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Pulmonary Disease, Chronic ObstructivePhase 3DB2113361NCT01313637

A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD

A Phase 3 study testing GSK573719/GW642444 125/25mcg, GSK573719 125mcg and GW642444 25mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 157 sites in 14 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?
GSK573719/GW642444 125/25mcg, GSK573719 125mcg and GW642444 25mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,493 participants
Where
157 sitesin 14 countries
Study dates
1 Mar 2011to 19 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 adequately controlled
  • Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, 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 GW642444

Trial locations and contacts

157 sites in 14 countries.

157 sites in 14 countries

United States24 sites

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Cherry Hill, New Jersey, 08003

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Jasper, Alabama, 35501

  • GSK Investigational Site

    Lincoln, Nebraska, 68506

  • GSK Investigational Site

    Livonia, Michigan, 48152

  • GSK Investigational Site

    Long Beach, California, 90822

  • GSK Investigational Site

    Los Angeles, California, 90095

  • GSK Investigational Site

    Orlando, Florida, 32822

  • GSK Investigational Site

    Palo Alto, California, 94304

  • GSK Investigational Site

    Panama City, Florida, 32405

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Plymouth, Minnesota, 55441

  • GSK Investigational Site

    Richmond, Virginia, 23225

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    San Diego, California, 92103-8415

  • GSK Investigational Site

    San Diego, California, 92117

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Topeka, Kansas, 66606

  • GSK Investigational Site

    Torrance, California, 90502

  • GSK Investigational Site

    Union, South Carolina, 29379

Other trials in United States

Germany24 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Berlin, 13581

  • GSK Investigational Site

    Berlin, 14059

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51069

  • GSK Investigational Site

    Dillingen an der Donau, Bavaria, 89407

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60596

  • GSK Investigational Site

    Geesthacht, Schleswig-Holstein, 21502

  • GSK Investigational Site

    Gelnhausen, Hesse, 63571

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    Hamburg, 20253

  • GSK Investigational Site

    Hamburg, 22143

  • GSK Investigational Site

    Künzing, Bavaria, 94550

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Munich, Bavaria, 80809

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

  • GSK Investigational Site

    Rodgau, Hesse, 63110

  • GSK Investigational Site

    Schmölln, Thuringia, 04626

  • GSK Investigational Site

    Schwabach, Bavaria, 91126

Other trials in Germany

Japan18 sites

  • GSK Investigational Site

    Aichi, 454-8502

  • GSK Investigational Site

    Aichi, 455-8530

  • GSK Investigational Site

    Aichi, 457-8510

  • GSK Investigational Site

    Chiba, 296-8602

  • GSK Investigational Site

    Fukuoka, 802-0052

  • GSK Investigational Site

    Fukuoka, 811-3195

  • GSK Investigational Site

    Fukuoka, 814-0180

  • GSK Investigational Site

    Fukuoka, 832-0059

  • GSK Investigational Site

    Hokkaido, 070-8644

  • GSK Investigational Site

    Ibaraki, 319-1113

  • GSK Investigational Site

    Kanagawa, 252-0001

  • GSK Investigational Site

    Miyagi, 989-1253

  • GSK Investigational Site

    Okayama, 714-0081

  • GSK Investigational Site

    Osaka, 596-8501

  • GSK Investigational Site

    Shizuoka, 434-8511

  • GSK Investigational Site

    Tokyo, 171-0014

  • GSK Investigational Site

    Tokyo, 194-0023

  • GSK Investigational Site

    Tokyo, 204-8585

Other trials in Japan

Netherlands13 sites

  • GSK Investigational Site

    Alkmaar, 1815 JD

  • GSK Investigational Site

    Almelo, 7609 PP

  • GSK Investigational Site

    Almere Stad, 1311 RL

  • GSK Investigational Site

    Beek, 6191 JW

  • GSK Investigational Site

    Ede, 6716 RP

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Enschede, 7513 ER

  • GSK Investigational Site

    Groningen, 9728 NP

  • GSK Investigational Site

    Helmond, 5707 HA

  • GSK Investigational Site

    Hoorn, 1624 NP

  • GSK Investigational Site

    Tubbergen, 7651 JH

  • GSK Investigational Site

    Veldhoven, 5504 DB

  • GSK Investigational Site

    Zutphen, 7207 AE

Other trials in Netherlands

Hungary12 sites

  • GSK Investigational Site

    Balassagyarmat, 2660

  • GSK Investigational Site

    Budapest, 1529

  • GSK Investigational Site

    Debrecen, 4032

  • GSK Investigational Site

    Deszk, 6772

  • GSK Investigational Site

    Farkasgyepű, 8582

  • GSK Investigational Site

    Gödöllő, 2100

  • GSK Investigational Site

    Gyöngyös, 3200

  • GSK Investigational Site

    Nyíregyháza, 4400

  • GSK Investigational Site

    Sátoraljaújhely, 3980

  • GSK Investigational Site

    Szikszó, 3800

  • GSK Investigational Site

    Szombathely, 9700

  • GSK Investigational Site

    Törökbálint, 2045

Other trials in Hungary

France10 sites

  • GSK Investigational Site

    Lyon, 69317

  • GSK Investigational Site

    Montauban, 82017

  • GSK Investigational Site

    Nice, 06000

  • GSK Investigational Site

    Perpignan, 66000

  • GSK Investigational Site

    Reims, 51092

  • GSK Investigational Site

    Tarbes, 65013

  • GSK Investigational Site

    Toulon, 83000

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Tours, 37044

  • GSK Investigational Site

    Vieux-Condé, 59690

Other trials in France

Sweden10 sites

  • GSK Investigational Site

    Gothenburg, SE-412 63

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Höllviken, SE-236 32

  • GSK Investigational Site

    Linköping, SE-582 16

  • GSK Investigational Site

    Luleå, SE-971 89

  • GSK Investigational Site

    Lund, SE-221 85

  • GSK Investigational Site

    Malmö, SE-211 52

  • GSK Investigational Site

    Stockholm, SE-111 57

  • GSK Investigational Site

    Stockholm, SE-113 61

  • GSK Investigational Site

    Vällingby, SE-162 68

Other trials in Sweden

Norway9 sites

  • GSK Investigational Site

    Bekkestua, 1319

  • GSK Investigational Site

    Bergen, 5017

  • GSK Investigational Site

    Bodø, 8005

  • GSK Investigational Site

    Elverum, 2408

  • GSK Investigational Site

    Kløfta, 2040

  • GSK Investigational Site

    Skedsmokorset, N-2020

  • GSK Investigational Site

    Stavanger, 4005

  • GSK Investigational Site

    Trondheim, 7011

  • GSK Investigational Site

    Trondheim, 7027

Other trials in Norway

Ukraine8 sites

  • GSK Investigational Site

    Donetsk, 83099

  • GSK Investigational Site

    Ivano-Frankivsk, 76018

  • GSK Investigational Site

    Kharkiv, 61037

  • GSK Investigational Site

    Kharkiv, 61124

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kyiv, 03680

  • GSK Investigational Site

    Simferopol, 95043

  • GSK Investigational Site

    Zaporizhia, 69035

Other trials in Ukraine

Denmark7 sites

  • GSK Investigational Site

    Aalborg, 9100

  • GSK Investigational Site

    Copenhagen, 2400

  • GSK Investigational Site

    Hvidovre, 2650

  • GSK Investigational Site

    Næstved, 4700

  • GSK Investigational Site

    Odense C, 5000

  • GSK Investigational Site

    Roedovre, 2610

  • GSK Investigational Site

    Roskilde, 4000

Other trials in Denmark

Estonia6 sites

  • GSK Investigational Site

    Haapsalu, 90502

  • GSK Investigational Site

    Pärnu, 80010

  • GSK Investigational Site

    Rakvere, 44316

  • GSK Investigational Site

    Tallinn, 10117

  • GSK Investigational Site

    Tallinn, 10138

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Slovakia6 sites

  • GSK Investigational Site

    Bardejov, 085 01

  • GSK Investigational Site

    Humenné, 066 01

  • GSK Investigational Site

    Poprad, 058 01

  • GSK Investigational Site

    Revúca, 050 01

  • GSK Investigational Site

    Spišská Nová Ves, 052 01

  • GSK Investigational Site

    Vráble, 952 01

Other trials in Slovakia

Belgium5 sites

  • GSK Investigational Site

    Aalst, 9300

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Genk, 3600

  • GSK Investigational Site

    Kortrijk, 8500

  • GSK Investigational Site

    Liège, 4000

Other trials in Belgium

Philippines5 sites

  • GSK Investigational Site

    Cebu City, 6000

  • GSK Investigational Site

    Dasmariñas, Cavite, 4114

  • GSK Investigational Site

    Marikina City, 1800

  • GSK Investigational Site

    Marilao, Bulacan, 3019

  • GSK Investigational Site

    Quezon City, 1109

Other trials in Philippines

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
GSK573719/GW642444 125/25mcg, GSK573719 125mcg, GW642444 25mcg, Placebo only
Keywords
anticholinergic, long-acting beta agonist
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.

  • GSK573719/GW642444 125/25mcgDrug

    Also called umeclidinium bromide/vilanterol trifenatate

    125/25mcg

  • GSK573719 125mcgDrug

    Also called umeclidinium bromide

    125mcg

  • GW642444 25mcgDrug

    Also called vilanterol trifenatate

    25mcg

  • Placebo onlyDrug

    Also called placebo

    Placebo

Study groups in NCT01313637
Study groupRoleWhat they receive
GSK573719/GW642444Experimental125/25mcg
Receives: Drug: GSK573719/GW642444 125/25mcg
GSK573719Experimental125mcg
Receives: Drug: GSK573719 125mcg
GW642444Experimental25mcg
Receives: Drug: GW642444 25mcg
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo only

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 Mar 2012
  4. Study completion19 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
1,493 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01313637
Sponsor's protocol ID
113361
Other IDs
2010-023348-33
Acronym
DB2113361
Status last verified
Jan 2018
First submitted
10 Mar 2011
Last updated
29 Jan 2018
Data monitoring committee
No

Publications

  • Celli B, Crater G, Kilbride S, Mehta R, Tabberer M, Kalberg CJ, Church A. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest. 2014 May;145(5):981-991. doi: 10.1378/chest.13-1579.

    PubMed 24385182

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK573719/GW642444 125/25mcg, GSK573719 125mcg and GW642444 25mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 157 sites in 14 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in United States, Germany, Japan, Netherlands, Hungary and 9 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 10 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 (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 NCT01313637, 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 29 Jan 2018.

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