Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT00313209
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 933
- History of COPD for at least 12 months prior to baseline visit
- FEV1/FVC ratio (post-bronchodilator) ≤ 70%
- FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
Main
- COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo underlying medication: salmeterol 50 μg, twice daily, inhaled Roflumilast Roflumilast Roflumilast 500 µg underlying medication: salmeterol 50 μg, twice daily, inhaled
- Primary Outcome Measures
Name Time Method Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) Change from baseline over 24 weeks of treatment Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]
- Secondary Outcome Measures
Name Time Method Post-bronchodilator FEV1 Change from baseline over 24 weeks of treatment Mean change from baseline during the treatment period in post-bronchodilator FEV1 \[L\]
COPD Exacerbation Rate (Mild, Moderate or Severe) 24 weeks treatment period 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 \[ATS / ERS 2005\].
Transition Dyspnea Index (TDI) Focal Score Change from baseline over 24 weeks of treatment 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.
Shortness of Breath Questionnaire (SOBQ) Total Score Change from baseline over 24 weeks of treatment 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".
Trial Locations
- Locations (2)
Altana Pharma/Nycomed Investigational Sites
🇿🇦Kapstadt, South Africa
Altana Pharma/Nycomed Investigational Site
🇬🇧Watford, United Kingdom