Safety And Tolerability Study In Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00376714
First received: September 13, 2006
Last updated: May 15, 2009
Last verified: May 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 3 Period Crossover Study To Examine The Safety, Tolerability, Pharmacodynamics And Pharmacokinetics Of Repeat Inhaled Doses Of GSK233705B In COPD Subjects.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Adverse events Blood pressure Heart rate 12-lead ECG Holter monitoring Lead II ECG monitoring Lung function Clinical laboratory safety tests.

Secondary Outcome Measures:
  • Forced Expiratory Volume in 1 second (FEV1) Serial specific airways conductance (sGaw), airways resistance (Raw) Rescue medication usage Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters

Estimated Enrollment: 45
Study Start Date: August 2006
Intervention Details:
    Drug: GSK233705
    Other Name: GSK233705
  Eligibility

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

Inclusion Criteria:

  • Female subjects must be of non-childbearing potential including pre-menopausal females
  • Male subjects must agree to abstain from or use a condom during sexual intercourse with pregnant or lactating females
  • Subject diagnosed with COPD, as defined by the GOLD guidelines
  • Body weight greater than 50kg
  • Subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent).
  • Subject has FEV1/FVC < 0.7 post-bronchodilator (salbutamol).
  • Subject has FEV1 greater than or equal to 80% of predicted normal for height, age and gender after inhalation of 200 µg salbutamol.
  • Response to ipratropium bromide defined as:
  • Either: An increase in FEV1 of =12% and =150 mL at 2 h following inhalation of 80 ug of ipratropium bromide at the screening visit
  • or: a documented increase in FEV1 of =12% and =150 mL at 2 h following inhalation of 80 ug of ipratropium bromide within 6 months of screening and an increase in FEV1 of >6% and >100ml 2h following inhalation of 80 ug of ipratropium bromide at the screening visit (in order to allow for potential fluctuations in the response to ipratropium bromide in patients known to be responders to ipratropium bromide).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Subject is available to complete all study measurements and procedures.

Exclusion Criteria:

  • Subjects who have a past or present disease, judged by the Investigator and the Medical Monitor, to affect the outcome of this study.
  • The subject has a positive urine drug/ urine alcohol screen.
  • History of alcohol/drug abuse or dependence within 12 months of the study:
  • The subject has a positive pregnancy test.
  • Subject has FEV1 greater than or equal to 40% of predicted after inhalation of salbutamol.
  • A positive Hepatitis B or Hepatitis C result within 3 months of screening
  • The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period
  • The subject has donated a unit of blood within 30 days of screening, or, intends to donate during the study.
  • Subject has claustrophobia that may be aggravated by entering the plethysmography cabinet.
  • The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium bromide, atropine and any of its derivatives or milk protein/lactose.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
  • Subject is unable to use the DISKUS™ device correctly.
  • Subject has prostate hypertrophy or narrow angle glaucoma.
  • Use of prescription drugs (with the exception of those allowed in the protocol) and herbal remedies (e.g. St John's Wort) within 48 hours of each treatment period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376714

Locations
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2060
GSK Investigational Site
Liège, Belgium, 4000
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-413 45
GSK Investigational Site
Lund, Sweden, SE-221 85
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00376714     History of Changes
Other Study ID Numbers: AC2105333
Study First Received: September 13, 2006
Last Updated: May 15, 2009
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by GlaxoSmithKline:
COPD
muscarinic receptor antagonist
plethysmography
repeat dosing

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014