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Trial record 1 of 2 for:    11027739 [PUBMED-IDS]
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Progression of Airway Obstruction in Childhood Asthma

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ClinicalTrials.gov Identifier: NCT00873873
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : January 6, 2012
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Asthma
Enrollment 55
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Persistent Obstruction Late Obstruction in Pulmonary Physiology Late Normal in Pulmonary Physiology Persistent Normal in Pulmonary Physiology
Hide Arm/Group Description 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. 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. 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. This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
Period Title: Overall Study
Started 20 8 9 18
Completed 20 8 9 18
Not Completed 0 0 0 0
Arm/Group Title Persistent Obstruction Late Obstruction in Pulmonary Physiology Late Normal in Pulmonary Physiology Persistent Normal in Pulmonary Physiology Total
Hide Arm/Group Description 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. 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. 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. This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later. Total of all reporting groups
Overall Number of Baseline Participants 20 8 9 18 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 8 participants 9 participants 18 participants 55 participants
<=18 years
3
  15.0%
2
  25.0%
1
  11.1%
3
  16.7%
9
  16.4%
Between 18 and 65 years
17
  85.0%
6
  75.0%
8
  88.9%
15
  83.3%
46
  83.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 8 participants 9 participants 18 participants 55 participants
20.0  (2.1) 18.9  (2.0) 20.8  (2.4) 19.9  (2.0) 20.0  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 8 participants 9 participants 18 participants 55 participants
Female
8
  40.0%
2
  25.0%
6
  66.7%
11
  61.1%
27
  49.1%
Male
12
  60.0%
6
  75.0%
3
  33.3%
7
  38.9%
28
  50.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 8 participants 9 participants 18 participants 55 participants
20 8 9 18 55
1.Primary Outcome
Title Airway Wall Thickness
Hide Description Segmental average airway wall thickness
Time Frame Measured at Year 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 43 participants with Chest CT data; 1 was excluded from the analysis due to incidental finding of an anatomical congenital anomaly.
Arm/Group Title Persistent Obstruction Late Obstruction Late Normal Persistent Normal
Hide Arm/Group Description:
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.
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.
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.
This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
Overall Number of Participants Analyzed 15 7 8 12
Mean (Standard Deviation)
Unit of Measure: mm
1.5  (0.2) 1.5  (0.2) 1.4  (0.1) 1.6  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Persistent Obstruction, Late Obstruction, Persistent Normal
Comments Is there a difference in airway wall thickness among the 4 groups?
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Protease/Antiprotease
Hide Description

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.

Time Frame Measured at Year 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
54 participants had induced sputum data but 1 was excluded due to congenital anatomical anomaly (bronchial atresia).
Arm/Group Title Persistent Obstruction Late Obstruction Late Normal Persistent Normal
Hide Arm/Group Description:
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.
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.
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.
This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
Overall Number of Participants Analyzed 19 7 9 18
Mean (Standard Deviation)
Unit of Measure: ratio
34.1  (58.8) 29.3  (31.3) 9.9  (8.4) 12.1  (9.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Persistent Obstruction Late Obstruction in Pulmonary Physiology Late Normal in Pulmonary Physiology Persistent Normal in Pulmonary Physiology
Hide Arm/Group Description 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. 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. 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. This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
All-Cause Mortality
Persistent Obstruction Late Obstruction in Pulmonary Physiology Late Normal in Pulmonary Physiology Persistent Normal in Pulmonary Physiology
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Persistent Obstruction Late Obstruction in Pulmonary Physiology Late Normal in Pulmonary Physiology Persistent Normal in Pulmonary Physiology
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/7 (0.00%)   0/9 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Persistent Obstruction Late Obstruction in Pulmonary Physiology Late Normal in Pulmonary Physiology Persistent Normal in Pulmonary Physiology
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/7 (0.00%)   0/9 (0.00%)   0/18 (0.00%) 
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.