Pulmonary Disease, Chronic ObstructivePhase 2NCT01030965

28-day Repeat Dose Study of GSK573719

A Phase 2 study testing GSK573719 125mcg, GSK573719 250mcg and GSK573719 500mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 20 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: GSK573719 125mcg, GSK573719 250mcg and GSK573719 500mcg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 285 participants
Where: 20 sitesin 4 countries
Study dates: 15 Dec 2009to 4 Jul 2010
Phase: Phase 2
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A signed and dated written informed consent prior to study participation
Males or females of non-childbearing potential
40 to 80 years of age
COPD diagnosis
10 pack-years history or greater of cigarette smoking
Post-bronchodilator FEV1/FVC ratio of 0.70 or less
Post-bronchodilator FEV1 of 25 to 70% of predicted normal

Who cannot join

Asthma
Other significant respiratory disorders besides COPD, including alpha-1 deficiency
Previous lung resection surgery
Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD
Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening
Hospitalization for COPD or pneumonia within 3 months of screening

Show all 26Show fewer

Any significant disease that would put subject at risk through study participation
BMI greater than 35
Pacemaker
Significantly abnormal ECG or clinical lab finding (including Hepatitis B or C)
Cancer
Allergy or hypersensitivity to anticholinergics or inhaler excipients
Diseases that would contraindicate the use of anticholinergics
Use of oral corticosteroids within 6 weeks of screening
Use of long-acting beta-agonists within 48 hours of screening
Use of tiotropium within 14 days of screening
Use of theophyllines or anti-leukotrienes within 48 hours of screening
Use of short-acting bronchodilators within 4 to 6 hours of screening
Use of investigational medicines within 30 days of screening
Use of high dose inhaled corticosteroids
Use of long-term oxygen therapy, CPAP or NIPPV
Participation in acute phase of pulmonary rehabilitation program
History of alcohol or drug abuse within 2 years prior to screening
History of psychiatric disease limiting validity of consent
Affiliation with the investigative site
Previous use of GSK573719

Trial locations and contacts

20 sites in 4 countries.

Country

City, postcode or hospital

20 sites in 4 countries

Germany7 sites

GSK Investigational Site
Berlin, 10787
GSK Investigational Site
Berlin, 13125
GSK Investigational Site
Berlin, 14057
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Hamburg, 20253
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055
GSK Investigational Site
Wiesbaden, Hesse, 65187

Other trials in Germany

Poland5 sites

GSK Investigational Site
Bialystok, 15-027
GSK Investigational Site
Bialystok
GSK Investigational Site
Gidle, 97-540
GSK Investigational Site
Krakow, 31-023
GSK Investigational Site
Lublin, 20-637

Other trials in Poland

United States4 sites

GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Madisonville, Kentucky, 42431
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Union, South Carolina, 29379

Other trials in United States

Estonia4 sites

GSK Investigational Site
Tallinn, 10138
GSK Investigational Site
Tallinn, 13419
GSK Investigational Site
Tallinn, 13619
GSK Investigational Site
Tartu, 51014

Other trials in Estonia

About this study

Official title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of GSK573719 Delivered Once-daily Over 28 Days in Subjects With COPD

The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: GSK573719 125mcg, GSK573719 250mcg, GSK573719 500mcg, Placebo
Keywords: Chronic Bronchitis, Anticholinergic, Emphysema, Long-acting muscarinic antagonist, COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema

What participants receive

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

GSK573719 125mcgDrug
125mcg once-daily
GSK573719 250mcgDrug
250mcg once-daily
GSK573719 500mcgDrug
500mcg once-daily
PlaceboDrug
once-daily

Study groups in NCT01030965
Study group	Role	What they receive
GSK573719 125mcg	Experimental	125mcg once-daily via novel dry powder inhaler Receives: Drug: GSK573719 125mcg
GSK573719 250mcg	Experimental	250mcg once-daily via novel dry powder inhaler Receives: Drug: GSK573719 250mcg
GSK573719 500mcg	Experimental	500mcg once-daily via novel dry powder inhaler Receives: Drug: GSK573719 500mcg
Placebo	Placebo comparator	once-daily via novel dry powder inhaler Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29
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 on Treatment Day 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.
Measured: Baseline and Day 29

Secondary outcomes (2)

Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28
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 weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean was calculated using the 0-6 hour post-dose measurements at Days 1 and 28, which included pre-dose (30 minutes prior to dosing on Day 1, or 24 hours after the previous day's dose on Day 28), and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between weighted mean at Days 1 and 28 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline, country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.
Measured: Baseline, Day 1, and Day 28
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Serial spirometry assessments were conducted on Day 1 and Day 28 over the course of 24 hours and were obtained 0 (Day 28 only), 1, 3, 6, 23, and 24 hours after dosing. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between FEV1 on Days 1 and 28 and Baseline.
Measured: Baseline, Day 1, and Day 28

Timeline

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

15 Dec 20094 Jul 2010

First posted14 Dec 2009 (estimated)
Study start15 Dec 2009
Primary completion4 Jul 2010
Study completion4 Jul 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 285 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01030965
Sponsor's protocol ID: 113589
Status last verified: Feb 2018
First submitted: 10 Dec 2009
Last updated: 9 Mar 2018
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.

Publications

Decramer M, Maltais F, Feldman G, Brooks J, Harris S, Mehta R, Crater G. Bronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patients. Respir Physiol Neurobiol. 2013 Jan 15;185(2):393-9. doi: 10.1016/j.resp.2012.08.022. Epub 2012 Sep 28.
PubMed 23026438

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 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of GSK573719 Delivered Once-daily Over 28 Days in Subjects With COPD
ClinicalTrials.gov ID: NCT01030965
Acronym / sponsor ID: 113589
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Bronchitis, Anticholinergic, Emphysema, Long-acting muscarinic antagonist, COPD
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 285 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 15 Dec 2009 (actual)
Primary completion: 4 Jul 2010 (actual)
Study completion: 4 Jul 2010 (actual)
First posted: 14 Dec 2009 (estimated)
Results: Posted 24 Feb 2014

Clinical summary

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

The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
GSK573719 125mcg	Experimental	Drug: GSK573719 125mcg125mcg once-daily via novel dry powder inhaler
GSK573719 250mcg	Experimental	Drug: GSK573719 250mcg250mcg once-daily via novel dry powder inhaler
GSK573719 500mcg	Experimental	Drug: GSK573719 500mcg500mcg once-daily via novel dry powder inhaler
Placebo	Placebo comparator	Drug: Placeboonce-daily via novel dry powder inhaler

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

A signed and dated written informed consent prior to study participation
Males or females of non-childbearing potential
40 to 80 years of age
COPD diagnosis
10 pack-years history or greater of cigarette smoking

Key exclusion criteria (26 listed)

Asthma
Other significant respiratory disorders besides COPD, including alpha-1 deficiency
Previous lung resection surgery
Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD
Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening

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
GSK573719 125mcg125mcg once-daily	Drug	GSK573719 125mcg
GSK573719 250mcg250mcg once-daily	Drug	GSK573719 250mcg
GSK573719 500mcg500mcg once-daily	Drug	GSK573719 500mcg
Placeboonce-daily	Drug	Placebo

Primary outcome

Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29
Time frame: Baseline and Day 29
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 on Treatment Day 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.

2 secondary outcomes

Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28
Time frame: Baseline, Day 1, and Day 28
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Time frame: Baseline, Day 1, and Day 28

Results and safety

Results posted to the registry on 24 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
Placebo	71	67
UMEC 125 µg	71	65
UMEC 250 µg	72	68
UMEC 500 µg	71	64

Primary outcome: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29

Time frame: Baseline and Day 29. Least squares mean (Standard Error). Unit: Liters

Measure	Placebo n = 67	UMEC 125 µg n = 64	UMEC 250 µg n = 68	UMEC 500 µg n = 64
Value	0.013 (0.025)	0.171 (0.025)	0.181 (0.025)	0.163 (0.025)

Placebo vs UMEC 125 µg: Mean Difference (Final Values): 0.159 (95% CI 0.088 to 0.229), p <0.001, Repeated Measures Analysis of Covariance
Placebo vs UMEC 250 µg: Median Difference (Final Values): 0.168 (95% CI 0.099 to 0.238), p <0.001, Repeated Measures Analysis of Covariance
Placebo vs UMEC 500 µg: Mean Difference (Final Values): 0.150 (95% CI 0.080 to 0.220), p <0.001, Repeated Measures Analysis of Covariance

Population analysed: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received \>=1 dose of randomized study medication in the treatment period. All participants with \>=1 post-BL assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 29.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 71 (0%)	6 of 71 (8.5%)	Not reported
UMEC 125 µg	1 of 71 (1.4%)	5 of 71 (7%)	Not reported
UMEC 250 µg	1 of 72 (1.4%)	9 of 72 (12.5%)	Not reported
UMEC 500 µg	1 of 71 (1.4%)	13 of 71 (18.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23026438Decramer M, Maltais F, Feldman G, Brooks J, Harris S, Mehta R, Crater G. Bronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patients. Respir Physiol Neurobiol. 2013 Jan 15;185(2):393-9. doi: 10.1016/j.resp.2012.08.022. Epub 2012 Sep 28.
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

20 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK573719 125mcg, GSK573719 250mcg and GSK573719 500mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 20 sites in 4 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 7 inclusion and 26 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany, Poland, United States, 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 24 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 in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29 (time frame: Baseline and Day 29). 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 NCT01030965, 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 9 Mar 2018.