Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).
Interventions
DRUGFluticasone
fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment.
DRUGComparator: Placebo
Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 40 years and older * Clinical diagnosis of COPD for greater than one year * History of cigarette smoking
Exclusion criteria
* Other lung diseases (not including COPD), such as asthma * A condition that could interfere with your ability to perform exercise tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Dyspnea Score at Isotime During Exercise | 2 Weeks | Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period. Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 \[Best\] - 10 \[Worst\] ). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Endurance Time | 2 Weeks | Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period. |
Participant flow
Recruitment details
Patients were recruited from 1 center in Canada. Patient screening began 14-Dec-2006 and the first patient was randomized on 16-Feb-2007. Last patient last visit for the study was 31-Jul-2009.
Pre-assignment details
Patients must have met the following criteria: FEV1 (Forced expiratory volume in 1 second) less than or equal to (≤) 70% and FEV1/ FVC (forced vital capacity) ≤ to 0.7; FRC (functional residual capacity) greater than or equal to (≥)120% of the predicted value, and moderate to severe chronic activity-related dyspnea ≥ 120% of the predicted value.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 6.7 |
| Exercise endurance time at the beginning of Fluticasone Propionate | 9.67 Minutes STANDARD_DEVIATION 7.88 |
| Exercise endurance time at the beginning of placebo treatment | 9.42 Minutes STANDARD_DEVIATION 6.73 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
| Standardized Dyspnea Score at isotime at the beginning of Fluticasone | 4.50 Units on a Scale STANDARD_DEVIATION 1.87 |
| Standardized Dyspnea Score at isotime at the beginning of placebo | 4.75 Units on a Scale STANDARD_DEVIATION 2.13 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 12 | 2 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Standardized Dyspnea Score at Isotime During Exercise
Difference in standardized dyspnea rating at isotime during constant load exercise in patients with COPD between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period. Isotime is the duration of the shortest exercise test on all treatment days (or the longest exercise time point common to all constant-load exercise tests). The standardized dyspnea score will be measured with the modified 10-point Borg Scale (0 \[Best\] - 10 \[Worst\] ).
Time frame: 2 Weeks
Population: Intention to treat analysis. All patients were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate | Standardized Dyspnea Score at Isotime During Exercise | 3.58 Units on a Scale | Standard Deviation 2.14 |
| Placebo | Standardized Dyspnea Score at Isotime During Exercise | 4.50 Units on a Scale | Standard Deviation 2.18 |
90% CI: [-1.59, -0.25]
Secondary
Exercise Endurance Time
Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.
Time frame: 2 Weeks
Population: Intention to treat analysis. All patients were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate | Exercise Endurance Time | 12.92 Minutes | Standard Deviation 10.52 |
| Placebo | Exercise Endurance Time | 9.75 Minutes | Standard Deviation 6.93 |
90% CI: [-0.28, 6.61]