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| ID | Type | Description | Link |
|---|---|---|---|
| 036 | |||
| 2006_039 |
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Termininated for business reasons
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To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Arm 1: drug, crossing over to Pbo comparator |
|
| 2 | Other | Arm 2: Pbo comparator, crossing over to drug |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone | Drug | fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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] ). | 2 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Endurance Time | Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period. | 2 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21917440 | Result | Guenette JA, Raghavan N, Harris-McAllister V, Preston ME, Webb KA, O'Donnell DE. Effect of adjunct fluticasone propionate on airway physiology during rest and exercise in COPD. Respir Med. 2011 Dec;105(12):1836-45. doi: 10.1016/j.rmed.2011.08.021. Epub 2011 Sep 13. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2-Week First Intervention |
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| 2-Week Placebo Washout |
| |||||||||||||
| 2-Week Crossover Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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] ). | Intention to treat analysis. All patients were included. | Posted | Mean | Standard Deviation | Units on a Scale | 2 Weeks |
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Screening to 14 days after last dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluticasone Propionate | Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | clinicaltrialsdisclosure@merck.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Comparator: Placebo | Drug | Placebo /inhalation, 2 inhalations bid. 14 Days of treatment. |
|
| NOT COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Exercise endurance time at the beginning of Fluticasone Propionate | The duration of loaded pedaling at the beginning of Fluticasone Propionate treatment. | Mean | Standard Deviation | Minutes |
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| Exercise endurance time at the beginning of placebo treatment | The duration of loaded pedaling at the beginning of placebo treatment | Mean | Standard Deviation | Minutes |
|
| Standardized Dyspnea Score at isotime at the beginning of Fluticasone | Standardized Dyspnea Score (0 (no discomfort) to 10 (most severe)) at isotime at the beginning of Fluticasone Propionate treatment. 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). | Mean | Standard Deviation | Units on a Scale |
|
| Standardized Dyspnea Score at isotime at the beginning of placebo | Standardized Dyspnea Score (0 (no discomfort) to 10 (most severe)) at isotime at the beginning of placebo treatment. 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) | Mean | Standard Deviation | Units on a Scale |
|
| OG001 |
| Placebo |
Placebo administered 2 inhalations twice daily in first or second intervention |
|
|
|
| Secondary | Exercise Endurance Time | Difference in exercise endurance time between Fluticasone Propionate treatment and placebo treatment at the end of the treatment period. | Intention to treat analysis. All patients were included. | Posted | Mean | Standard Deviation | Minutes | 2 Weeks |
|
|
|
|
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Placebo | Placebo administered 2 inhalations twice daily in first or second intervention | 0 | 12 | 2 | 12 |
| Gastrointestinal Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Upper Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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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.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |