Phase 2
Completed N=163
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)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01372410 ↗
Enrolled (actual)
163
Serious AEs
0.4%
Results posted
Feb 2014
Primary outcomePrimary: Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1) — 0.185; 0.156; 1.24; 1.24 Liters
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1) |
0.185; 0.156; 1.24; 1.24 | — |
| PRIMARY Final Dose-response Model for Trough FEV1 for ED50 (Potency) Parameter |
37.4; 38.2 | — |
| PRIMARY Final Dose-response Model Parameter β-FEV1MB-S0 for Trough FEV1 |
0.691; 0.686 | <0.0001 sig |
| PRIMARY Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 8 of Each Treatment Period |
-0.074; 0.038; 0.027; 0.049; 0.109; 0.051 | <0.001 sig |
| SECONDARY Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period |
-0.007; 0.068; 0.067; 0.065; 0.122; 0.069 | — |
| SECONDARY Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours After the Morning Dosing on Day 7 of Each Treatment Period |
-0.074; 0.043; 0.045; 0.059; 0.100; 0.062 | — |
Eligibility 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) 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
Data sourced from ClinicalTrials.gov (NCT01372410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.