Last updated: 11/07/2018 09:10:46
A randomized, double blind, placebo controlled, incomplete block, crossover, dose ranging study to evaluate the dose response of GSK573719 administered once or twice daily over 7 days in patients with Chronic Obstructive Pulmonary Disease (COPD)AC4115321
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomized, double blind, placebo controlled, incomplete block, crossover, dose ranging study to evaluate the dose response of GSK573719 administered once or twice daily over 7 days in patients with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The purpose of this study is to further characterize the dose response of GSK573719 at doses of 15.6 micrograms (mcg) to 125 mcg once daily in patients with chronic obstructive pulmonary disease (COPD). Treatment with doses of GSK573719 dosed twice daily will also be included to further evaluate dosing frequency. Treatment with tiotropium (18 mcg) once daily via the Handihaler will be included as an active control. A placebo treatment will be included in order to evaluate absolute treatment effect of the different doses of GSK573719.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Final dose-response model for trough forced expiratory volume in one second (FEV1)
Timeframe: Day 7 and Day 8 of each treatment period (up to Study Day 50)
Final dose-response model for trough FEV1 for ED50 (potency) parameter
Timeframe: Day 7 and Day 8 of each treatment period (up to Study Day 50)
Final dose-response model parameter β-FEV1MB-S0 for trough FEV1
Timeframe: Day 7 and Day 8 of each treatment period (up to Study Day 50)
Change from Baseline in trough forced expiratory volume in one second (FEV1) on Day 8 of each treatment period
Timeframe: Baseline and Day 8 of each treatment period (up to Study Day 50)
Secondary outcomes:
Change from Baseline (BL) in serial FEV1 over time on Day 7 of each treatment period
Timeframe: Baseline and Day 7 of each treatment period (TP; up to Study Day 49)
Change from Baseline (BL) in weighted mean FEV1 over 0 to 24 hours after the morning dosing on Day 7 of each treatment period
Timeframe: Baseline and Day 7 of each treatment period (TP; up to Study Day 49)
Interventions:
Drug: GSK573719
Drug: Tiotropium
Drug: Placebo
Enrollment:
163
Observational study model:
Not applicable
Primary completion date:
2011-27-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide
Collaborators
Not applicable
Study date(s)
July 2011 to October 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- Outpatient
- A signed and dated written informed consent prior to study participation.
- Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- A current diagnosis of asthma
Inclusion and exclusion criteria
Inclusion criteria:
- Outpatient
- A signed and dated written informed consent prior to study participation.
- Male or female adults.
- 40 to 80 years of age at Visit 1
- Diagnosis of COPD
- Current or former cigarette smokers with a history of cigarette smoking of greater than or equal to 10 pack-years
- Post-albuterol forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC)<0.70 and post albuterol FEV1 of greater than or equal to 35% and less than or equal to 70% of predicted normal values
Exclusion criteria:
- Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- A current diagnosis of asthma
- Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer
- Other significant respiratory conditions in addition to COPD
- Other diseases that are uncontrolled including cancer in remission for less than 5 years
- Chest x-ray or CT scan with clinically significant abnormalities not believed to be due to the presence of COPD
- Hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate
- A medical condition that contraindicates study participation or use of an inhaled anticholinergic
- Hospitalization for COPD or pneumonia within 12 weeks of Visit 1
- Any previous lung resection surgery
- A body mass index (BMI) value of >35 kilogram (kg)/meter squared (m2)
- An abnormal and significant electrocardiogram finding at Visit 1
- Significantly abnormal finding from clinical chemistry or haematology tests at Visit 1.
- A positive Hepatitis B surface antigen or positive Hepatitis C antibody
- Medically unable to withhold albuterol (salbutamol) for the 6 hour period prior to study visits
- Use of depot corticosteroids within 12 weeks of Visit 1
- Use of oral or parenteral corticosteroids or antibiotics for lower respiratory tract infection within 6 weeks of Visit 1
- Use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if LABA/ICS therapy is discontinued within 30 days of Visit 1
- Use of ICS at a dose of >1000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1
- Initiation or discontinuation of ICS within 30 days of Visit 1
- Use of tiotropium or phosphodiesterase 4 inhibitors within 14 days of Visit 1
- Use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or inhaled long-acting beta-agonists within 48 hours of Visit 1
- Short-acting oral beta-agonists within 12 hours of Visit 1
- Use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component
- Use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1
- Use of inhaled short-acting beta-agonists, inhaled short-acting anticholinergics, or inhaled short-acting anticholinergic/short-acting beta-agonist combination products within 6 hours of Visit 1
- Use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer)
- Oxygen therapy prescribed for greater than 12 hours a day
- Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators
- Use of continuous positive airway pressure (CPAP), nocturnal positive pressure or non-invasive positive pressure ventilation (NIPPV), including use for sleep apnea.
- Acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1
- A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1
- Anyone affiliated with investigator site
- Previous use of GSK573719 or GSK53719/GW642444
Trial location(s)
Location
GSK Investigational Site
Edina, Minnesota, United States, 55438
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Easley, South Carolina, United States, 29640
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Costa Mesa, California, United States, 92626
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-27-10
Actual study completion date
2011-27-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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