Pulmonary Disease, Chronic ObstructivePhase 2NCT00950807

GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

A Phase 2 study testing Tiotropium and GSK573179 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 19 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

The study will evaluate the dose response, 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?: Tiotropium and GSK573179
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 176 participants
Where: 19 sitesin 2 countries
Study dates: 1 Sep 2009to 15 Mar 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 35 to 70% of predicted normal

Who cannot join

Asthma
Other significant respiratory disorders besides COPD, including alpha-1 deficiency
Previous lung resection surgery
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
Any significant disease that would put subject at risk through study participation

Show all 21Show fewer

BMI greater than 35
Pacemaker
Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or C)
Cancer
Allergy or hypersensitivity to anticholinergics or inhaler excipients
Diseases that would contra-indicate 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
Previous use of GSK573719

Trial locations and contacts

19 sites in 2 countries.

Country

City, postcode or hospital

19 sites in 2 countries

United States10 sites

GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Easley, South Carolina, 29640
GSK Investigational Site
Gaffney, South Carolina, 29340
GSK Investigational Site
Greenville, South Carolina, 29615
GSK Investigational Site
Phoenix, Arizona, 85013
GSK Investigational Site
San Diego, California, 92117
GSK Investigational Site
Seneca, South Carolina, 29678
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Union, South Carolina, 29379
GSK Investigational Site
Upland, California, 91786

Other trials in United States

Germany9 sites

GSK Investigational Site
Berlin, 10787
GSK Investigational Site
Berlin, 13125
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Hamburg, 20253
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Wiesbaden, Hesse, 65187

Other trials in Germany

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of GSK573719 Administered Once- and Twice-Daily in Subjects With COPD

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

Read the detailed description

This is multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over, incomplete block design study to evaluation of 5 doses of GSK573719 administered once-daily and 3 doses of GSK573719 administered twice-daily over 14 days in subjects with COPD and will include tiotropium as an open-label active control. The pharmacokinetic profile of GSK573719 will also be evaluated.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium, Placebo, GSK573179
Keywords: Dose ranging, Chronic Bronchitis, Long-acting muscarinic antagonist, cross-over, COPD, Emphysema, Chronic Obstructive Pulmonary Disease (COPD), anticholinergic
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.

TiotropiumDrug
long-acting muscarinic receptor antagonist; 18mcg once-daily
PlaceboDrug
Inactive/ excipients only
GSK573179Drug
GSK573179 investigational drug

Study groups in NCT00950807
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo
Tiotropium	Active comparator	Tiotropium Receives: Drug: Tiotropium
Arm 1	Experimental	GSK573719 1000mcg once daily Receives: Drug: GSK573179
Arm 2	Experimental	GSK573719 500mcg once daily Receives: Drug: GSK573179
Arm 3	Experimental	GSK573719 250mcg once daily Receives: Drug: GSK573179
Arm 4	Experimental	GSK573719 125mcg once daily Receives: Drug: GSK573179
Arm 5	Experimental	GSK573719 62.5 mcg once daily Receives: Drug: GSK573179
Arm 6	Experimental	GSK573719 250mcg twice daily Receives: Drug: GSK573179
Arm 7	Experimental	GSK573719 125mcg twice daily Receives: Drug: GSK573179
Arm 8	Experimental	GSK573719 62.5mcg twice daily Receives: Drug: GSK573179

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 15 of Each Treatment Period
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 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis were performed using a mixed model with covariates of mean Baseline, period Baseline, treatment and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded 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 trough FEV1 at Day 15 minus the Baseline value for that treatment period.
Measured: Baseline and Day 15 of each treatment period (up to Study Day 71)

Secondary outcomes (2)

Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours Obtained Post-dose on Day 14 of Each Treatment Period
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) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean FEV1 was calculated using 0-24 hour (h) post-dose measurements at Day 14 of each treatment period, which included pre-dose and post-dose 1, 3, 6, 9, 12, 13, 15, 18, 21 and 24 hours. Analysis performed using a mixed model with covariates mean BL, period BL, treatment and period as fixed effects and participant as a random effect. BL is the FEV1 value recorded 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 trough FEV1 at Day 15 minus the BL value for that TP.
Measured: Baseline and Day 14 of each treatment period (TP; up to Study Day 70)
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
Serial FEV1 for OQ dosing is recorded at the pre-AM dose (time 0 h) and at 1, 3, 6, 9, 12,13, 15, 18, 21, 24 and 28 hs after the AM dose on D 14. For BID dosing, the 12 h AM dose corresponds to the pre-PM dose, 13 h AM dose corresponds to the 1 h PM dose, 15 h AM dose corresponds to the 3 h PM dose, 18 h AM corresponds to the 6 h PM dose, 21 h AM dose corresponds to 9 h PM dose, 24 h AM dose corresponds to the 12 h PM dose and 28 h AM dose corresponds to the 16 h PM dose in the table. Analysis performed using a mixed model with covariates of mean BL, period BL, trt, period, time, time by period BL interaction, time by mean BL interaction and time by trt interaction as fixed effects and par. as a random effect. BL is the FEV1 value recorded pre-dose on D 1 of each TP; mean BL is the mean of the BLs for each par. and period BL is the difference between the BL and the mean BL in each TP for each par. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.
Measured: Baseline and Day (D) 14 of each treatment period (TP; up to Study Day 70)

Timeline

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

1 Sep 200915 Mar 2010

First posted3 Aug 2009 (estimated)
Study start1 Sep 2009
Primary completion1 Mar 2010
Study completion15 Mar 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: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00950807
Sponsor's protocol ID: 113073
Status last verified: Oct 2017
First submitted: 30 Jul 2009
Last updated: 8 Nov 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.

Publications

Donohue JF, Anzueto A, Brooks J, Mehta R, Kalberg C, Crater G. A randomized, double-blind dose-ranging study of the novel LAMA GSK573719 in patients with COPD. Respir Med. 2012 Jul;106(7):970-9. doi: 10.1016/j.rmed.2012.03.012. Epub 2012 Apr 10.
PubMed 22498110

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of GSK573719 Administered Once- and Twice-Daily in Subjects With COPD
ClinicalTrials.gov ID: NCT00950807
Acronym / sponsor ID: 113073
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Dose ranging, Chronic Bronchitis, Long-acting muscarinic antagonist, cross-over, COPD, Emphysema, Chronic Obstructive Pulmonary Disease (COPD), anticholinergic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Sep 2009
Primary completion: 1 Mar 2010 (actual)
Study completion: 15 Mar 2010 (actual)
First posted: 3 Aug 2009 (estimated)
Results: Posted 4 Mar 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 dose response, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo
Tiotropium	Active comparator	Drug: TiotropiumTiotropium
Arm 1	Experimental	Drug: GSK573179GSK573719 1000mcg once daily
Arm 2	Experimental	Drug: GSK573179GSK573719 500mcg once daily
Arm 3	Experimental	Drug: GSK573179GSK573719 250mcg once daily
Arm 4	Experimental	Drug: GSK573179GSK573719 125mcg once daily
Arm 5	Experimental	Drug: GSK573179GSK573719 62.5 mcg once daily
Arm 6	Experimental	Drug: GSK573179GSK573719 250mcg twice daily
Arm 7	Experimental	Drug: GSK573179GSK573719 125mcg twice daily
Arm 8	Experimental	Drug: GSK573179GSK573719 62.5mcg twice daily

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 (21 listed)

Asthma
Other significant respiratory disorders besides COPD, including alpha-1 deficiency
Previous lung resection surgery
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

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
Tiotropiumlong-acting muscarinic receptor antagonist; 18mcg once-daily	Drug	Tiotropium
PlaceboInactive/ excipients only	Drug	Placebo
GSK573179GSK573179 investigational drug	Drug	Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6, Arm 7, Arm 8

Primary outcome

Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 15 of Each Treatment Period
Time frame: Baseline and Day 15 of each treatment period (up to Study Day 71)
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 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis were performed using a mixed model with covariates of mean Baseline, period Baseline, treatment and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded 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 trough FEV1 at Day 15 minus the Baseline value for that treatment period.

2 secondary outcomes

Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours Obtained Post-dose on Day 14 of Each Treatment Period
Time frame: Baseline and Day 14 of each treatment period (TP; up to Study Day 70)
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
Time frame: Baseline and Day (D) 14 of each treatment period (TP; up to Study Day 70)

Results and safety

Results posted to the registry on 4 Mar 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	59	56
UMEC 62.5 µg QD	13	13
UMEC 125 µg QD	14	13
UMEC 250 µg QD	12	12
UMEC 500 µg QD	13	12
UMEC 1000 µg QD	13	11
UMEC 62.5 µg BID	12	12
UMEC 125 µg BID	14	14
UMEC 250 µg BID	13	12
Tiotropium 18 µg QD	13	13

Primary outcome: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 15 of Each Treatment Period

Time frame: Baseline and Day 15 of each treatment period (up to Study Day 71). Least squares mean (Standard Error). Unit: Liters

Measure	Placebo n = 150	UMEC 62.5 µg QD n = 34	UMEC 125 µg QD n = 33	UMEC 250 µg QD n = 35	UMEC 500 µg QD n = 37	UMEC 1000 µg QD n = 29	UMEC 62.5 µg BID n = 31	UMEC 125 µg BID n = 33	UMEC 250 µg BID n = 32	Tio 18 µg QD n = 34
Value	-0.047 (0.017)	0.081 (0.033)	0.099 (0.034)	0.048 (0.033)	0.092 (0.032)	0.138 (0.036)	0.032 (0.035)	0.087 (0.034)	0.124 (0.034)	0.058 (0.033)

Placebo vs UMEC 62.5 µg QD: Mean Difference (Final Values): 0.128 (95% CI 0.060 to 0.196), p <0.001, Mixed Models Analysis
Placebo vs UMEC 125 µg QD: Mean Difference (Final Values): 0.147 (95% CI 0.077 to 0.216), p <0.001, Mixed Models Analysis
Placebo vs UMEC 250 µg QD: Mean Difference (Final Values): 0.095 (95% CI 0.027 to 0.162), p = 0.006, Mixed Models Analysis

Population analysed: Modified Intent-To-Treat (mITT) Population: all participants randomized to treatment who received at least one dose of study medication. All participants with \>=1 post-baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.

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 10 weeks.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 158 (0%)	11 of 158 (7%)	Not reported
UMEC 62.5 µg QD	0 of 35 (0%)	2 of 35 (5.7%)	Not reported
UMEC 125 µg QD	0 of 34 (0%)	3 of 34 (8.8%)	Not reported
UMEC 250 µg QD	2 of 36 (5.6%)	8 of 36 (22.2%)	Not reported
UMEC 500 µg QD	0 of 38 (0%)	9 of 38 (23.7%)	Not reported
UMEC 1000 µg QD	0 of 32 (0%)	13 of 32 (40.6%)	Not reported
UMEC 62.5 µg BID	0 of 34 (0%)	4 of 34 (11.8%)	Not reported
UMEC 125 µg BID	1 of 37 (2.7%)	4 of 37 (10.8%)	Not reported
UMEC 250 µg BID	0 of 33 (0%)	10 of 33 (30.3%)	Not reported
Tio 18 µg QD	0 of 35 (0%)	3 of 35 (8.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22498110Donohue JF, Anzueto A, Brooks J, Mehta R, Kalberg C, Crater G. A randomized, double-blind dose-ranging study of the novel LAMA GSK573719 in patients with COPD. Respir Med. 2012 Jul;106(7):970-9. doi: 10.1016/j.rmed.2012.03.012. Epub 2012 Apr 10.
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.

Related trials for Pulmonary Disease, Chronic Obstructive

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tiotropium and GSK573179 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 19 sites in 2 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 21 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Germany. 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 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 in Trough Forced Expiratory Volume in One Second (FEV1) at Day 15 of Each Treatment Period (time frame: Baseline and Day 15 of each treatment period (up to Study Day 71)). 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 NCT00950807, 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 8 Nov 2017.