AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 3DB2113373NCT01313650

A 24-week Evaluation of GSK573719/Vilanterol (62.5/25mcg) and Components in COPD

A Phase 3 study testing 62.5/25mcg, 62.5mcg and 25mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 165 sites in 13 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

This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week… 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?
62.5/25mcg, 62.5mcg and 25mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,538 participants
Where
165 sitesin 13 countries
Study dates
1 Mar 2011to 5 Apr 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

  • Diagnosis of COPD
  • 10 pack-year or greater history of cigarette smoking
  • Post-bronchodilator FEV1/FVC of <0.7
  • Predicted FEV1 of 70% of normal or less
  • Modified Medical Research Council (mMRC) dyspnea score of 2 or greater

Who cannot join

  • Women who are pregnant, lactating, or planning to become pregnant
  • Respiratory disorders other than COPD, including a current diagnosis of asthma
  • Clinically significant non-respiratory diseases or abnormalities that are not adequate controlled
  • Significant allergy or hypersensitivity to anticholinergics, beta-agonist, or the excipients of magnesium stereate or lactose used in the inhaler delivery device
  • Hospitalization for COPD or pneumonia within 12 weeks prior to screening
  • Lung volume reduction surgery within 12 weeks prior to screening
Show all 15Show fewer
  • Abnormal and clinically significant ECG findings at screening
  • Clinically significant laboratory findings at screening
  • Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong cytochrome P450 3A4 inhibitors, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit
  • Use of long-term oxygen therapy (12 hours or greater per day)
  • Regular use of nebulized treatment with short-acting bronchodilators
  • Participation in the acute phase of a pulmonary rehabilitation program
  • A know or suspected history of alcohol or drug abuse
  • Affiliation with the investigational site
  • Previous use of GSK573719 or GW642444 alone or in combination, including the combination of fluticasone furoate and GW64244

Trial locations and contacts

165 sites in 13 countries.

165 sites in 13 countries

United States37 sites

  • GSK Investigational Site

    Abingdon, Virginia, 24210

  • GSK Investigational Site

    Albuquerque, New Mexico, 87108

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Beaver, Pennsylvania, 15009

  • GSK Investigational Site

    Cadillac, Michigan, 49601

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Cincinnati, Ohio, 45245

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    Dayton, Ohio, 45459

  • GSK Investigational Site

    Erie, Pennsylvania, 16508

  • GSK Investigational Site

    Gaffney, South Carolina, 29340

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Johnson City, Tennessee, 37601

  • GSK Investigational Site

    Kingwood, Texas, 77339

  • GSK Investigational Site

    Lafayette, Indiana, 47904

  • GSK Investigational Site

    Larchmont, New York, 10538

  • GSK Investigational Site

    Lawrenceville, Georgia, 30046

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Madisonville, Kentucky, 42431

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    New Orleans, Louisiana, 70115

  • GSK Investigational Site

    Newport News, Virginia, 23606

  • GSK Investigational Site

    Olathe, Kansas, 66061

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Ormond Beach, Florida, 32174

  • GSK Investigational Site

    Pelzer, South Carolina, 29669

  • GSK Investigational Site

    Phoenixville, Pennsylvania, 19460

  • GSK Investigational Site

    Rapid City, South Dakota, 57702

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Sunset, Louisiana, 70584

  • GSK Investigational Site

    Tampa, Florida, 33603

  • GSK Investigational Site

    Topeka, Kansas, 66606

  • GSK Investigational Site

    Tucson, Arizona, 85723

Other trials in United States

Russia17 sites

  • GSK Investigational Site

    Arkhangelsk, 153000

  • GSK Investigational Site

    Barnaul, 656 045

  • GSK Investigational Site

    Blagoveshchensk, 675000

  • GSK Investigational Site

    Krasnoyarsk, 660022

  • GSK Investigational Site

    Moscow, 105 229

  • GSK Investigational Site

    Moscow, 119620

  • GSK Investigational Site

    Moscow, 123182

  • GSK Investigational Site

    Nizhny Novgorod, 603126

  • GSK Investigational Site

    Novosibirsk, 630087

  • GSK Investigational Site

    Perm, 614077

  • GSK Investigational Site

    Pyatigorsk, 357538

  • GSK Investigational Site

    Saint Petersburg, 194354

  • GSK Investigational Site

    Saint Petersburg, 198260

  • GSK Investigational Site

    Saratov, 410028

  • GSK Investigational Site

    Tomsk, 634063

  • GSK Investigational Site

    Ufa, 450071

  • GSK Investigational Site

    Yaroslavl, 150062

Other trials in Russia

Japan16 sites

  • GSK Investigational Site

    Fukushima, 963-8052

  • GSK Investigational Site

    Hyōgo, 672-8064

  • GSK Investigational Site

    Ibaraki, 311-3193

  • GSK Investigational Site

    Ibaraki, 312-0057

  • GSK Investigational Site

    Kanagawa, 254-8502

  • GSK Investigational Site

    Kumamoto, 861-1196

  • GSK Investigational Site

    Kyoto, 602-8026

  • GSK Investigational Site

    Osaka, 530-0001

  • GSK Investigational Site

    Osaka, 558-8558

  • GSK Investigational Site

    Saitama, 343-8555

  • GSK Investigational Site

    Shimane, 690-8506

  • GSK Investigational Site

    Shimane, 690-8556

  • GSK Investigational Site

    Tokyo, 103-0027

  • GSK Investigational Site

    Tokyo, 103-0028

  • GSK Investigational Site

    Tokyo, 158-0083

  • GSK Investigational Site

    Tokyo, 173-8610

Other trials in Japan

Spain15 sites

  • GSK Investigational Site

    Alicante, 03114

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Badalona / Barcelona

  • GSK Investigational Site

    Barakaldo (Vizcaya), 48903

  • GSK Investigational Site

    Cáceres, 10003

  • GSK Investigational Site

    Centelles

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Palma de Mallorca, 07010

  • GSK Investigational Site

    Pamplona, 31008

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

  • GSK Investigational Site

    Salt (gerona), 17190

  • GSK Investigational Site

    Sant Boi de Llobregat - Barcelona, 08830

  • GSK Investigational Site

    Santander, 38008

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Valencia, 46015

Other trials in Spain

Canada14 sites

  • GSK Investigational Site

    Burlington, Ontario, L7N 3V2

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6

  • GSK Investigational Site

    Grimsby, Ontario, L3M 1P3

  • GSK Investigational Site

    Montreal, Quebec, H2R 1V6

  • GSK Investigational Site

    Pointe-Claire, Quebec, H9R 3J1

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    Québec, Quebec, G3K 2P8

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • GSK Investigational Site

    Sarnia, Ontario, N7T 4X3

  • GSK Investigational Site

    Toronto, Ontario, M3H 5S4

  • GSK Investigational Site

    Toronto, Ontario, M5G 1N8

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

Czechia11 sites

  • GSK Investigational Site

    Český Krumlov, 381 01

  • GSK Investigational Site

    Kralupy nad Vltavou, 278 01

  • GSK Investigational Site

    Kyjov, 697 33

  • GSK Investigational Site

    Lovosice, 410 02

  • GSK Investigational Site

    Nový Jičín, 741 01

  • GSK Investigational Site

    Olomouc, 772 00

  • GSK Investigational Site

    Pilsen, 301 00

  • GSK Investigational Site

    Prague, 150 00

  • GSK Investigational Site

    Praha 5 - Radotin, 153 00

  • GSK Investigational Site

    Rokycany, 337 01

  • GSK Investigational Site

    Teplice, 415 10

Other trials in Czechia

Bulgaria10 sites

  • GSK Investigational Site

    Dimitrovgrad, 6400

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Plovdiv, 4000

  • GSK Investigational Site

    Rousse, 7000

  • GSK Investigational Site

    Sofia, 1000

  • GSK Investigational Site

    Sofia, 1202

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Sofia

  • GSK Investigational Site

    Troyan Municipality, 5600

  • GSK Investigational Site

    Varna, 9010

Other trials in Bulgaria

Poland10 sites

  • GSK Investigational Site

    Bydgoszcz, 85-681

  • GSK Investigational Site

    Gidle, 97-540

  • GSK Investigational Site

    Grudziądz, 86-300

  • GSK Investigational Site

    Iława, 14-200

  • GSK Investigational Site

    Krakow, 31-023

  • GSK Investigational Site

    Łomża, 18-400

  • GSK Investigational Site

    Olsztyn, 10-357

  • GSK Investigational Site

    Poznan, 60-569

  • GSK Investigational Site

    Szczecin, 71-124

  • GSK Investigational Site

    Warsaw, 01-456

Other trials in Poland

Greece9 sites

  • GSK Investigational Site

    Athens, 106 76

  • GSK Investigational Site

    Athens, 115 27

  • GSK Investigational Site

    Athens, 151 26

  • GSK Investigational Site

    Haidari / Athens, 124 62

  • GSK Investigational Site

    Heraklion, Crete, 71110

  • GSK Investigational Site

    Larissa, 41110

  • GSK Investigational Site

    Serres, 62100

  • GSK Investigational Site

    Thessaloniki, 546 42

  • GSK Investigational Site

    Thessaloniki, 56429

Other trials in Greece

South Africa9 sites

  • GSK Investigational Site

    Benoni, Gauteng, 1501

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    Gatesville, 7764

  • GSK Investigational Site

    Meyerspark, Gauteng, 0184

  • GSK Investigational Site

    Mowbray, 7700

  • GSK Investigational Site

    Newtown, 2113

  • GSK Investigational Site

    Somerset West, 7130

  • GSK Investigational Site

    Tygerberg, 7505

Other trials in South Africa

Chile7 sites

  • GSK Investigational Site

    Puente Alto - Santiago, Región Metro de Santiago, 8207257

  • GSK Investigational Site

    Rancagua, Reg Del Libert Bern Ohiggins, 2841959

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8880465

  • GSK Investigational Site

    Santiago, Región Metro de Santiago

  • GSK Investigational Site

    Talcahuano, 4270918

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

  • GSK Investigational Site

    Viña del Mar, 2570017

Other trials in Chile

Thailand6 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Chiang Mai, 50200

  • GSK Investigational Site

    Khon Kaen, 40002

  • GSK Investigational Site

    Nonthaburi, 11000

  • GSK Investigational Site

    Songkhla, 90110

Other trials in Thailand

Mexico4 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44100

  • GSK Investigational Site

    Monterrey, Nuevo León, 64020

  • GSK Investigational Site

    Puebla, Pue, Puebla, 72000

  • GSK Investigational Site

    Zapopan, Jalisco, 45040

Other trials in Mexico

About this study

Official title: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).

Read the detailed description

This is a 24-week, phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

Eligible subjects will be randomized to GSK573719/GW642444 125/25mcg, GSK573719 125mcg, GW642444 25mcg, and placebo treatment groups in a 3:3:3:2 ratio such that of the planned 1463 total number of randomized subjects approximately 399 subjects will be randomized to each active treatment group and 266 subjects will be randomized to placebo. All treatments will be administered once-daily in the morning by inhalation using a Novel Dry Powder Inhaler (Novel DPI).

There will be a total of 9 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 7 to 14 day run-in period followed by a 24-week treatment period. Clinic visits will be at Screening, Randomization (Day 1), Day 2, after 4, 8, 12, 16, and 24-weeks of treatment, and 1 day after the Week 24 Visit (also referred as Treatment Day 169). A follow-up contact for adverse assessment will be conducted by telephone approximately 7 days after Visit 9 or the Early Withdrawal Visit. The total duration of subject participation, including follow-up will be approximately 27 weeks. All subjects will be provided with albuterol/salbutamol for use on an "as-needed" basis throughout the run-in and study treatment periods.

At screening, pre-bronchodilator spirometry testing will be followed by post-albuterol/salbutamol spirometry testing. Post-albuterol/salbutamol FEV1 and FEV1/FVC values will be used to determine subject eligibility. To further characterize bronchodilator responsiveness, post-ipratropium testing will be conducted following completion of post-albuterol/salbutamol spirometry.

Spirometry will be conducted at each post-randomization clinic visit. Six hour post-dose serial spirometry will be conducted at Visits 2, 4, 6, and 8. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 9. All subjects will be provided with an electronic diary (eDiary) for completion daily in the evening throughout the run-in and treatment periods. Subjects will use the eDiary to record dyspnea scores using the Shortness of Breath with Daily Activities instrument (SOBDA), daily use of supplemental albuterol/salbutamol as either puffs/day from a metered-dose inhaler (MDI) and/or nebules used per day, and any healthcare contacts related to COPD.

Additional assessments of dyspnea will be obtained using the Baseline and Transition Dyspnea Index (BDI/TDI) which is an interviewer based instrument. At Visit 2, the severity of dyspnea at baseline will be assessed using the BDI. At subsequent visits (Visits 4, 6, and 8) change from baseline will be assessed using the TDI. Disease specific health status will be evaluated using the subject-completed St. George's Respiratory Questionnaire (SGRQ). The SGRQ will be completed at Visits 2, 4, 6, and 8. Administration of the SGRQ and BDI/TDI should be done prior to spirometry testing.

The occurrence of adverse events will be evaluated throughout the study beginning at Visit 2. SAEs will be collected over the same time period as for AEs. However, any SAEs assessed as related to study participation (e.g., study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK concomitant medication, will be recorded from the time a subject consents to participate in the study up to and including any follow up contact.

Additional safety assessments of vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory tests (hematology and chemistry) will be obtained at selected clinic visits. Blood samples for population pharmacokinetic analyses will be obtained.

At selected study sites, a subset of approximately 198 subjects will perform 24-hour serial spirometry during the study for evaluation of lung function over the dosing period. In conjunction with the serial spirometry, this subset of subjects will also perform 24 hour Holter monitoring and provide blood samples for PK analysis.

Being tested
62.5/25mcg, 62.5mcg, 25mcg, Placebo
Keywords
long-acting beta agonist, anticholinergic
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.

  • 62.5/25mcgDrug

    GSK573719/GW64244

  • 62.5mcgDrug

    GSK573719

  • 25mcgDrug

    GW642444

  • PlaceboDrug

    Placebo

Study groups in NCT01313650
Study groupRoleWhat they receive
GSK573719/GW642444Experimental62.5/25mcg
Receives: Drug: 62.5/25mcg
GSK573719Experimental62.5mcg
Receives: Drug: 62.5mcg
GW642444Experimental25mcg
Receives: Drug: 25mcg
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants.

    Measured: Baseline and Day 169

Secondary outcomes (2)

  1. Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)

    Considered an 'other' endpoint by the FDA. The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score,smoking status, center group, day, day by BDI focal score and day by treatment interactions.

    Measured: Day 168 (Week 24)

  2. Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at a particular visit was calculated as the WM at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.

    Measured: Baseline and Day 168

Timeline

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

  1. First posted14 Mar 2011 (estimated)
  2. Study start1 Mar 2011
  3. Primary completion1 Apr 2012
  4. Study completion5 Apr 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,538 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01313650
Sponsor's protocol ID
113373
Other IDs
2010-023349-32
Acronym
DB2113373
Status last verified
Aug 2018
First submitted
10 Mar 2011
Last updated
6 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

  • Donohue JF, Maleki-Yazdi MR, Kilbride S, Mehta R, Kalberg C, Church A. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med. 2013 Oct;107(10):1538-46. doi: 10.1016/j.rmed.2013.06.001. Epub 2013 Jul 2.

    PubMed 23830094

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 62.5/25mcg, 62.5mcg and 25mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 165 sites in 13 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 5 inclusion and 15 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 6 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 165 sites in United States, Russia, Japan, Spain, Canada and 8 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 4 Mar 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 (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (time frame: Baseline and Day 169). 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 NCT01313650, 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 6 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in