AsthmaNCT00592631
Assessment Of The Effects Of Short and Long Term Use Of CPAP
A study testing CPAP-Continuous Positive Airway Pressure in people with Asthma, run by Indiana University at 1 site in United States.
Trial summary
We hypothesize that the nocturnal use of continuous positive airway pressure in adults and children with asthma will decrease airway reactivity. Read more about this study
- Who is it for?
- Ages 8 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- CPAP-Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children 8-18 years of age scheduled to start CPAP for obstructive sleep apnea.
- Subjects can have clinically stable asthma, with no plans by their physician to change asthma therapy over the next month
- Adults 18-60 years of age, seen in adult Pulmonary Clinic for sleep related problems who may require treatment with nocturnal continuous positive pressure (CPAP), which will be determined by polysomnography(PSG) will be approached to participate in the study.
Who cannot join
- Exclusions for Children category age 8-18 include:
- Cyanotic congenital heart disease.
- History of acute respiratory symptoms for 3 weeks prior to testing.
- Inability to perform pulmonary function testing adequately.
- Escalation in asthma medication at time of recruitment.
- SaO2 <93% while awake and breathing room air
Show all 22Show fewer
- Baseline FEV1 <75% predicted
- Exclusions for adults 18-60 include:
- Gastro-Esophageal Reflux requiring Medical management.
- Chronic Obstructive Pulmonary Disease.
- Use of Supplemental Oxygen.
- Ischemic Heart Disease or Hypertension requiring treatment with medications other than diuretics.
- Use of systemic corticosteroid therapy during the past 6 months.
- Acute Respiratory Illness in the previous 8 weeks.
- Exclusions/Inclusion criteria for adults with asthma include:
- Juniper Score <1.5
- Baseline FEV1 > or equal to 70%
- Non-smoking for 6 months
- Less than 10 pack year smoking history
- No change in asthma medications for the last 2 months
- Negative pregnancy test
- Subject cannot have sleep apnea
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Official title: Assessment of the Effects of Short and Long Term Use of Continuous Positive Airway Pressure on Airway Reactivity in Children and Adults With and Without Asthma
We hypothesize that the nocturnal use of continuous positive airway pressure in adults and children with asthma will decrease airway reactivity.
Read the detailed description
Deep inspirations have been shown to decrease the sensitivity of airways to narrowing (airway reactivity) after inhalation of agents that induce constriction of the bronchi in healthy adults. This response is absent in adult asthmatics; however, there is data demonstrating that use of continuous positive airway pressure (CPAP) for short periods of time may decrease airway reactivity in adult asthmatics. This suggests that although deep inspirations may not result in decreased airway reactivity, sustained lung inflation may lead to changes in asthmatic airway smooth muscle structure that lead to a decrease in airway reactivity. The purpose of our study is to determine whether short and long term use of CPAP in children and adults leads to decreased airway reactivity. If airway reactivity is decreased with CPAP, this may provide a novel therapeutic strategy for patients with asthma.
- Conditions
- Asthma
- Being tested
- CPAP-Continuous Positive Airway Pressure, SHAM
- Keywords
- asthma, sleep apnea
- Medical subject headings
- Asthma, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP-Continuous Positive Airway PressureDevice
Cpap will be worn at night by subjects 6 to 7 days duration.
SHAMDevice
SHAM will be worn at night by subjects 6 to 7 days duration.
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | Subjects will use CPAP of 8-12 during days 2 through 6 of the study. Receives: Device: CPAP-Continuous Positive Airway Pressure |
| SHAM | Sham comparator | Subjects will use sham CPAP of 0-2 during days 2 through 6 of the study. Receives: Device: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1)
Methacholine is an inhaled medication used to assess asthma and reactive airways. It was given at increasing concentrations (beginning with 0.0625 mg/ml and ending with 16.0 mg/ml). Each dose was followed by a lung measurement until a change of FEV1 of 20% occurs or until a maximum dose was reached, whichever came first.
Measured: 7 to 10 nights after cpap is started.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startFeb 2005
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Key investigator resigned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert S. Tepper, MD, PhD, Principal investigator, Indiana UniversityMike Busk, MD, Study director, NIFS/ Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592631
- Sponsor's protocol ID
- 0405-16
- Other IDs
- 0405-16
- Status last verified
- Jan 2016
- First submitted
- 2 Jan 2008
- Last updated
- 10 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Busk M, Busk N, Puntenney P, Hutchins J, Yu Z, Gunst SJ, Tepper RS. Use of continuous positive airway pressure reduces airway reactivity in adults with asthma. Eur Respir J. 2013 Feb;41(2):317-22. doi: 10.1183/09031936.00059712. Epub 2012 Jul 26.
PubMed 22835615
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Short and Long Term Use of Continuous Positive Airway Pressure on Airway Reactivity in Children and Adults With and Without Asthma
- ClinicalTrials.gov ID
- NCT00592631
- Acronym / sponsor ID
- 0405-16
- Conditions
- Asthma
- Keywords
- asthma, sleep apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Key investigator resigned
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Posted 10 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that the nocturnal use of continuous positive airway pressure in adults and children with asthma will decrease airway reactivity.
Detailed description
Deep inspirations have been shown to decrease the sensitivity of airways to narrowing (airway reactivity) after inhalation of agents that induce constriction of the bronchi in healthy adults. This response is absent in adult asthmatics; however, there is data demonstrating that use of continuous positive airway pressure (CPAP) for short periods of time may decrease airway reactivity in adult asthmatics. This suggests that although deep inspirations may not result in decreased airway reactivity, sustained lung inflation may lead to changes in asthmatic airway smooth muscle structure that lead to a decrease in airway reactivity. The purpose of our study is to determine whether short and long term use of CPAP in children and adults leads to decreased airway reactivity. If airway reactivity is decreased with CPAP, this may provide a novel therapeutic strategy for patients with asthma.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: CPAP-Continuous Positive Airway PressureSubjects will use CPAP of 8-12 during days 2 through 6 of the study. |
| SHAM | Sham comparator | Device: SHAMSubjects will use sham CPAP of 0-2 during days 2 through 6 of the study. |
Who may qualify
- Ages
- 8 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children 8-18 years of age scheduled to start CPAP for obstructive sleep apnea.
- Subjects can have clinically stable asthma, with no plans by their physician to change asthma therapy over the next month
- Adults 18-60 years of age, seen in adult Pulmonary Clinic for sleep related problems who may require treatment with nocturnal continuous positive pressure (CPAP), which will be determined by polysomnography(PSG) will be approached to participate in the study.
Key exclusion criteria (22 listed)
- Cyanotic congenital heart disease.
- History of acute respiratory symptoms for 3 weeks prior to testing.
- Inability to perform pulmonary function testing adequately.
- Escalation in asthma medication at time of recruitment.
- SaO2 <93% while awake and breathing room air
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 |
|---|---|---|
| CPAP-Continuous Positive Airway PressureCpap will be worn at night by subjects 6 to 7 days duration. | Device | CPAP |
| SHAMSHAM will be worn at night by subjects 6 to 7 days duration. | Device | SHAM |
Primary outcome
Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 7 to 10 nights after cpap is started.
Methacholine is an inhaled medication used to assess asthma and reactive airways. It was given at increasing concentrations (beginning with 0.0625 mg/ml and ending with 16.0 mg/ml). Each dose was followed by a lung measurement until a change of FEV1 of 20% occurs or until a maximum dose was reached, whichever came first.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22835615Busk M, Busk N, Puntenney P, Hutchins J, Yu Z, Gunst SJ, Tepper RS. Use of continuous positive airway pressure reduces airway reactivity in adults with asthma. Eur Respir J. 2013 Feb;41(2):317-22. doi: 10.1183/09031936.00059712. Epub 2012 Jul 26.
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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.
Robert S. Tepper, MD, PhD principal investigator
Indiana University
Mike Busk, MD study director
NIFS/ Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP-Continuous Positive Airway Pressure in people with Asthma, run by Indiana University 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 3 inclusion and 22 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: stopped early, as of the sponsor's last update on 10 Feb 2016. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1) (time frame: 7 to 10 nights after cpap is started.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00592631, which also lists 1 linked publication.
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 10 Feb 2016.