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| ID | Type | Description | Link |
|---|---|---|---|
| R21HL087811-01 | 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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Distinct patterns of loss in pulmonary function were identified in children with mild to moderate asthma participating in a 10-year observation period during the NHLBI Childhood Asthma Management Program. This loss in pulmonary function is likely related to ongoing inflammation unresponsive to current therapy. This study will measure indicators of airway inflammation which are associated with structural and physiologic changes in the lung and provide insight into mechanisms of asthma progression in adolescence and early adulthood.
The Childhood Asthma Management Program Continuation Study/Phase 2 is a 3.25 year observational follow-up study of the children enrolled in the Childhood Asthma Management Program (CAMP) randomized trial. CAMPCS/2 is a multicenter National Heart, Lung and Blood Institute program. The objective of the CAMPCS/2 is to determine the consequences of childhood asthma and its treatment on asthma outcomes in young adulthood. This separate ancillary study will extend the core CAMP/CAMPCS work by focusing on progression of airway obstruction in childhood asthma to evaluate mechanisms of progression and describe the differences in the four separate patterns in airway obstruction that have evolved over time. The four patterns of airway obstruction which have been identified are as follows: (1) abnormal obstruction present in early childhood which remained abnormal (Low/Low group) and (2) initially normal ratios, which worsened into the abnormal range over time (Normal/Low group). These patterns with unfavorable outcomes can be compared to two other patterns with favorable outcomes: (3) initially abnormal ratios improving with time (Low/Normal group) and (4) normal ratios throughout follow-up (Normal/Normal group).
Based on these four patterns, three specific hypotheses related to immunology, structure, and physiology are identified:
Each participant will be studied at varying times over the 2-year study period. Researchers will complete a collection of sputum, blood, urine, and exhaled breath condensate samples; exhaled nitric oxide; and spirometry from CAMPCS/3 participants, representing each of the four phenotypes (n = 20 for a total of 80).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persistent obstruction | (pattern of asthma progression) | ||
| Late obstruction | (pattern of asthma progression) | ||
| Late normal | (pattern of asthma progression) | ||
| Persistent normal | (pattern of asthma progression) |
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| Measure | Description | Time Frame |
|---|---|---|
| Airway Wall Thickness | Segmental average airway wall thickness | Measured at Year 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Protease/Antiprotease | MMP9/TIMP 1 molar ratio MMP9 is matrix metalloproteinse 9 and is a protease enzyme that is responsible for tissue degradation of extracellular matrix and could be a factor in airway remodeling. TIMP 1 is an abbreviation for tissue inhibitor of metalloproteinase-1 and is an inhibitor of MMP9 and would serve to balance the activity protease activity of MMP9 and this it is an anti-protease. Therefore the ratio of MMP9 and TIMP1 is used to assess the relative balance of protease and antiprotease activity. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants enrolled in CAMPCS/3 from various CAMP sites will be invited to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Stanley J. Szefler, MD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11027739 | Background | Childhood Asthma Management Program Research Group; Szefler S, Weiss S, Tonascia J, Adkinson NF, Bender B, Cherniack R, Donithan M, Kelly HW, Reisman J, Shapiro GG, Sternberg AL, Strunk R, Taggart V, Van Natta M, Wise R, Wu M, Zeiger R. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med. 2000 Oct 12;343(15):1054-63. doi: 10.1056/NEJM200010123431501. | |
| 15028558 | Background | Covar RA, Spahn JD, Murphy JR, Szefler SJ; Childhood Asthma Management Program Research Group. Progression of asthma measured by lung function in the childhood asthma management program. Am J Respir Crit Care Med. 2004 Aug 1;170(3):234-41. doi: 10.1164/rccm.200308-1174OC. Epub 2004 Mar 17. |
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Analysis of serial pulmonary function measures in participants in CAMP and CAMPCS over time showed 4 patterns of airway obstruction developing during childhood and adolescence based on measurements of pre-bronchodilator FEV1/FVC at the time of enrollment in CAMP and again at the end of the observational phase.
The NHLBI Childhood Asthma Management Program (CAMP) and CAMP Continuation Studies afforded a unique opportunity to investigate four newly described, distinct patterns of airway obstruction associated with childhood asthma, including two that have been associated with significant and potentially irreversible loss in pulmonary function.
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| ID | Title | Description |
|---|---|---|
| FG000 | Persistent Obstruction | This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later. |
| FG001 | Late Obstruction in Pulmonary Physiology | This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later. |
| FG002 | Late Normal in Pulmonary Physiology | This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP. |
| FG003 | Persistent Normal in Pulmonary Physiology | This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Persistent Obstruction | This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later. |
| BG001 | Late Obstruction in Pulmonary Physiology |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Airway Wall Thickness | Segmental average airway wall thickness | There were 43 participants with Chest CT data; 1 was excluded from the analysis due to incidental finding of an anatomical congenital anomaly. | Posted | Mean | Standard Deviation | mm | Measured at Year 2 |
|
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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 | Persistent Obstruction | This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later. |
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We had planned to extend invitations to the remaining 55 participants in a streamlined version of this protocol after analyzing the preliminary data and an additional cycle of CAMP was funded in 2007.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, Pediatric Clinical Pharmacology | National Jewish Health | 303-398-1193 | szeflers@njhealth.org |
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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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Induced sputum, urine, blood, and exhaled breath condensates
| Measured at Year 2 |
| 17088127 | Background | Strunk RC, Weiss ST, Yates KP, Tonascia J, Zeiger RS, Szefler SJ; CAMP Research Group. Mild to moderate asthma affects lung growth in children and adolescents. J Allergy Clin Immunol. 2006 Nov;118(5):1040-7. doi: 10.1016/j.jaci.2006.07.053. |
This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later. |
| BG002 | Late Normal in Pulmonary Physiology | This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP. |
| BG003 | Persistent Normal in Pulmonary Physiology | This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Late Normal | This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP. |
| OG003 | Persistent Normal | This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later. |
|
|
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| Secondary | Protease/Antiprotease | MMP9/TIMP 1 molar ratio MMP9 is matrix metalloproteinse 9 and is a protease enzyme that is responsible for tissue degradation of extracellular matrix and could be a factor in airway remodeling. TIMP 1 is an abbreviation for tissue inhibitor of metalloproteinase-1 and is an inhibitor of MMP9 and would serve to balance the activity protease activity of MMP9 and this it is an anti-protease. Therefore the ratio of MMP9 and TIMP1 is used to assess the relative balance of protease and antiprotease activity. | 54 participants had induced sputum data but 1 was excluded due to congenital anatomical anomaly (bronchial atresia). | Posted | Mean | Standard Deviation | ratio | Measured at Year 2 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Late Obstruction in Pulmonary Physiology | This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later. | 0 | 7 | 0 | 7 |
| EG002 | Late Normal in Pulmonary Physiology | This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP. | 0 | 9 | 0 | 9 |
| EG003 | Persistent Normal in Pulmonary Physiology | This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later. | 0 | 18 | 0 | 18 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |