Status:
COMPLETED
Safety Study Using GSK233705 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
Brief Summary
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 act...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Of non-childbearing potential.
- 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:
- Past or present disease, which as judged by the Investigator and the Medical Monitor, may affect the outcome of this study.
- 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.
Exclusion
Key Trial Info
Start Date :
December 12 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2006
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00279019
Start Date
December 12 2005
End Date
June 13 2006
Last Update
September 25 2017
Active Locations (3)
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1
GSK Investigational Site
Hanover, Lower Saxony, Germany, 30625
2
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, Germany, 22927
3
GSK Investigational Site
Berlin, Germany, 14050