, 48152

  • GSK Investigational Site

    Madisonville, Kentucky, 42431

  • GSK Investigational Site

    Maitland, Florida, 32751

  • GSK Investigational Site

    Marietta, Georgia, 30060

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Miami, Florida, 33125

  • GSK Investigational Site

    Minneapolis, Minnesota, 55407

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Montgomery, Alabama, 36106

  • GSK Investigational Site

    New Orleans, Louisiana, 70115

  • GSK Investigational Site

    Orlando, Florida, 32822

  • GSK Investigational Site

    Panama City, Florida, 32405

  • GSK Investigational Site

    Pelzer, South Carolina, 29669

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Rancho Mirage, California, 92270

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92117

  • GSK Investigational Site

    Scottsdale, Arizona, 85258

  • GSK Investigational Site

    Sepulveda, California, 91343

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St Louis, Missouri, 63117

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Stockbridge, Georgia, 30281

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Tamarac, Florida, 33321

  • GSK Investigational Site

    Wichita, Kansas, 67205

  • GSK Investigational Site

    Wichita, Kansas, 67207

  • GSK Investigational Site

    Wichita Falls, Texas, 76309

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

  • GSK Investigational Site

    Winter Park, Florida, 32789

Other trials in United States

Germany22 sites

  • GSK Investigational Site

    Aschaffenburg, Bavaria, 63739

  • GSK Investigational Site

    Deggingen, Baden-Wurttemberg, 73326

  • GSK Investigational Site

    Dortmund, North Rhine-Westphalia, 44263

  • GSK Investigational Site

    Erlangen, Bavaria, 91052

  • GSK Investigational Site

    Eschwege, Hesse, 37269

  • GSK Investigational Site

    Gelsenkirchen, North Rhine-Westphalia, 45879

  • GSK Investigational Site

    Görlitz, Saxony, 02826

  • GSK Investigational Site

    Hamburg, 20253

  • GSK Investigational Site

    Hamburg, 20354

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Hanover, Lower Saxony, 30167

  • GSK Investigational Site

    Kassel, Hesse, 34121

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Munich, Bavaria, 80802

  • GSK Investigational Site

    Munich, Bavaria, 80809

  • GSK Investigational Site

    Rüdersdorf, Brandenburg, 15562

  • GSK Investigational Site

    Rüsselsheim am Main, Hesse, 65428

  • GSK Investigational Site

    Schmölln, Thuringia, 04626

  • GSK Investigational Site

    Schwetzingen, Baden-Wurttemberg, 68723

Other trials in Germany

Poland13 sites

  • GSK Investigational Site

    Bialystok, 15-084

  • GSK Investigational Site

    Bialystok, 15-540

  • GSK Investigational Site

    Gdansk, 80-405

  • GSK Investigational Site

    Grudziądz, 86-300

  • GSK Investigational Site

    Krakow, 31-023

  • GSK Investigational Site

    Lodz, 93-329

  • GSK Investigational Site

    Lodz, 93-504

  • GSK Investigational Site

    Lublin, 20-954

  • GSK Investigational Site

    Ostrów Wielkopolski, 63-400

  • GSK Investigational Site

    Poznan, 60-569

  • GSK Investigational Site

    Wilkowice, 43-365

  • GSK Investigational Site

    Wodzisław Śląski, 44-300

  • GSK Investigational Site

    Zabrze, 41-800

Other trials in Poland

Russia11 sites

  • GSK Investigational Site

    Barnaul, 656 045

  • GSK Investigational Site

    Irkutsk, 664005

  • GSK Investigational Site

    Moscow, 119620

  • GSK Investigational Site

    Pyatigorsk, 357538

  • GSK Investigational Site

    Samara, 443079

  • GSK Investigational Site

    Shakhty, Rostov Region, 346510

  • GSK Investigational Site

    Tomsk, 634001

  • GSK Investigational Site

    Tyumen, 625023

  • GSK Investigational Site

    Ufa, 450071

  • GSK Investigational Site

    Yaroslavl, 150062

  • GSK Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

Japan10 sites

  • GSK Investigational Site

    Fukuoka, 815-8588

  • GSK Investigational Site

    Fukuoka, 832-0059

  • GSK Investigational Site

    Ibaraki, 319-1113

  • GSK Investigational Site

    Kagawa, 762-0031

  • GSK Investigational Site

    Kanagawa, 232-0066

  • GSK Investigational Site

    Nagano, 382-0091

  • GSK Investigational Site

    Osaka, 596-8501

  • GSK Investigational Site

    Shizuoka, 438-8550

  • GSK Investigational Site

    Tokyo, 145-0063

  • GSK Investigational Site

    Tokyo, 187-0031

Other trials in Japan

South Korea10 sites

  • GSK Investigational Site

    Bucheon-si, 420-767

  • GSK Investigational Site

    Daegu, 705-717

  • GSK Investigational Site

    Gyeonggi-do, 431-070

  • GSK Investigational Site

    Incheon, 405-760

  • GSK Investigational Site

    Kangwon-do, 220-701

  • GSK Investigational Site

    Seoul, 130-848

  • GSK Investigational Site

    Seoul, 136-705

  • GSK Investigational Site

    Seoul, 143-729

  • GSK Investigational Site

    Seoul, 152-703

  • GSK Investigational Site

    Uijeongbu-si, Kyonggi-do, 480-130

Other trials in South Korea

Chile5 sites

  • GSK Investigational Site

    Puente Alto - Santiago, Región Metro de Santiago, 8207257

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500691

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7601003

  • GSK Investigational Site

    Santiago, 8380453

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

Other trials in Chile

Mexico5 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44100

  • GSK Investigational Site

    Mexico City, 07760

  • GSK Investigational Site

    Monterrey, Nuevo León, 64060

  • GSK Investigational Site

    Monterrey, Nuevo León, 64460

  • GSK Investigational Site

    Monterrey NL, Nuevo León, 64718

Other trials in Mexico

Philippines5 sites

  • GSK Investigational Site

    Iloilo City, 5000

  • GSK Investigational Site

    Lipa City, 4217

  • GSK Investigational Site

    Pasig, 1600

  • GSK Investigational Site

    Quezon City, 1100

  • GSK Investigational Site

    Quezon City, 1101

Other trials in Philippines

Estonia4 sites

  • GSK Investigational Site

    Pärnu, 80010

  • GSK Investigational Site

    Tallinn, 10138

  • GSK Investigational Site

    Tallinn, 13619

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

About this study

Official title: A 24-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Compared With Placebo in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subjects with chronic obstructive pulmonary disease (COPD)

Being tested
FF/GW642444 Inhalation Powder, FF Inhalation Powder, GW642444 Inhalation Powder, Placebo
Keywords
Safety, Chronic Obstructive Pulmonary Disease, Efficacy, FEV1, COPD
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.

  • FF/GW642444 Inhalation PowderDrug

    Also called FF Inhalation Powder, Placebo, GW642444 Inhalation Powder

    Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD

  • FF Inhalation PowderDrug

    Inhaled Corticosteroid (ICS)

  • GW642444 Inhalation PowderDrug

    Long Acting Beta Agonist(LABA)

  • PlaceboDrug

    Placebo

Study groups in NCT01053988
Study groupRoleWhat they receive
FF/GW642444 Inhalation PowderExperimentalInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Receives: Drug: FF/GW642444 Inhalation Powder
FF Inhalation PowderExperimentalInhaled Corticosteroid (ICS)
Receives: Drug: FF Inhalation Powder
GW642444 Inhalation PowderExperimentalLong Acting Beta Agonist(LABA)
Receives: Drug: GW642444 Inhalation Powder
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo
FF/GW642444 Inhalation PwdrExperimentalInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Receives: Drug: FF/GW642444 Inhalation Powder

What is being measured

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

  1. Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168

    Co-Primary Endpoint: 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. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.

    Measured: Baseline (BL) to Day 168

  2. Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169

    Co-Primary Endpoint: 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. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.

    Measured: Baseline to Day 169

Secondary outcomes (3)

  1. Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168

    Considered an 'Other' endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.

    Measured: Baseline to Day 168

  2. Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1

    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. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.

    Measured: Baseline and Day 1

  3. Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1

    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. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.

    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 posted22 Jan 2010 (estimated)
  2. Study start5 Oct 2009
  3. Primary completion1 Feb 2011
  4. Study completion14 Apr 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
1,031 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01053988
Sponsor's protocol ID
112206
Status last verified
Jun 2018
First submitted
14 Jan 2010
Last updated
12 Jul 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

  • Kerwin EM, Scott-Wilson C, Sanford L, Rennard S, Agusti A, Barnes N, Crim C. A randomised trial of fluticasone furoate/vilanterol (50/25 mug; 100/25 mug) on lung function in COPD. Respir Med. 2013 Apr;107(4):560-9. doi: 10.1016/j.rmed.2012.12.014. Epub 2013 Jan 23.

    PubMed 23352226

  • Yang L, Llanos-Paez C, Yang S, Ambery C, Berges A, Kjellsson MC, Karlsson MO. A Combined Model-Based Meta-Analysis of Aggregated and Individual FEV1 Data From Randomized COPD Trials. CPT Pharmacometrics Syst Pharmacol. 2026 Feb;15(2):e70059. doi: 10.1002/psp4.70059. Epub 2025 Jun 19.

    PubMed 40536286

  • Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.

    PubMed 24314123

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FF/GW642444 Inhalation Powder, FF Inhalation Powder and GW642444 Inhalation Powder in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 132 sites in 10 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 12 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 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, Germany, Poland, Russia, Japan and 5 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. Some participants in this study may receive a placebo. 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 15 Aug 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 in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168 (time frame: Baseline (BL) to Day 168). The study lists 2 primary outcomes in all. 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 NCT01053988, which also lists 3 linked publications.

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 12 Jul 2018.

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