Phase 4
N=20
Effect of Brovana and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
COPD
Bottom Line
View on ClinicalTrials.gov: NCT00773786 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week — 0.069; 0.010; 0.121; 0.023 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Arformoterol (Brovana) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Trinity Health Of New England
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week |
0.069; 0.010; 0.121; 0.023 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) at 1 Week |
0120; 0.000; 0.080; -0.062 | — |
| SECONDARY Change From Baseline in Inspiratory Capacity at 1 Week |
0.001; -0.019; 0.113; -0.004 | — |
Summary
This will be a double-blind crossover trial in 20 patient with stable COPD. Data from this study will provide proof-of-concept information on whether the (anticipated) additional bronchodilator effect of Brovana added to tiotropium will lead to a meaningful improvement in the patient-centered outcome, exercise capacity. This study will only evaluate the effects of short-term (1-week) administration of Brovana. If results are positive, it would provide preliminary data for further, multicenter investigations.
Eligibility Criteria
Inclusion Criteria
- Informed consent (Approval by the St. Francis Hospital Institutional Review Board (IRB) will be required before study initiation)
- Adults, age > 40 years
- A clinical diagnosis of COPD, with spirometric confirmation: post-bronchodilator forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC) ( < 0.70
- Moderate, severe and very severe airflow limitation by GOLD criteria.
- Clinically stable respiratory disease
- The perceived ability to participate in pulmonary testing and exercise testing
- COPD, stable state
Exclusion criteria
- Women of childbearing potential
- Asthma
- Supplemental oxygen use or anticipated oxygen desaturation < 85% at peak exercise (patients who desaturate below 85% on the incremental study will be excluded)
- Co-morbidity that would interfere with the patient participating in the study, including the exercise testing. Examples include unstable cardiac disease, arthritis, psychological problems that would interfere with participation
- An exacerbation requiring therapy or any change in maintenance COPD therapy within six weeks of testing
- A history of a prolonged QT interval
- Recent exacerbation of COPD
Data sourced from ClinicalTrials.gov (NCT00773786). 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.