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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL048522 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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. We believe that use of CPAP may be a treatment for children with asthma.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | Experimental | Use of a CPAP machine for at least 5 days per week for 28 days |
|
| Continuous Positive Airway Pressure (CPAP) Sham | Sham Comparator | Use of a sham CPAP machine for at least 5 days per week for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline (visit 1) and 4 weeks (visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline (visit 1) and 4 weeks (visit 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Tepper, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30444283 | Derived | 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. |
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25 were excluded based on screening criteria, two subjects (one in each group) were lost to follow-up, two (one in each group) did not tolerate the equipment and two (one in each group) did not undergo Methacholine challenge at V2 due to the presence of asthma symptoms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Positive Airway Pressure (CPAP) | Use of a CPAP machine for at least 5 days per week for 28 days 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. |
| FG001 | Continuous Positive Airway Pressure (CPAP) Sham | Use of a sham CPAP machine for at least 5 days per week for 28 days CPAP Sham: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CPAP | Use of a CPAP machine for at least 5 days per week for 28 days 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. |
| BG001 | CPAP Sham |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One subject in each group did not undergo Methacholine challenge at V2 due to the presence of asthma symptoms | Posted | Mean | Standard Deviation | mg/mL | baseline (visit 1) and 4 weeks (visit 2) |
|
4 weeks
Adverse event were described as an asthma exacerbation requiring oral corticosteroids during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CPAP | Use of a CPAP machine for at least 5 days per week for 28 days 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asthma exacerbation treated with oral corticosteroids | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina Tiller | Indiana University | 317-044-4522 | ctiller@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2016 | Dec 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Continuous Positive Airway Pressure (CPAP) Sham | Device | 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. |
|
Use of a sham CPAP machine for at least 5 days per week for 28 days CPAP Sham: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Methacholine Bronchial Challenge | 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 forced expiratory volume at one second (FEV1) decreased by 20% or Methacholine concentration of 16 mg/mL was inhaled. | Mean | Standard Deviation | mg/mL |
|
| OG001 | CPAP Sham | Use of a sham CPAP machine for at least 5 days per week for 28 days CPAP Sham: 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. |
|
|
| Secondary | 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. | The overall success rate in obtaining quality sputum samples was 57%; however, only 10 CPAP and 12 sham subjects had quality samples at both study visits. | Posted | Mean | Standard Deviation | Percentage of sputum eosinophils | baseline (visit 1) and 4 weeks (visit 2) |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 5 |
| 29 |
| EG001 | CPAP Sham | Use of a sham CPAP machine for at least 5 days per week for 28 days CPAP Sham: 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. | 0 | 30 | 0 | 30 | 3 | 30 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012138 |
| Respiratory Therapy |