A Phase 3 interventional study of Roflumilast and Placebo in Chronic Obstructive Pulmonary Disease (COPD), sponsored by AstraZeneca. Completed at 134 sites in 10 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-12-14.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The aim of the study is to compare the efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 933 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:
Roflumilast 500 µg underlying medication: salmeterol 50 μg, twice daily, inhaled
Drug: Roflumilast
Placebo underlying medication: salmeterol 50 μg, twice daily, inhaled
Drug: Placebo
500 µg, 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 24 weeks of treatment
Post-bronchodilator FEV1
Mean change from baseline during the treatment period in post-bronchodilator FEV1 \[L\]
Time frame: Change from baseline over 24 weeks of treatment
COPD Exacerbation Rate (Mild, Moderate or Severe)
Mean rate of COPD exacerbations requiring rescue medication of 3 or more puffs/day on at least 2 consecutive days (=mild COPD exacerbations), or 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 \[ATS / ERS 2005\].
Time frame: 24 weeks treatment period
Transition Dyspnea Index (TDI) Focal Score
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 24 weeks of treatment
Shortness of Breath Questionnaire (SOBQ) Total Score
Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is "not at all breathless" and five is "maximally breathless or too breathless to do the activity".
Time frame: Change from baseline over 24 weeks of treatment
| Milestone | Roflumilast | Placebo |
|---|---|---|
| Started | 466 | 467 |
| Completed | 359 | 385 |
| Not completed | 107 | 82 |
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) | 39 ± 9 | -10 ± 9 |
Mean change from baseline during the treatment period in post-bronchodilator FEV1 \[L\]
| mL | Roflumilast | Placebo |
|---|---|---|
| Post-bronchodilator FEV1 | 68 ± 9 | 8 ± 9 |
Mean rate of COPD exacerbations requiring rescue medication of 3 or more puffs/day on at least 2 consecutive days (=mild COPD exacerbations), or 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 \[ATS / ERS 2005\].
| exacerbations per patient per year | Roflumilast | Placebo |
|---|---|---|
| COPD Exacerbation Rate (Mild, Moderate or Severe) | 1.9 (1.5 to 2.5) | 2.4 (1.9 to 3.1) |
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 |
|---|---|---|
| Transition Dyspnea Index (TDI) Focal Score | 1.2 ± 0.1 | 1.1 ± 0.1 |
Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is "not at all breathless" and five is "maximally breathless or too breathless to do the activity".
| scores on a scale | Roflumilast | Placebo |
|---|---|---|
| Shortness of Breath Questionnaire (SOBQ) Total Score | -0.6 ± 0.7 | -1.1 ± 0.7 |
Collected over 24 weeks treatment period. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Roflumilast | — | 36/466 (7.7%) | 165/466 (35.4%) |
| Placebo | — | 42/467 (9%) | 143/467 (30.6%) |
| Event | Roflumilast | Placebo |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 7/466 | 11/467 |
| Myocardial infarctionCardiac disorders | 2/466 | 1/467 |
| Atrial fibrillationCardiac disorders | 2/466 | 0/467 |
| Aortic aneurysmVascular disorders | 2/466 | 1/467 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/466 | 2/467 |
| Cardiac failureCardiac disorders | 0/466 | 2/467 |
| PneumoniaInfections and infestations | 1/466 | 2/467 |
| Renal failure acuteRenal and urinary disorders | 1/466 | 2/467 |
| Renal failureRenal and urinary disorders | 0/466 | 2/467 |
| BronchospasmRespiratory, thoracic and mediastinal disorders | 1/466 | 0/467 |
| Event | Roflumilast | Placebo |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 70/466 | 103/467 |
| Weight decreasedInvestigations | 39/466 | 5/467 |
| DiarrhoeaGastrointestinal disorders | 38/466 | 15/467 |
| NasopharyngitisInfections and infestations | 33/466 | 35/467 |
| NauseaGastrointestinal disorders | 25/466 | 1/467 |
| Age, Continuous(years) | Roflumilast | Placebo | Total |
|---|---|---|---|
| Mean | 64.9 ± 8.7 | 64.9 ± 9.3 | 64.9 ± 9.0 |
| Gender(Participants) | Roflumilast | Placebo | Total |
|---|---|---|---|
| Female | 147 | 168 | 315 |
| Male | 319 | 299 | 618 |
Showing the first 100 of 134 sites across 10 countries.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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