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| ID | Type | Description | Link |
|---|---|---|---|
| 0405-16 |
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Key investigator resigned
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We hypothesize that the nocturnal use of continuous positive airway pressure in adults and children with asthma will decrease airway reactivity.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP | Experimental | Subjects will use CPAP of 8-12 during days 2 through 6 of the study. |
|
| SHAM | Sham Comparator | Subjects will use sham CPAP of 0-2 during days 2 through 6 of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP-Continuous Positive Airway Pressure | Device | Cpap will be worn at night by subjects 6 to 7 days duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 to 10 nights after cpap is started. |
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Inclusion Criteria:
Inclusion criteria for children 8-18
Inclusion criteria adults 18-60
Exclusion Criteria:
Exclusions for Children category age 8-18 include:
Exclusions for adults 18-60 include:
Exclusions/Inclusion criteria for adults with asthma include:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S. Tepper, MD, PhD | Indiana University | Principal Investigator |
| Mike Busk, MD | NIFS/ Indiana University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22835615 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Positivie Airway Pressure | Adult with stable asthma and normal spirometry used CPAP with a mask pressure between 8 and 10 cm H20 for 7 to 10 nights prior to the follow-up assessment. |
| FG001 | Sham Treatment | Adults with stable asthma and normal spirometry used SHAM with a mask pressure Mask pressure between 0 and 2 cm H20 for 7 to 10 nights prior to the follow-up assessment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CPAP | Subjects used CPAP set at 8-10 cmH20 for 7-10 nights. |
| BG001 | Sham | Subjects used SHAM set at 0-2 cmH20 for 7-10 nights |
| 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 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. | Posted | Mean | Standard Error | log mg/ml | 7 to 10 nights after cpap is started. |
|
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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 | Continuous Positive Airway Pressure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Tepper, MD, Ph.D. | Indiana University | 317-274-9647 | rtepper@iu.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D012891 | Sleep Apnea Syndromes |
| 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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| SHAM | Device | SHAM will be worn at night by subjects 6 to 7 days duration. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Sham | 0 | 9 | 0 | 9 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |