Trial Outcomes & Findings for Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036) (NCT NCT00387036)

Last Updated: 2016-01-21

Results Overview

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 \[Worst\] ).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

2 Weeks

Results posted on

2016-01-21

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Fluticasone Propionate Then Placebo Following 1 week Placebo run-in period (Period I), patients were randomized to receive fluticasone propionate 250 mcg Hydrofluoroalkane (HFA) 2 inhalations twice daily for a 2-week period (Period II) followed by 2-week washout period (Period III) and 2-week placebo 2 inhalations twice daily (Period IV).	Placebo Then Fluticasone Propionate Following 1 week Placebo run-in period (Period I), patients were randomized to receive placebo 2 inhalations twice daily for a 2-week period (Period II) followed by 2-week washout period (Period III) and 2-week fluticasone propionate 250 mcg HFA 2 inhalations twice daily (Period IV).
2-Week First Intervention STARTED	6	6
2-Week First Intervention COMPLETED	6	6
2-Week First Intervention NOT COMPLETED	0	0
2-Week Placebo Washout STARTED	6	6
2-Week Placebo Washout COMPLETED	6	6
2-Week Placebo Washout NOT COMPLETED	0	0
2-Week Crossover Second Intervention STARTED	6	6
2-Week Crossover Second Intervention COMPLETED	6	6
2-Week Crossover Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exercise Study in Patient With Chronic Obstructive Pulmonary Disease (0000-036)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=12 Participants
Age, Continuous	67.9 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Exercise endurance time at the beginning of Fluticasone Propionate	9.67 Minutes STANDARD_DEVIATION 7.88 • n=5 Participants
Exercise endurance time at the beginning of placebo treatment	9.42 Minutes STANDARD_DEVIATION 6.73 • n=5 Participants
Standardized Dyspnea Score at isotime at the beginning of Fluticasone	4.50 Units on a Scale STANDARD_DEVIATION 1.87 • n=5 Participants
Standardized Dyspnea Score at isotime at the beginning of placebo	4.75 Units on a Scale STANDARD_DEVIATION 2.13 • n=5 Participants

PRIMARY outcome

Timeframe: 2 Weeks

Population: Intention to treat analysis. All patients were included.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate n=12 Participants Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention	Placebo n=12 Participants Placebo administered 2 inhalations twice daily in first or second intervention
Standardized Dyspnea Score at Isotime During Exercise	3.58 Units on a Scale Standard Deviation 2.14	4.50 Units on a Scale Standard Deviation 2.18

SECONDARY outcome

Timeframe: 2 Weeks

Population: Intention to treat analysis. All patients were included.

Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period.

Outcome measures

Outcome measures
Measure	Fluticasone Propionate n=12 Participants Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention	Placebo n=12 Participants Placebo administered 2 inhalations twice daily in first or second intervention
Exercise Endurance Time	12.92 Minutes Standard Deviation 10.52	9.75 Minutes Standard Deviation 6.93

Adverse Events

Fluticasone Propionate

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fluticasone Propionate n=12 participants at risk Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention	Placebo n=12 participants at risk Placebo administered 2 inhalations twice daily in first or second intervention
Gastrointestinal disorders Gastrooesophageal Reflux Disease	8.3% 1/12 • Screening to 14 days after last dose of study medication.	0.00% 0/12 • Screening to 14 days after last dose of study medication.
Infections and infestations Gastrointestinal Infection	8.3% 1/12 • Screening to 14 days after last dose of study medication.	0.00% 0/12 • Screening to 14 days after last dose of study medication.
Infections and infestations Nasopharyngitis	8.3% 1/12 • Screening to 14 days after last dose of study medication.	0.00% 0/12 • Screening to 14 days after last dose of study medication.
Infections and infestations Pneumonia	8.3% 1/12 • Screening to 14 days after last dose of study medication.	0.00% 0/12 • Screening to 14 days after last dose of study medication.
Infections and infestations Viral Infection	8.3% 1/12 • Screening to 14 days after last dose of study medication.	0.00% 0/12 • Screening to 14 days after last dose of study medication.
Injury, poisoning and procedural complications Tooth Fracture	8.3% 1/12 • Screening to 14 days after last dose of study medication.	0.00% 0/12 • Screening to 14 days after last dose of study medication.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	8.3% 1/12 • Screening to 14 days after last dose of study medication.	16.7% 2/12 • Screening to 14 days after last dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/12 • Screening to 14 days after last dose of study medication.	8.3% 1/12 • Screening to 14 days after last dose of study medication.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Congestion	0.00% 0/12 • Screening to 14 days after last dose of study medication.	8.3% 1/12 • Screening to 14 days after last dose of study medication.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER