Phase 4
Completed N=342
A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT00784550 ↗
Enrolled (actual)
342
Serious AEs
5.9%
Results posted
Dec 2010
Primary outcomePrimary: Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint — 101; -16 milliliters (ml) — p=<0.001
Summary
The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD.
SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH & Co. KG.
ADVAIR DISKUS® are registered trademarks of the GSK group of companies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint |
101; -16 | <0.001 sig |
| SECONDARY Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint |
233; 77 | <0.001 sig |
| SECONDARY Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint |
95; -28 | 0.006 sig |
| SECONDARY Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint |
265; 87 | <0.001 sig |
| SECONDARY Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint |
107; -8 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint |
0.28; 0.04; 0.23; 0.17; 0.24; 0.16 | 0.069 |
Eligibility Criteria
Inclusion Criteria
- COPD diagnosis
- At least 10 pack year smoking history
- Post-albuterol FEV1 greater than or equal to 40% to less than or equal to 80% of predicted normal
- An FEV1/FVC ratio of less than or equal to 0.70
Exclusion Criteria
- Current diagnosis of asthma
- Other respiratory disorder other than COPD
- Abnormal and clinical significant ECG
- Chest x-ray clinically significant abnormality not believed to be due to COPD
- Body Mass Index of greater than or equal to 40/kg/m2
- Use of Long Term Oxygen Therapy
- Lung resection surgery
- Women pregnant or lactating at Visit 1
- Previously diagnosed cancer unless in complete remission for 2 years at Visit 1
Data sourced from ClinicalTrials.gov (NCT00784550). 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.