Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD
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Purpose
The purpose of this study is to assess if 12 weeks' treatment with GSK573719 Inhalation Powder is safe and effective compared with placebo or no active drug intake, when administered once-daily in subjects with Chronic Obstructive Pulmonary Disease (COPD).
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: GSK573719 Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of GSK573719 Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease |
- Trough FEV1 [ Time Frame: Day 85 ] [ Designated as safety issue: No ]forced expired volume in one second (FEV1)
| Enrollment: | 206 |
| Study Start Date: | July 2011 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GSK573719
active drug
|
Drug: GSK573719
62.5 mcg
Other Name: GSK573719
Drug: GSK573719
125mcg
Other Name: GSK573719
|
|
Placebo Comparator: Placebo
no active drug
|
Other: Placebo
Placebo
Other Name: Placebo
|
Detailed Description:
Inhaled bronchodilators, such as beta 2 agonists and anticholinergics, and inhaled corticosteroids are the mainstays of therapy in patients diagnosed with COPD. Anticholinergic bronchodilators or long acting muscarinic receptor antagonists function by blocking endogenous airway smooth muscle cholinergic tone. Treatment with anticholinergics has been shown to significantly improve forced expiratory volume in 1 second (FEV1), resting and dynamic lung hyperinflation, symptoms, and exercise capacity in patients with COPD. Currently tiotropium is the only approved long acting muscarinic antagonist available for treatment of COPD.This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of GSK573719 Inhalation Powder of 2 doses when administered once-daily via Novel DPI compared with placebo over a treatment period of 12 weeks in subjects with COPD. There will be a total of 8 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 5 to 9 days run-in period followed by a 12-week treatment period. There will be 8 clinic visits during three of which serial spirometry will be performed . The total duration of subject participation in the study will be approximately 14 weeks.
This is a Phase III multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of GSK573719 Inhalation Powder 62.5 mcg and 125 mcg when administered once-daily via Novel DPI compared with placebo over a treatment period of 12 weeks in subjects with COPD.
Eligible subjects will be randomized 1:1:1 to receive either of the two doses of GSK573719 Inhalation Powder doses or placebo for 12 weeks.
There will be a total of 8 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 5 to 9 days run-in period followed by a 12-week treatment period. Clinic visits will be at Screening, Randomization (Visit 2), Day 3 and Weeks 2, 4, 8, and 12, and 1 day after the Week 12 visit (Visits 1 to 8, respectively). A safety follow-up assessment will be conducted by telephone approximately 7 days after the end of the study treatment (FU Phone Contact). The total duration of subject participation, including the follow-up period will be approximately 14 weeks. All subjects will be provided with albuterol/salbutamol for use on an "as-needed" basis throughout the run-in and treatment periods.
Pre-dose spirometry will be conducted at each clinic visit. Six hour post-dose serial spirometry will be conducted at Visit 2 and at Visits 5 and 7. All subjects will be provided with a paper diary for completion everyday throughout the run-in period and 12-week treatment period. Subjects will use the diary to record their daily use of supplemental albuterol/salbutamol and to record any medical problems experienced and any medications used.
At Visit 2 the Baseline Dyspnea Index (BDI) will be administered. The Transition Dyspnea Index (TDI) will be administered at Visits 5, 6, and 7.
Disease specific health status will be evaluated using the St. George's Respiratory Questionnaire (SGRQ) at Visit 2 and Visits 5, 6 and 7. Vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory tests (hematology and blood biochemistry) including pharmacokinetic samples will be obtained at selected clinic visits.
Approximately 198 subjects will be randomized to ensure at least 168 subjects complete the treatment period.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of COPD
- 10 pack-year or greater history of cigarette smoking
- Post-bronchodilator FEV1/FVC of <0.7
- Predicted FEV1 of 70% of normal or less
- Modified Medical Research Council (mMRC) dyspnea score of 2 or greater
Exclusion Criteria:
- Women who are pregnant, lactating, or planning to become pregnant
- Respiratory disorders other than COPD, including a current diagnosis of asthma
- Clinically significant non-respiratory diseases or abnormalities that are not adequately controlled
- Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the excipients of magnesium stereate or lactose used in the inhaler delivery device
- Hospitalization for COPD or pneumonia within 12 weeks prior to screening
- Lung volume reduction surgery within 12 weeks prior to screening
- Abnormal and clinically significant ECG findings at screening
- Clinically significant laboratory findings at screening
- Use of systemic corticosteroids, antibiotics for respiratory tract infections, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit
- Use of long-term oxygen therapy (12 hours or greater per day)
- Regular use of nebulized treatment with short-acting bronchodilators
- Participation in the acute phase of a pulmonary rehabilitation program
- A know or suspected history of alcohol or drug abuse
- Affiliation with the investigational site
- Previous use of GSK573719 or the combination of GSK573719/GW642444
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01387230 History of Changes |
| Other Study ID Numbers: | 115408 |
| Study First Received: | June 30, 2011 |
| Last Updated: | February 28, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Japan: Ministry of Health, Labor and Welfare |
Keywords provided by GlaxoSmithKline:
|
chronic obstructive pulmonary disease long acting muscarinic antagonist |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases |
Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013