Pulmonary Disease, Chronic ObstructivePhase 3NCT01716520

Cross-Over Study in Subjects With COPD, Evaluating Lung Function Response After Treatment With Once Daily Umeclidinium 62.5mcg, Vilanterol 25mcg, and Umeclidinium/Vilanterol 62.5/25mcg

A Phase 3 study testing Umeclidinium/Vilanterol 62.5/25 mcg, Umeclidinium 62.5 mcg and Vilanterol 25 mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 21 sites in 2 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

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Umeclidinium/Vilanterol 62.5/25 mcg, Umeclidinium 62.5 mcg and Vilanterol 25 mcg
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 182 participants
Where: 21 sitesin 2 countries
Study dates: Oct 2012to Mar 2013
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 Patient: Outpatient
Informed Consent: A signed and dated written informed consent prior to study participation
Age: Subjects 40 years of age or older at Visit 1
Gender: Male or female subjects.
COPD diagnosis: As defined by the American Thoracic Society/European Respiratory Society (ATS/ERS)
Severity of disease: A pre- and post-salbutamol FEV1/FVC ratio of <0.70 and a pre- and post-salbutamol FEV1 of ≤ 70% of predicted normal values at Visit 1
Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years at Visit 1
Female subject of non child-bearing potential OR a female subject of child bearing potential, with a negative pregnancy test at screening, and agreeing to consistently and correctly use one of the acceptable contraceptive methods

Who cannot join

Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
Asthma: A current diagnosis of asthma
Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions.
Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for < 5 years prior to Visit 1
Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as of 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.
Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.

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Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1.
12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1
Screening Labs: Significantly abnormal finding from clinical chemistry or hematology tests at Visit 1 as determined by the study investigator.
Medication Prior to Spirometry: Unable to withhold salbutamol for the 4 hour period required prior to spirometry testing at each study visit and at each spirometry test performed at home.
Medications Prior to Screening: Use of the prohibited medications according to defined time intervals prior to Visit 1
Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., ≤ 12 hours per day) is not exclusionary.
Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., salbutamol, ipratropium bromide) via nebulized therapy
Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
Affiliation with Investigator Site: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study.
Inability to read: In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete a questionnaire

Trial locations and contacts

21 sites in 2 countries.

Country

City, postcode or hospital

21 sites in 2 countries

Germany16 sites

GSK Investigational Site
Berlin, State of Berlin, 10367
GSK Investigational Site
Berlin, State of Berlin, 13086
GSK Investigational Site
Berlin, State of Berlin, 13581
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20253
GSK Investigational Site
Hanover, Lower Saxony, 30173
GSK Investigational Site
Leipzg, Saxony, 04109
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23552
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112
GSK Investigational Site
Munich, Bavaria, 80339
GSK Investigational Site
Nuremberg, Bavaria, 90402
GSK Investigational Site
Potsdam, Brandenburg, 14467
GSK Investigational Site
Potsdam, Brandenburg, 14469
GSK Investigational Site
Rodgau, Hesse, 63110

Other trials in Germany

Estonia5 sites

GSK Investigational Site
Haapsalu, 90502
GSK Investigational Site
Tallinn, 10117
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 Randomized, Double-Blind, 3-Way, Cross-Over Study to Evaluate Lung Function Response After Treatment With Umeclidinium 62.5mcg, Vilanterol 25mcg, and Umeclidinium/Vilanterol 62.5/25mcg Once-Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate the lung function response to UMEC/VI, UMEC, and VI in individual patients using a cross-over design. This is a multicenter, randomized, double-blind, 3-way crossover study. Eligible subjects will be randomized to a sequence of UMEC 62.5mcg, VI 25mcg, and UMEC/VI 62.5/25mcg. All subjects will receive each treatment once-daily for 14 days, and each treatment will be separated by a 10-14 day washout period. There will be a 5-7 day run-in period prior to randomization.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Umeclidinium/Vilanterol 62.5/25 mcg, Umeclidinium 62.5 mcg, Vilanterol 25 mcg
Keywords: long-acting muscarinic antagonist, long-acting beta-agonist, Chronic Obstructive Pulmonary Disease, vilanterol, umeclidinium
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.

Umeclidinium/Vilanterol 62.5/25 mcgDevice
Umeclidinium/Vilanterol 62.5/25 mcg once daily in the morning via novel dry powder inhaler (NDPI)
Umeclidinium 62.5 mcgDevice
Umeclidinium 62.5 mcg once daily in the morning via novel dry powder inhaler (NDPI)
Vilanterol 25 mcgDevice
Vilanterol 25 mcg once daily in the morning via novel dry powder inhaler (NDPI)

Study groups in NCT01716520
Study group	Role	What they receive
Umeclidinium/Vilanterol 62.5/25 mcg	Experimental	Umeclidinium/Vilanterol 62.5/25 mcg once daily in the morning via novel dry powder inhaler (NDPI) Receives: Device: Umeclidinium/Vilanterol 62.5/25 mcg
Umeclidinium 62.5 mcg	Experimental	Umeclidinium 62.5 mcg once daily in the morning via novel dry powder inhaler (NDPI) Receives: Device: Umeclidinium 62.5 mcg
Vilanterol 25 mcg	Experimental	Vilanterol 25 mcg once daily in the morning via novel dry powder inhaler (NDPI) Receives: Device: Vilanterol 25 mcg

What is being measured

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

Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type
FEV1 is a measure of lung function and 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 FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 [mean of the 23 and 24 hour assessments post Day 13 dosing]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP. Participants could have been classified as responders to both UMEC and VI.
Measured: Baseline and Day 14 of each treatment period (up to study day 83)

Secondary outcomes (3)

Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC, or VI According to FEV1 at Day 1 of Each Treatment Period (TP)
A responder is a par. with an increase from BL of >=12% and 200 milliliters (mL) at >=1 time point over 0-6 hours post-dose (PD) in FEV1 on Day 1. A non-responder (NR) is a par. with >=1 FEV1 assessment over 0-6 hours PD on Day 1 but no increase from BL of >=12% and 200 mL at any assessment(s). Missing: no FEV1 data recorded over 0-6 hours PD on Day 1. Response type is defined based on a par.'s response to each individual monotherapy treatment. A responder to UMEC is a par. who is a responder in the UMEC treatment period (TP) and either a NR or has missing data in the VI TP. A responder to VI is a par. who is a responder in the VI TP and either a NR or has missing data in the UMEC TP. A responder to UMEC and VI is a par. who is a responder in both the UMEC and VI TPs. A responder to neither is a par. who is a NR in both the UMEC and VI TPs. Missing: a par. who has missing data in both the UMEC and VI TPs, or who has missing data in one monotherapy period and is a NR in the other.
Measured: Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 71)
Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone
The number of participants with a larger change from Baseline in weighted mean FEV1 with UMEC/VI compared with UMEC and VI alone was recorded. Participants who improved on UMEC/VI had a larger change from Baseline difference in 0-6 hour weighted mean FEV1 on Day 14 on UMEC/VI compared to UMEC or VI alone. Baseline is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the Day 14 value minus the Baseline value for that treatment period.
Measured: Baseline and Day 14 of each treatment period (up to study day 83)
Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period
Trough FEV1 on Treatment Day 15 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 14. Analysis was performed using an ANCOVA model with covariates of treatment, period, mean Baseline (BL), period BL, response type, and treatment by response type interaction. A participant is a reponder to UMEC if they were a responder to UMEC monotherapy or a responder to both UMEC monotherapy and VI monotherapy. A participant is a responder to VI if they were a responder to VI monotherapy or a responder to both UMEC monotherapy or VI monotherapy. BL is the mean FEV1 recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean BL is the mean of the BLs for each participant, and period BL is the difference between BL and the mean BL in each treatment period for each participant. Change from BL for each treatment period is the Day 15 value minus the BL value for that treatment period.
Measured: Baseline and Day 15 of each treatment period (up to study day 84)

Timeline

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

Oct 2012Mar 2013

First posted30 Oct 2012 (estimated)
Study startOct 2012
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 182 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01716520
Sponsor's protocol ID: 116133
Status last verified: Nov 2016
First submitted: 11 Oct 2012
Last updated: 9 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, 3-Way, Cross-Over Study to Evaluate Lung Function Response After Treatment With Umeclidinium 62.5mcg, Vilanterol 25mcg, and Umeclidinium/Vilanterol 62.5/25mcg Once-Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01716520
Acronym / sponsor ID: 116133
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: long-acting muscarinic antagonist, long-acting beta-agonist, Chronic Obstructive Pulmonary Disease, vilanterol, umeclidinium
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 182 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 30 Oct 2012 (estimated)
Results: Posted 11 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Umeclidinium/Vilanterol 62.5/25 mcg	Experimental	Device: Umeclidinium/Vilanterol 62.5/25 mcgUmeclidinium/Vilanterol 62.5/25 mcg once daily in the morning via novel dry powder inhaler (NDPI)
Umeclidinium 62.5 mcg	Experimental	Device: Umeclidinium 62.5 mcgUmeclidinium 62.5 mcg once daily in the morning via novel dry powder inhaler (NDPI)
Vilanterol 25 mcg	Experimental	Device: Vilanterol 25 mcgVilanterol 25 mcg once daily in the morning via novel dry powder inhaler (NDPI)

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Type of Patient: Outpatient
Informed Consent: A signed and dated written informed consent prior to study participation
Age: Subjects 40 years of age or older at Visit 1
Gender: Male or female subjects.
COPD diagnosis: As defined by the American Thoracic Society/European Respiratory Society (ATS/ERS)

Key exclusion criteria (17 listed)

Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
Asthma: A current diagnosis of asthma
Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions.
Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for < 5 years prior to Visit 1
Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as of 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Umeclidinium/Vilanterol 62.5/25 mcgUmeclidinium/Vilanterol 62.5/25 mcg once daily in the morning via novel dry powder inhaler (NDPI)	Device	Umeclidinium/Vilanterol 62.5/25 mcg
Umeclidinium 62.5 mcgUmeclidinium 62.5 mcg once daily in the morning via novel dry powder inhaler (NDPI)	Device	Umeclidinium 62.5 mcg
Vilanterol 25 mcgVilanterol 25 mcg once daily in the morning via novel dry powder inhaler (NDPI)	Device	Vilanterol 25 mcg

Primary outcome

Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type
Time frame: Baseline and Day 14 of each treatment period (up to study day 83)
FEV1 is a measure of lung function and 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 FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 [mean of the 23 and 24 hour assessments post Day 13 dosing]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP. Participants could have been classified as responders to both UMEC and VI.

3 secondary outcomes

Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC, or VI According to FEV1 at Day 1 of Each Treatment Period (TP)
Time frame: Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 71)
Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone
Time frame: Baseline and Day 14 of each treatment period (up to study day 83)
Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period
Time frame: Baseline and Day 15 of each treatment period (up to study day 84)

Results and safety

Results posted to the registry on 11 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg	31	29
Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg	30	29
Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg	30	28
Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg	30	29
Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg	31	31
Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg	30	29

Primary outcome: Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type

Time frame: Baseline and Day 14 of each treatment period (up to study day 83). Least squares mean (Standard Error). Unit: Liters

Measure	UMEC 62.5 µg n = 171	VI 25 µg n = 171	UMEC/VI 62.5/25 µg n = 173
Responder to UMEC, n=90, 90, 88	0.216 (0.0166)	0.201 (0.0167)	0.337 (0.0166)
Responder to VI, n=99, 102, 100	0.189 (0.0150)	0.233 (0.0147)	0.331 (0.0148)
Responder to Neither, n=36, 37, 36	0.077 (0.0243)	0.057 (0.0240)	0.130 (0.0243)

UMEC 62.5 µg vs UMEC/VI 62.5/25 µg: Mean Difference (Final Values): 0.121 (95% CI 0.085 to 0.157), p <0.001, ANCOVA
VI 25 µg vs UMEC/VI 62.5/25 µg: Mean Difference (Final Values): 0.135 (95% CI 0.100 to 0.171), p <0.001, ANCOVA
UMEC 62.5 µg vs UMEC/VI 62.5/25 µg: Mean Difference (Final Values): 0.142 (95% CI 0.110 to 0.174), p <0.001, ANCOVA

Population analysed: Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received \>=1 dose of randomized study medication in a TP. Only par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number of par, analyzed reflects everyone in the ITT Population.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to Study Week 12).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
UMEC 62.5 µg	3 of 171 (1.8%)	8 of 171 (4.7%)	Not reported
VI 25 µg	1 of 171 (0.6%)	13 of 171 (7.6%)	Not reported
UMEC/VI 62.5/25 µg	3 of 173 (1.7%)	13 of 173 (7.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

21 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 17 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 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany, Estonia. 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 11 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 Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type (time frame: Baseline and Day 14 of each treatment period (up to study day 83)). 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 NCT01716520.

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 Jan 2017.