View Clinical Trial (Medical Research Study)
Positive Airway Pressure for the Treatment of Asthma
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02115 |
| Conditions: |
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Asthma - Sleep Apnea |
| Purpose: |
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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.
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| Study Summary: |
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Asthma is a chronic respiratory disease characterized by airway inflammation and airway
hyperresponsiveness, which causes airflow obstruction. It is extremely prevalent, affecting
an estimated 22 million Americans, and costly with loss of productivity and direct
healthcare costs in the billions of dollars. The incidence and prevalence of asthma are
increasing, both in the US and around the world. This increase comes despite greater
understanding of the inflammatory and allergic basis for asthma, and despite better
antiinflammatory medications. One explanation for the increasing prevalence of asthma is the
concomitant increase in obesity, with the majority of Americans now overweight or obese.
Numerous studies have convincingly linked asthma and obesity, and demonstrated increased
obstruction with weight gain and decreased obstruction with weight loss. However, the
mechanisms that underlie this linkage are not known.
We believe that low lung volumes contribute to the pathogenesis and severity of asthma.
End-expiratory lung volume is decreased in obesity, and likely falls further during sleep,
particularly in overweight and obese patients. Both upper and lower airway resistance
increase with decreasing lung volumes, as airways become smaller. However, prior work has
shown that lower airway resistance increases out of proportion to the decrease in lung
volume that occurs during sleep in asthma patients. This difference between controls and
people with asthma has not been further explored, yet may provide insight into asthma
pathogenesis and provide potential targets for therapy.
Therefore, we propose a series of experiments to define the impact of lung volumes during
sleep on airway resistance. One of these experiments will be to to test the hypothesis that
lung stretch can be used therapeutically by tonically and dynamically increasing lung
volumes during sleep using bi-level positive airway pressure. This research can help
delineate asthma pathogenesis and may help improve therapeutic options in this exceedingly
common disease.
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| Criteria: |
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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)
- BM > 25 kg/m2
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).
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| NCT ID: |
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NCT01154699 |
| Primary Contact: |
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Principal Investigator
Atul Malhotra, MD
Brigham and Women's Hospital
Alison M Foster
Phone: 617-732-8977
Email: afoster2@partners.org
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| Backup Contact: |
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Email: rowens@partners.org
Robert L Owens, MD
Phone: 617-525-8711
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| Location Contact: |
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Boston, Massachusetts 02115
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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