A Phase 3 interventional study of Roflumilast and Placebo in Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca. Completed at 287 sites in 8 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-11-06.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.
For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 1,568 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
500 mcg, once daily, oral administration in the morning
Drug: Roflumilast
once daily
Drug: Placebo
500 mcg, once daily, oral administration in the morning
once daily
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]
Time frame: Change from baseline over 52 weeks of treatment
COPD Exacerbation Rate (Moderate or Severe)
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management \[American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005\].
Time frame: 52 weeks treatment period
Post-bronchodilator FEV1 [L]
Mean change from baseline during the treatment period in post-bronchodilator FEV1 \[L\]
Time frame: Change from baseline over 52 weeks of treatment
Time to Mortality Due to Any Reason
Time frame: 52 weeks treatment period
Natural Log-transformed C-reactive Protein (CRP)
Mean change from baseline to the last post randomization measurement in natural log-transformed CRP
Time frame: Change from baseline to last post randomization measurement (52 weeks)
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.
Time frame: Change from baseline over 52 weeks of treatment
| Milestone | Roflumilast | Placebo |
|---|---|---|
| Started | 772 | 796 |
| Completed | 527 | 550 |
| Not completed | 245 | 246 |
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]
| mL | Roflumilast | Placebo |
|---|---|---|
| Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) | 33 ± 7 | -25 ± 7 |
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management \[American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005\].
| exacerbations per patient per year | Roflumilast | Placebo |
|---|---|---|
| COPD Exacerbation Rate (Moderate or Severe) | 1.210 (1.074 to 1.364) | 1.485 (1.333 to 1.655) |
Mean change from baseline during the treatment period in post-bronchodilator FEV1 \[L\]
| mL | Roflumilast | Placebo |
|---|---|---|
| Post-bronchodilator FEV1 [L] | 44 ± 7 | -17 ± 7 |
| days | Roflumilast | Placebo |
|---|---|---|
| Time to Mortality Due to Any Reason | 201.0 ± 116.9 | 214.6 ± 137.3 |
Mean change from baseline to the last post randomization measurement in natural log-transformed CRP
| mg/L | Roflumilast | Placebo |
|---|---|---|
| Natural Log-transformed C-reactive Protein (CRP) | 1.0840 (0.9766 to 1.2033) | 1.0233 (0.9228 to 1.1348) |
The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.
| scores on a scale | Roflumilast | Placebo |
|---|---|---|
| Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period | 0.662 ± 0.087 | 0.376 ± 0.084 |
Collected over 52 weeks treatment period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Roflumilast | — | 157/778 (20.2%) | 145/778 (18.6%) |
| Placebo | — | 183/790 (23.2%) | 81/790 (10.3%) |
| Event | Roflumilast | Placebo |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 87/778 | 121/790 |
| PneumoniaInfections and infestations | 18/778 | 10/790 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 4/778 | 5/790 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/778 | 1/790 |
| DiarrhoeaGastrointestinal disorders | 4/778 | 0/790 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 2/778 | 4/790 |
| Myocardial infarctionCardiac disorders | 2/778 | 4/790 |
| Atrial fibrillationCardiac disorders | 3/778 | 2/790 |
| Cardiopulmonary failureCardiac disorders | 3/778 | 0/790 |
| HypokalaemiaMetabolism and nutrition disorders | 3/778 | 0/790 |
| Event | Roflumilast | Placebo |
|---|---|---|
| Weight decreasedInvestigations | 65/778 | 20/790 |
| DiarrhoeaGastrointestinal disorders | 64/778 | 23/790 |
| NasopharyngitisInfections and infestations | 35/778 | 47/790 |
| Age, Continuous(years) | Roflumilast | Placebo | Total |
|---|---|---|---|
| Mean | 63.92 ± 9.2 | 64.31 ± 9.0 | 64.12 ± 9.1 |
| Sex: Female, Male(Participants) | Roflumilast | Placebo | Total |
|---|---|---|---|
| Female | 162 | 148 | 310 |
| Male | 610 | 648 | 1258 |
Showing the first 100 of 287 sites across 8 countries.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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