Phase 4
N=249
A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT00857766 ↗Enrolled (actual)
249
Serious AEs
6.4%
Results posted
Dec 2010
Primary outcome: Primary: Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint — 10.06; 9.87; 9.83; 9.95 meters per second (m/s) — p=0.065
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ADVAIR DISKUS™ 250/50mcg (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint |
10.06; 9.87; 9.83; 9.95; -0.24; 0.13 | 0.065 |
| SECONDARY Mean Change From Baseline in Augmentation Index (AIx) at the 12-Week Endpoint |
27.9; 27.8; 27.2; 27.6; -0.7; -0.4 | 0.469 |
| SECONDARY Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at the 12-Week Endpoint |
1444; 1480; 1588; 1500; 136; -3 | <0.001 sig |
Summary
The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure associated with risk of heart disease.
Eligibility Criteria
Inclusion Criteria
- Signed and dated written informed consent obtained from the subject and/or subject's legally acceptable representative prior to study participation.
- Males or females greater then or equal to 50 years of age.
- A post-albuterol FEV1/FVC ratio of greater then or equal to 10 pack-years .
Exclusion Criteria
- A current diagnosis of asthma
- A body mass index (BMI) of > or equal to 35kg/m2
- A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis).
Data sourced from ClinicalTrials.gov (NCT00857766). 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.