Safety Study Using GSK233705 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease
NCT ID: NCT00279019
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2005-12-12
2006-06-13
Brief Summary
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GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK233705 when administered via inhalation in animal models supports the potential for use as a once-daily bronchodilator for chronic obstructive pulmonary disease.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Subjects receiving treatment sequence 1
Eligible subjects will receive treatment sequence 1; GSK233705 20 micrograms, GSK233705 100 micrograms, tiotropium and placebo.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 2
Eligible subjects will receive treatment sequence 2; GSK233705 20 micrograms, Placebo, GSK233705 50 micrograms and tiotropium.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 3
Eligible subjects will receive treatment sequence 3; GSK233705 20 micrograms, tiotropium, Placebo and GSK233705 50 micrograms.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 4
Eligible subjects will receive treatment sequence 4; GSK233705 20 micrograms, placebo, tiotropium and GSK233705 50 micrograms.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 5
Eligible subjects will receive treatment sequence 5; Placebo, tiotropium, GSK233705 20 micrograms and GSK233705 50 micrograms.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 6
Eligible subjects will receive treatment sequence 6; Placebo, GSK233705 20 micrograms, GSK233705 50 micrograms and tiotropium.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 7
Eligible subjects will receive treatment sequence 7; tiotropium, GSK233705 20 micrograms, GSK233705 50 micrograms and Placebo.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 8
Eligible subjects will receive treatment sequence 8; tiotropium, GSK233705 20 micrograms, Placebo and GSK233705 50 micrograms.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 9
Eligible subjects will receive treatment sequence 9; GSK233705 20 micrograms, tiotropium, GSK233705 50 micrograms and Placebo.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 10
Eligible subjects will receive treatment sequence 10; GSK233705 20 micrograms, GSK233705 100 micrograms, Placebo and tiotropium.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 11
Eligible subjects will receive treatment sequence 11; Placebo, GSK233705 20 micrograms, tiotropium, and GSK233705 50 micrograms.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 12
Eligible subjects will receive treatment sequence 12; Tiotropium, Placebo, GSK233705 20 micrograms and GSK233705 50 micrograms.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 13
Eligible subjects will receive treatment sequence 13; Placebo, GSK233705 20 micrograms, GSK233705 50 micrograms and GSK233705 100 micrograms.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 14
Eligible subjects will receive treatment sequence 14; GSK233705 20 micrograms, placebo, GSK233705 50 micrograms and GSK233705 100 micrograms.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 15
Eligible subjects will receive treatment sequence 15; GSK233705 20 micrograms, GSK233705 100 micrograms, Placebo and GSK233705 50 micrograms.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Subjects receiving treatment sequence 16
Eligible subjects will receive treatment sequence 16; GSK233705 20 micrograms, GSK233705 100 micrograms, GSK233705 50 micrograms and Placebo.
GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Interventions
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GSK233705
GSK233705 will be given orally with dosing strengths of 10, 50, 100 and 250 micrograms/blister via the DISKUS inhaler.
Tiotropium
Tiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
Placebo
Matching placebo will be given orally as overfoiled strips of 5 capsules, each containing lactose
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with COPD, as defined by the GOLD guidelines.
* Smoker or an ex-smoker with a smoking history of at least 10 pack years.
* FEV1/FVC \< 0.7 post-bronchodilator (salbutamol).
* FEV1 \<= 80% of predicted normal for height, age and gender after inhalation of salbutamol.
* Response to ipratropium bromide 9.
* Subject's weight is 60kg.
Exclusion Criteria
* FEV1 \<=50% of predicted after inhalation of salbutamol.
* Tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV.
* Has claustrophobia that may be aggravated by entering the plethysmography cabinet.
* Has prostate hypertrophy or narrow angle glaucoma.
* Diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, or asthma.
* Poorly controlled COPD.
* Participated in a Pulmonary Rehabilitation Program within 4 weeks prior to screening visit or will enter a program during the study.
* Had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.
* History of congestive heart failure, coronary insufficiency or cardiac arrhythmia.
* A mean QTc(B) value at screening \>440msec, the QTc(B) of all 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 120-210msec or an ECG that is not suitable for QT measurements.
* A history of elevated supine blood pressure or a mean blood pressure equal to or higher than 160/95 mmHg.
* A mean heart rate outside the range 40-90 bpm.
* QTc prolongation \>470msec or risk factors for torsades de pointes (heart failure NYHA II-IV, hypokalaemia, familial long QT syndrome).
* Receiving co-medication with drugs which prolong the QTc interval.
* Requires treatment with inhaled cromolyn sodium or nedocromil, oral beta-2-agonists, nebulised beta-2-agonists, nebulised anticholinergics or leukotriene modifiers.
* Unable to abstain from xanthines (other than caffeine.
* Unable to abstain from short-acting inhaled bronchodilators.
* Unable to abstain from long-acting inhaled bronchodilators.
* Changed dose of inhaled or oral corticosteroids within the last 6 weeks.
* Taking more than 10mg/day of prednisolone (or equivalent).
* Receiving treatment with long term or short-term oxygen therapy or requires nocturnal positive pressure for sleep apnea.
40 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, Germany
GSK Investigational Site
Berlin, , Germany
Countries
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Study Documents
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Document Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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AC2103473
Identifier Type: -
Identifier Source: org_study_id