Safety And Tolerability Study In Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GSK233705
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring plethysmography, muscarinic receptor antagonist, COPD, repeat dosing
Eligibility 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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00376714
Brief Title
Safety And Tolerability Study In Patients With Chronic Obstructive Pulmonary Disease
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 16, 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 3, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
plethysmography, muscarinic receptor antagonist, COPD, repeat dosing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
45 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK233705
Primary Outcome Measure Information:
Title
Adverse events Blood pressure Heart rate 12-lead ECG Holter monitoring Lead II ECG monitoring Lung function Clinical laboratory safety tests.
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
GSK Investigational Site
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2105333
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2105333
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2105333
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2105333
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2105333
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2105333
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2105333
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Safety And Tolerability Study In Patients With Chronic Obstructive Pulmonary Disease
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