AsthmaNCT01026298
Asthma and Obstructive Sleep Apnea (OSA)
A study testing FDA-Approved Treatment in people with Asthma and Obstructive Sleep Apnea, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is a common but under-diagnosed form of sleep disordered breathing (SDB). Asthma is a common disease with rising prevalence, which continues to pose significant morbidity and costs. Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Asthma, Obstructive Sleep Apnea
- What is being tested?
- FDA-Approved Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 744 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to 25 Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of not well-controlled (NWC) asthma (National Asthma Education and Prevention Program Guidelines step 2, 3, 4), as diagnosed by an asthma physician
- stable doses of standard therapy for 2 months prior to enrollment. These regimens will include: inhaled corticosteroids (ICS) for mild-persistent step; ICS and inhaled long-acting β-adrenergics (LABA) or ICS and leukotriene modifier (LTMs) agents for moderate-persistent step; high doses of ICS, LABA or LTMs, with or without oral steroids at stable doses, for patients in severe step
- adherence to the current asthma medications regimen, demonstration of a proper inhaler technique; agreement for maintaining the same asthma regimen (except rescue bronchodilators) as clinical condition permits (if an exacerbation occurs during the first 4-week period, the subject will be excluded as discussed below), and willingness to complete diaries of asthma symptoms, rescue bronchodilator use, peak flow meter (PEF) recordings as well as asthma-related urgent doctor's and emergency room visits and hospitalizations for the 3 months duration of the study
- moderate to high probability for OSA (SA-SDQ scores ≥31 for males and ≥28 for females) or high clinical suspicion for OSA
- preliminary agreement to treatment with continuous positive airway pressure (CPAP) if OSA is identified and current CPAP treatment criteria are met [patients with moderate to severe OSA (AHI>15 events/hour), patients with mild OSA (AHI 5-15 events/hour) in association with EDS or co-morbid conditions (HTN, stable ischemic heart disease, prior stroke, impaired cognition, mood disorders, insomnia
- ability to read and write
- ability and willingness to return to the Medical Center as required by the study protocol.
Who cannot join
- asthma exacerbation in the prior 2 months
- acute sinusitis
- poorly controlled rhinitis or gastroesophageal reflux disease (GERD)
- any unstable medical or psychiatric illness likely to impede participation in the protocol during the next year
- evidence of co-existent lung disease, in particular allergic broncho-pulmonary aspergillosis or chronic obstructive pulmonary disease (COPD)
- treated OSA or another primary sleep disorder
Show all 13Show fewer
- evidence of medical instability due to OSA at first sleep study visit
- subjects with excessive daytime sleepiness to a degree that puts the subject or people around at risk of accidents (motor vehicle or work-related). In these cases we will facilitate expedited sleep evaluations through primary providers
- historical evidence of collagen vascular disease
- craniofacial abnormalities precluding the use of CPAP; 11) current cigarette smoking or within the prior 6 months (self-report and medical records
- pregnancy (documented via urine-human chorionic gonadotropin detection test) or desire to become pregnant during the following 3 months
- mental impairment limiting the ability to provide informed consent
- current alcohol (as per the NIH cutoffs56 presented below) or recreational drug use (for both, based on medical records review and self-report without any prospective recording); women drinking more than 3 drinks at one time or more than 7 standard drinks a week or men drinking more than 4 drinks at one time or more than 14 standard drinks a week will be excluded. A standard drink is defined as one can or bottle of beer (12 fl oz), one glass of wine (5 fl oz), or one mixed drink containing 1.5 fl oz of hard liquor.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: The Relationship Between Asthma and Obstructive Sleep Apnea (OSA) - A Pilot Study of the Effects of OSA and Its Treatment on Asthma
Obstructive sleep apnea (OSA) is a common but under-diagnosed form of sleep disordered breathing (SDB). Asthma is a common disease with rising prevalence, which continues to pose significant morbidity and costs. In spite of considerable progress in our understanding of asthma, a large number of individuals with asthma continue to have symptoms and subsequently, have a poor functional status, poor quality of life and increased health care costs. In many cases no apparent cause is found and optimal therapy does not achieve its goal. While recent data suggests that OSA is common in severe asthma, the prevalence of OSA and its predisposing factors have not been studied.
- Conditions
- Asthma, Obstructive Sleep Apnea
- Being tested
- FDA-Approved Treatment
- Keywords
- asthma, obstructive sleep apnea, severe asthma, OSA
- Medical subject headings
- Asthma, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDA-Approved TreatmentOther
8 weeks of treatment with Continuous Positive Airway Pressure (CPAP)
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 8 weeks, no intervention for OSA |
| CPAP group | Active comparator | 8-week randomized-controlled period of CPAP treatment Receives: Other: FDA-Approved Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence and risk factors for OSA symptoms in a specialty clinic-based sample of individuals with asthma.
Measured: 7 days
Secondary outcomes (2)
To assess changes in subjective and objective asthma measures in subjects with asthma and co-morbid OSA, after 8 weeks of treatment with continuous positive airway pressure (CPAP) versus no intervention (control).
Measured: 56 days
To examine whether 8 weeks of CPAP for OSA improves quality of life, insomnia, daytime sleepiness and fatigue, and health resource utilization in individuals with asthma.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startMar 2007
- Primary completion7 May 2012
- Study completion25 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihaela Teodorescu, MD, Principal investigator, UW Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026298
- Sponsor's protocol ID
- 2012-1038
- Other IDs
- H-2007-0034, A534285, SMPH/MEDICINE/PULMON MED
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2009
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Asthma and Obstructive Sleep Apnea (OSA) - A Pilot Study of the Effects of OSA and Its Treatment on Asthma
- ClinicalTrials.gov ID
- NCT01026298
- Acronym / sponsor ID
- 2012-1038
- Conditions
- Asthma, Obstructive Sleep Apnea
- Keywords
- asthma, obstructive sleep apnea, severe asthma, OSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Mar 2007 (actual)
- Primary completion
- 7 May 2012 (actual)
- Study completion
- 25 Jun 2012 (actual)
- First posted
- 4 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is a common but under-diagnosed form of sleep disordered breathing (SDB). Asthma is a common disease with rising prevalence, which continues to pose significant morbidity and costs. In spite of considerable progress in our understanding of asthma, a large number of individuals with asthma continue to have symptoms and subsequently, have a poor functional status, poor quality of life and increased health care costs. In many cases no apparent cause is found and optimal therapy does not achieve its goal. While recent data suggests that OSA is common in severe asthma, the prevalence of OSA and its predisposing factors have not been studied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –8 weeks, no intervention for OSA |
| CPAP group | Active comparator | Other: FDA-Approved Treatment8-week randomized-controlled period of CPAP treatment |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- presence of not well-controlled (NWC) asthma (National Asthma Education and Prevention Program Guidelines step 2, 3, 4), as diagnosed by an asthma physician
- stable doses of standard therapy for 2 months prior to enrollment. These regimens will include: inhaled corticosteroids (ICS) for mild-persistent step; ICS and inhaled long-acting β-adrenergics (LABA) or ICS and leukotriene modifier (LTMs) agents for moderate-persistent step; high doses of ICS, LABA or LTMs, with or without oral steroids at stable doses, for patients in severe step
- adherence to the current asthma medications regimen, demonstration of a proper inhaler technique; agreement for maintaining the same asthma regimen (except rescue bronchodilators) as clinical condition permits (if an exacerbation occurs during the first 4-week period, the subject will be excluded as discussed below), and willingness to complete diaries of asthma symptoms, rescue bronchodilator use, peak flow meter (PEF) recordings as well as asthma-related urgent doctor's and emergency room visits and hospitalizations for the 3 months duration of the study
- moderate to high probability for OSA (SA-SDQ scores ≥31 for males and ≥28 for females) or high clinical suspicion for OSA
- preliminary agreement to treatment with continuous positive airway pressure (CPAP) if OSA is identified and current CPAP treatment criteria are met [patients with moderate to severe OSA (AHI>15 events/hour), patients with mild OSA (AHI 5-15 events/hour) in association with EDS or co-morbid conditions (HTN, stable ischemic heart disease, prior stroke, impaired cognition, mood disorders, insomnia
Key exclusion criteria (13 listed)
- asthma exacerbation in the prior 2 months
- acute sinusitis
- poorly controlled rhinitis or gastroesophageal reflux disease (GERD)
- any unstable medical or psychiatric illness likely to impede participation in the protocol during the next year
- evidence of co-existent lung disease, in particular allergic broncho-pulmonary aspergillosis or chronic obstructive pulmonary disease (COPD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDA-Approved Treatment8 weeks of treatment with Continuous Positive Airway Pressure (CPAP) | Other | CPAP group |
Primary outcome
To determine the prevalence and risk factors for OSA symptoms in a specialty clinic-based sample of individuals with asthma.
Time frame: 7 days
2 secondary outcomes
To assess changes in subjective and objective asthma measures in subjects with asthma and co-morbid OSA, after 8 weeks of treatment with continuous positive airway pressure (CPAP) versus no intervention (control).
Time frame: 56 days
To examine whether 8 weeks of CPAP for OSA improves quality of life, insomnia, daytime sleepiness and fatigue, and health resource utilization in individuals with asthma.
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihaela Teodorescu, MD principal investigator
UW Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDA-Approved Treatment in people with Asthma and Obstructive Sleep Apnea, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prevalence and risk factors for OSA symptoms in a specialty clinic-based sample of individuals with asthma. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.