Safety Study Using GSK233705 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease
Status and phase
Completed
Phase 1
Conditions
Pulmonary Disease, Chronic Obstructive
Treatments
Drug: Placebo
Drug: Tiotropium
Drug: GSK233705
Details and patient eligibility
About
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.
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.
Enrollment
31 patients
Sex
All
Ages
40 to 75 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
31 participants in 16 patient groups
Subjects receiving treatment sequence 1
Experimental group
Description:
Eligible subjects will receive treatment sequence 1; GSK233705 20 micrograms, GSK233705 100 micrograms, tiotropium and placebo.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 2
Experimental group
Description:
Eligible subjects will receive treatment sequence 2; GSK233705 20 micrograms, Placebo, GSK233705 50 micrograms and tiotropium.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 3
Experimental group
Description:
Eligible subjects will receive treatment sequence 3; GSK233705 20 micrograms, tiotropium, Placebo and GSK233705 50 micrograms.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 4
Experimental group
Description:
Eligible subjects will receive treatment sequence 4; GSK233705 20 micrograms, placebo, tiotropium and GSK233705 50 micrograms.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 5
Experimental group
Description:
Eligible subjects will receive treatment sequence 5; Placebo, tiotropium, GSK233705 20 micrograms and GSK233705 50 micrograms.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 6
Experimental group
Description:
Eligible subjects will receive treatment sequence 6; Placebo, GSK233705 20 micrograms, GSK233705 50 micrograms and tiotropium.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 7
Experimental group
Description:
Eligible subjects will receive treatment sequence 7; tiotropium, GSK233705 20 micrograms, GSK233705 50 micrograms and Placebo.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 8
Experimental group
Description:
Eligible subjects will receive treatment sequence 8; tiotropium, GSK233705 20 micrograms, Placebo and GSK233705 50 micrograms.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 9
Experimental group
Description:
Eligible subjects will receive treatment sequence 9; GSK233705 20 micrograms, tiotropium, GSK233705 50 micrograms and Placebo.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 10
Experimental group
Description:
Eligible subjects will receive treatment sequence 10; GSK233705 20 micrograms, GSK233705 100 micrograms, Placebo and tiotropium.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 11
Experimental group
Description:
Eligible subjects will receive treatment sequence 11; Placebo, GSK233705 20 micrograms, tiotropium, and GSK233705 50 micrograms.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 12
Experimental group
Description:
Eligible subjects will receive treatment sequence 12; Tiotropium, Placebo, GSK233705 20 micrograms and GSK233705 50 micrograms.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 13
Experimental group
Description:
Eligible subjects will receive treatment sequence 13; Placebo, GSK233705 20 micrograms, GSK233705 50 micrograms and GSK233705 100 micrograms.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 14
Experimental group
Description:
Eligible subjects will receive treatment sequence 14; GSK233705 20 micrograms, placebo, GSK233705 50 micrograms and GSK233705 100 micrograms.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 15
Experimental group
Description:
Eligible subjects will receive treatment sequence 15; GSK233705 20 micrograms, GSK233705 100 micrograms, Placebo and GSK233705 50 micrograms.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Subjects receiving treatment sequence 16
Experimental group
Description:
Eligible subjects will receive treatment sequence 16; GSK233705 20 micrograms, GSK233705 100 micrograms, GSK233705 50 micrograms and Placebo.
Treatment:
Drug: GSK233705
Drug: Placebo
Drug: Tiotropium
Trial contacts and locations
3
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems