Safety Study Using GSK233705 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00279019

Purpose

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.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: GSK233705	Phase I

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium Tiotropium bromide Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Safety Study
Official Title:	A Randomised, Double Blind, Placebo-Controlled, Double Dummy, 4-Way Cross-Over, Dose Ascending Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Inhaled Doses of GSK233705 and Tiotropium Bromide (18µg) Via DPI in COPD Patients

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Adverse events, blood pressure, heart rate, 12-lead electrocardiogram (ECG), Holter and Lead II ECG monitoring, ECG, lung function and clinical laboratory safety tests.

Secondary Outcome Measures:

Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters. Serial IOS and FEV1 measurements over 27 hours post-dose Serial sGaw, Raw measurements over 24 hours post-dose.

Estimated Enrollment:	32
Study Start Date:	December 2005

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279019

Locations

Germany
GSK Investigational Site
Berlin, Germany, 14050
Germany, Niedersachsen
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Germany, Schleswig-Holstein
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	AC2103473
Study First Received:	January 17, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00279019
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

COPD
GSK233705

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Guaifenesin

Phenylephrine
Lung Diseases
Respiration Disorders
Phenylpropanolamine
Tiotropium
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009