N/A
N=31
Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT02141633 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Airway Blood Flow — 2.13; 13.05 ΔQaw (ul/min/ml)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- echocardiogram plus albuterol (Procedure); airway blood flow plus albuterol (Procedure); Fluticasone propionate (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Airway Blood Flow |
2.13; 13.05 | — |
| SECONDARY Echocardiogram |
-7.70; -9.04 | — |
Summary
The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2) compare the results between smokers and non-smokers, and 3) determine the effect of a 4-week treatment with an ICS on albuterol responsiveness of Qaw and the echocardiographic parameters. With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.
Eligibility Criteria
Inclusion Criteria
- Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited.
Exclusion Criteria
- Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women
- Cardiovascular disease and/or use of cardiovascular medications
- Subjects with known beta-adrenergic agonist intolerance
- A physician diagnosis of chronic airway disease (asthma, COPD, bronchiectasis, cystic fibrosis)
- Acute respiratory infection within four weeks prior to the study
- Use of any airway medication
- Abnormal pulmonary function
Data sourced from ClinicalTrials.gov (NCT02141633). 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.