Phase 3
Completed N=626
A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:
Source: ClinicalTrials.gov NCT01313494 ↗Enrolled (actual)
626
Serious AEs
17.6%
Results posted
Aug 2013
Primary outcomePrimary: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) — 0.049; -0.022 liters — p=<0.0001
Summary
The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) |
0.049; -0.022 | <0.0001 sig |
| SECONDARY Change From Baseline in Post-bronchodilator FEV1 |
0.045; -0.023 | — |
| SECONDARY Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC) |
0.100; -0.009 | — |
| SECONDARY Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) |
0.094; -0.007 | — |
| SECONDARY Change From Baseline in Pre-bronchodilator Forced Expiratory Flow 25-75% |
0.023; -0.010 | — |
| SECONDARY Change From Baseline in Post-bronchodilator Forced Expiratory Flow 25-75% |
0.022; -0.008 | — |
| SECONDARY Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Three Seconds (FEV3) |
0.072; -0.030 | — |
| SECONDARY Change From Baseline in Post-bronchodilator Forced Expiratory Volume in First Three Seconds (FEV3) |
0.064; -0.030 | — |
| SECONDARY Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Six Seconds (FEV6) |
0.084; -0.031 | — |
| SECONDARY Change From Baseline in Post-bronchodilator Forced Expiratory Volume in First Six Seconds (FEV6) |
0.078; -0.032 | — |
| SECONDARY Change From Baseline in Pre-bronchodilator Peak Expiratory Flow Rate (PEF) |
0.096; -0.036 | — |
| SECONDARY Change From Baseline in Post-bronchodilator Peak Expiratory Flow Rate (PEF) |
0.099; -0.030 | — |
| SECONDARY Change From Baseline in Pre-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity |
-0.570; -1.370 | — |
| SECONDARY Change From Baseline in Post-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity |
-0.320; -0.940 | — |
| SECONDARY Change From Baseline in Pre-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Expiratory Volume After 6 Seconds |
-0.210; -0.950 | — |
| SECONDARY Change From Baseline in Post-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Expiratory Volume After 6 Seconds |
-0.340; -0.420 | — |
| SECONDARY Change From Baseline in COPD Symptom Scores |
0.013; 0.064; -0.019; 0.036; 0.035; 0.037 | — |
| SECONDARY Change From Baseline in Use of Rescue Medication |
-0.485; -0.518 | — |
| SECONDARY Transition Dyspnoea Index (TDI) Total Score at Week 24 |
1.335; 1.396 | — |
| SECONDARY Percentage of Participants With Moderate or Severe COPD Exacerbations |
81.8; 84.7; 15.0; 12.8; 2.6; 1.9 | — |
| SECONDARY Mean Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year |
0.55; 0.44 | — |
| SECONDARY Time to Onset of First Moderate or Severe COPD Exacerbation |
67.0; 86.0 | — |
| SECONDARY Time to Onset of Second Moderate or Severe COPD Exacerbation |
119.5; 117.0 | — |
| SECONDARY Number of Participants With Adverse Events |
213; 196; 189; 172; 62; 48 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Willingness to sign a written informed consent
- Chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2009
- Chinese or Malay or Indian ethnicity
- History of chronic obstructive pulmonary disease symptoms for at least 12 months prior to baseline visit V0
- Forced expiratory volume in the first second/ Forced vital capacity (FEV1/FVC) ratio (post-bronchodilator) < 70%
- Forced expiratory volume in the first second (FEV1) (post-bronchodilator) < 50 % of predicted
- Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years
Main Exclusion Criteria:
- Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics not stopped at V0
- Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0
- History of asthma diagnosis in patients < 40 years of age or relevant lung disease other than COPD
- Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
- Known alpha-1-antitrypsin deficiency
Data sourced from ClinicalTrials.gov (NCT01313494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.