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CompletedNCT01026298Updated Dec 4, 2019

Asthma and Obstructive Sleep Apnea (OSA)

An interventional study of FDA-Approved Treatment in Asthma and Obstructive Sleep Apnea, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 73 Years. Per ClinicalTrials.gov, last updated 2019-12-04.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Mar 2007, registered Dec 2009).
Phase
Not applicable
Study type
Interventional
Enrollment
744
Allocation
Randomized
Ages
18 Years to 73 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Asthma
  • Obstructive Sleep Apnea

Keywords

  • asthma
  • obstructive sleep apnea
  • severe asthma
  • OSA
03

In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 744 is above the median of 83 across 2,814 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 73 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
744 participants (actual)

Study arms

  • No intervention
    Control Group

    8 weeks, no intervention for OSA

  • Active comparator
    CPAP group

    8-week randomized-controlled period of CPAP treatment

    Other: FDA-Approved Treatment

Interventions

  • OtherFDA-Approved Treatment

    8 weeks of treatment with Continuous Positive Airway Pressure (CPAP)

06

What researchers measure

Primary outcomes

  1. To determine the prevalence and risk factors for OSA symptoms in a specialty clinic-based sample of individuals with asthma.

    Time frame: 7 days

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 site
  • Univeristy of Wisconsin Hospital and Clinics
    Madison, Wisconsin 53792, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2007 to primary completion in May 2012, 62 months.

Of 466 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 47. This study's 62 months is above that.

Counting every sponsor, half of 502 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 2, 2009
First posted
Dec 4, 2009
StartActual
Mar 2007
Primary completionActual
May 7, 2012
CompletionActual
Jun 25, 2012
Last update
Dec 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01026298
Responsible party
Sponsor
First posted
Dec 4, 2009
Start date
Mar 2007
Primary completion
May 7, 2012
Completion
Jun 25, 2012
Last update
Dec 4, 2019

Study contacts

Mihaela Teodorescu, MD
principal investigator · UW Madison

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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