Phase 4
Completed N=442
Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®
Source: ClinicalTrials.gov NCT00542880 ↗Enrolled (actual)
442
Serious AEs
0.5%
Results posted
Aug 2012
Primary outcomePrimary: Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose — 15.1; 13.4 liters/minute
Summary
This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose |
15.1; 13.4 | — |
| SECONDARY PEF Before Morning Dose |
4.8; 7.9 | — |
| SECONDARY PEF 15 Minutes After Morning Dose |
19.9; 16.7 | — |
| SECONDARY PEF Before Evening Dose |
4; 1.8 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose |
0.0310; 0.0590 | — |
| SECONDARY FEV1 15 Minutes After Morning Dose |
0.1220; 0.1030 | — |
| SECONDARY FEV1 Before Evening Dose |
0.1470; 0.1060 | — |
| SECONDARY Change in PEF From Before Dose to 5 Minutes After Dose in the Morning |
0.0160; 0.0030 | — |
| SECONDARY Change in PEF From Before Dose to 15 Minutes After Dose in the Morning |
11.6; 6.1 | — |
| SECONDARY Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning |
15.8; 9.6 | — |
| SECONDARY Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning |
0.0930; 0.0280 | — |
| SECONDARY Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic |
0.1120; 0.0440 | — |
| SECONDARY Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic |
0.0950; 0.0490 | — |
| SECONDARY Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment) |
0.1920; 0.1240 | — |
| SECONDARY Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment) |
0.21; 0.14 | — |
| SECONDARY The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment) |
0.24; 0.19 | — |
Eligibility Criteria
Inclusion Criteria
- Outpatient, female or male aged ≥40 years, diagnosis of COPD with symptoms for at least 2 years
- FEV1 ≤50% of predicted normal value, pre-bronchodilator, FEV1/VC <70%
- Pre-bronchodilator
Exclusion Criteria
- Current respiratory tract disorder other than COPD
- History of asthma or rhinitis
- Significant or unstable cardiovascular disorder
Data sourced from ClinicalTrials.gov (NCT00542880). 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.