AsthmaNCT02396849

Modulation Of Airway Reactivity With Chronic Mechanical Strain

A study testing Continuous Positive Airway Pressure (CPAP) in people with Asthma, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to see if the use of a machine called CPAP will help children with asthma breathe better. CPAP is a machine that produces airflow to help people with breathing problems. To use it, you will wear a mask connected by a hose to the CPAP machine. Read more about this study

Who is it for?: Ages 8 to 17 years
Conditions the study is for: Asthma
What is being tested?: Continuous Positive Airway Pressure (CPAP)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 1 siteUnited States
Study dates: Jan 2015to 9 Jan 2020
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 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children 8-17 yrs olds with severe asthma (N=120) will be recruited from the Pediatric High Risk Asthma Clinic and Pulmonary Clinics at Riley Hospital for Children at Indiana University Health.
Severe asthma will be defined by the need for medication therapies following steps 4-6 according to the National Institutes of Health's Asthma Care Quick Reference, September 2012 or high dose of inhaled corticosteroids
On a stable regimen of asthma medications for at least 8 weeks prior to enrollment without systemic corticosteroids for ≥ 4 weeks

Who cannot join

Obese (>95% predicted BMI)
Congenital heart disease or chronic lung disease
History of pneumothorax
Inability to perform pulmonary function testing
Oxygen saturation <93%
forced expiratory volume at one second (FEV1) <70% predicted
Provocative concentration causing a 20% drop in FEV1 from baseline (PC20) ≥16 mg/ml of methacholine.

Trial locations and contacts

1 site in 1 country.

United States1 site

Riley Hospital for Children
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Read the detailed description

During the previous funding period of this project, our laboratory demonstrated that chronic mechanical strain imposed on the airways in vivo using continuous positive airway pressure (CPAP) results in a dramatic reduction in airway reactivity in vivo in mice, ferrets and rabbits1-3. Lungs, airways and airway smooth muscle (ASM) tissues isolated from CPAP-treated animals studied in vitro exhibited lower responsiveness to bronchoconstrictors1-3. We also observed this suppression of airway responsiveness by chronic mechanical strain in a rabbit model of allergic asthma5. These animal studies led to a small clinical trial in which adults with asthma were treated with nocturnal CPAP for 1 week. CPAP caused a significant reduction in airway reactivity in these patients6. This novel approach for treating airway hyper-reactivity is currently being evaluated in a NIH multi-center Phase II clinical trial of adults with mild to moderate asthma (U01 HL108730).

Conditions: Asthma
Being tested: Continuous Positive Airway Pressure (CPAP), Continuous Positive Airway Pressure (CPAP) Sham
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Continuous Positive Airway Pressure (CPAP)Device
Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
Continuous Positive Airway Pressure (CPAP) ShamDevice
Subjects assigned to this group will be asked to use the CPAP Sham machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.

Study groups in NCT02396849
Study group	Role	What they receive
Continuous Positive Airway Pressure (CPAP)	Experimental	Use of a CPAP machine for at least 5 days per week for 28 days Receives: Device: Continuous Positive Airway Pressure (CPAP)
Continuous Positive Airway Pressure (CPAP) Sham	Sham comparator	Use of a sham CPAP machine for at least 5 days per week for 28 days Receives: Device: Continuous Positive Airway Pressure (CPAP) Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2)
The change in airway reactivity measured prior to and after 4 weeks of either CPAP or SHAM treatment. Methacholine bronchial challenge was performed using the 5-breath protocol (DeVilbiss646 with KoKo dosimeter: 9 μL/breath) with quadrupling concentrations starting with 0.0625 mg/mL and continuing until FEV1 decreased by 20% (PC20) or Methacholine concentration of 16 mg/mL was inhaled.
Measured: baseline (visit 1) and 4 weeks (visit 2)

Secondary outcomes (1)

Change in Airway Inflammation From Baseline (Visit 1) and 4 Weeks (Visit 2)
Airway Inflammation assessed as the change in the percentage eosinophils in the induced sputum measured prior to and after 4 weeks of Continuous Positive Airway Pressure (CPAP) or sham CPAP treatment.
Measured: baseline (visit 1) and 4 weeks (visit 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 20159 Jan 2020

First posted24 Mar 2015 (estimated)
Study startJan 2015
Primary completion9 Jan 2020
Study completion9 Jan 2020

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02396849
Sponsor's protocol ID: 4689673
Other IDs: 5R01HL048522
Status last verified: Feb 2021
First submitted: 18 Mar 2015
Last updated: 9 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Praca E, Jalou H, Krupp N, Delecaris A, Hatch J, Slaven J, Gunst SJ, Tepper RS. Effect of CPAP on airway reactivity and airway inflammation in children with moderate-severe asthma. Respirology. 2019 Apr;24(4):338-344. doi: 10.1111/resp.13441. Epub 2018 Nov 16.
PubMed 30444283

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modulation Of Airway Reactivity With Chronic Mechanical Strain
ClinicalTrials.gov ID: NCT02396849
Acronym / sponsor ID: 4689673
Conditions: Asthma
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Jan 2015 (actual)
Primary completion: 9 Jan 2020 (actual)
Study completion: 9 Jan 2020 (actual)
First posted: 24 Mar 2015 (estimated)
Results: Posted 18 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Continuous Positive Airway Pressure (CPAP)	Experimental	Device: Continuous Positive Airway Pressure (CPAP)Use of a CPAP machine for at least 5 days per week for 28 days
Continuous Positive Airway Pressure (CPAP) Sham	Sham comparator	Device: Continuous Positive Airway Pressure (CPAP) ShamUse of a sham CPAP machine for at least 5 days per week for 28 days

Who may qualify

Ages: 8 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Children 8-17 yrs olds with severe asthma (N=120) will be recruited from the Pediatric High Risk Asthma Clinic and Pulmonary Clinics at Riley Hospital for Children at Indiana University Health.
Severe asthma will be defined by the need for medication therapies following steps 4-6 according to the National Institutes of Health's Asthma Care Quick Reference, September 2012 or high dose of inhaled corticosteroids
On a stable regimen of asthma medications for at least 8 weeks prior to enrollment without systemic corticosteroids for ≥ 4 weeks

Key exclusion criteria (7 listed)

Obese (>95% predicted BMI)
Congenital heart disease or chronic lung disease
History of pneumothorax
Inability to perform pulmonary function testing
Oxygen saturation <93%

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
Continuous Positive Airway Pressure (CPAP)Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.	Device	Continuous Positive Airway Pressure (CPAP)
Continuous Positive Airway Pressure (CPAP) ShamSubjects assigned to this group will be asked to use the CPAP Sham machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.	Device	Continuous Positive Airway Pressure (CPAP) Sham

Primary outcome

Change in Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2)
Time frame: baseline (visit 1) and 4 weeks (visit 2)
The change in airway reactivity measured prior to and after 4 weeks of either CPAP or SHAM treatment. Methacholine bronchial challenge was performed using the 5-breath protocol (DeVilbiss646 with KoKo dosimeter: 9 μL/breath) with quadrupling concentrations starting with 0.0625 mg/mL and continuing until FEV1 decreased by 20% (PC20) or Methacholine concentration of 16 mg/mL was inhaled.

1 secondary outcome

Change in Airway Inflammation From Baseline (Visit 1) and 4 Weeks (Visit 2)
Time frame: baseline (visit 1) and 4 weeks (visit 2)

Results and safety

Results posted to the registry on 18 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Continuous Positive Airway Pressure (CPAP)	29	27
Continuous Positive Airway Pressure (CPAP) Sham	30	28

Primary outcome: Change in Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2)

Time frame: baseline (visit 1) and 4 weeks (visit 2). Mean (Standard Deviation). Unit: mg/mL

Measure	CPAP n = 26	CPAP Sham n = 27
Visit 1	3.0 (4.6)	3.2 (4.4)
Visit 2	5.3 (8.9)	4.3 (6.8)

Population analysed: One subject in each group did not undergo Methacholine challenge at V2 due to the presence of asthma symptoms

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CPAP	0 of 29 (0%)	5 of 29 (17.2%)	0 of 29
CPAP Sham	0 of 30 (0%)	3 of 30 (10%)	0 of 30

Limitations and caveats (from the sponsor): We evaluated only children with moderate-severe asthma, the results cannot be extrapolated to children with mild or moderate asthma. A major limitation of our study was the limited number of subjects we could recruit from a single pediatric center. Our evaluation of airway inflammation was limited to induced sputum rather than bronchoalveolar lavage, which would not have been an acceptable risk in our children.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30444283Praca E, Jalou H, Krupp N, Delecaris A, Hatch J, Slaven J, Gunst SJ, Tepper RS. Effect of CPAP on airway reactivity and airway inflammation in children with moderate-severe asthma. Respirology. 2019 Apr;24(4):338-344. doi: 10.1111/resp.13441. Epub 2018 Nov 16.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
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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 Tepper, MD principal investigator

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 Continuous Positive Airway Pressure (CPAP) 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 7 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 9 Mar 2021. 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 18 Feb 2021). 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 Airway Reactivity From Baseline (Visit 1) and 4 Weeks (Visit 2) (time frame: baseline (visit 1) and 4 weeks (visit 2)). 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 NCT02396849, 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 9 Mar 2021.