N/A
N=21
Positive Airway Pressure for the Treatment of Asthma
Asthma · Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01154699 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Asthma Control Test — 19.3; 19.8; 19.1; 19.6 units on a scale — p=0.8
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bilevel PAP (4 weeks) (Device); Usual Care (4 weeks) (Other); Washout Period (4 weeks) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asthma Control Test |
19.3; 19.8; 19.1; 19.6 | 0.8 |
| PRIMARY Airway Reactivity as Measured by Methacholine Challenge (PC20) |
1.3; 1.24; 0.88; 1.36 | 0.20 |
| SECONDARY Epworth Sleepiness Scale (ESS) |
9.1; 9.8; 9.7; 9.1 | 0.78 |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
6.8; 6.6; 6.1; 6.1 | 0.61 |
| SECONDARY Short Form (SF-36) Health Survey |
70.8; 74.0; 70.3; 73.5 | 0.94 |
| SECONDARY FEV1 %Predicted |
89.9; 87.1; 88.1; 89.7 | 0.76 |
Summary
Asthma is an extremely common disorder, which is becoming more prevalent. The purpose of this study is to examine how nocturnal lung volumes contribute to asthma severity, which may explain part of the link between asthma and obesity. The investigators seek to test the hypothesis that raising lung volumes during the night will improve asthma symptoms. The investigators work may lead to new targets for therapy.
Eligibility Criteria
Inclusion Criteria
- mild to moderate asthma, diagnosed by a physician, OR
- mild to moderate asthma and CPAP treated OSA. Must be compliant with CPAP therapy (greater than 4 hours per night, at least 4 nights/week)
Exclusion Criteria
- lung disease other than asthma or OSA
- medications known to affect respiratory function (apart from asthma and rhinitis therapy)
- abnormal nasal anatomy
- current smokers and ex-smokers (quit within the last 3 months, or >10 pack-years)
- pregnant women - women of child bearing age will undergo a urine pregnancy test before enrollment and during the course of the study, as some of the study procedures cannot be performed during pregnancy and because pregnancy often changes asthma symptoms and severity.
- severe asthma - defined as a recent exacerbation (doctor or ER visit for asthma, or oral steroid use, within the previous 4 weeks) or frequent exacerbations (>4 exacerbations in the last year.
- severe obstructive sleep apnea requiring supplemental oxygen in addition to CPAP therapy.
- the regular use of prescription (e.g. zolpidem) or over-the-counter sleep aids (e.g. Benadryl).
- Central sleep apnea
Data sourced from ClinicalTrials.gov (NCT01154699). 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.