Trial Outcomes & Findings for Progression of Airway Obstruction in Childhood Asthma (NCT NCT00873873)
NCT ID: NCT00873873
Last Updated: 2020-10-22
Results Overview
Segmental average airway wall thickness
COMPLETED
55 participants
Measured at Year 2
2020-10-22
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
8
|
9
|
18
|
|
Overall Study
COMPLETED
|
20
|
8
|
9
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Progression of Airway Obstruction in Childhood Asthma
Baseline characteristics by cohort
| Measure |
Persistent Obstruction
n=20 Participants
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.
|
Late Obstruction in Pulmonary Physiology
n=8 Participants
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.
|
Late Normal in Pulmonary Physiology
n=9 Participants
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.
|
Persistent Normal in Pulmonary Physiology
n=18 Participants
This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
46 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
20.0 years
STANDARD_DEVIATION 2.1 • n=99 Participants
|
18.9 years
STANDARD_DEVIATION 2.0 • n=107 Participants
|
20.8 years
STANDARD_DEVIATION 2.4 • n=206 Participants
|
19.9 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
20.0 years
STANDARD_DEVIATION 2.1 • n=31 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
8 participants
n=107 Participants
|
9 participants
n=206 Participants
|
18 participants
n=7 Participants
|
55 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Measured at Year 2Population: There were 43 participants with Chest CT data; 1 was excluded from the analysis due to incidental finding of an anatomical congenital anomaly.
Segmental average airway wall thickness
Outcome measures
| Measure |
Persistent Obstruction
n=15 Participants
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.
|
Late Obstruction
n=7 Participants
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.
|
Late Normal
n=8 Participants
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.
|
Persistent Normal
n=12 Participants
This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
|
|---|---|---|---|---|
|
Airway Wall Thickness
|
1.5 mm
Standard Deviation 0.2
|
1.5 mm
Standard Deviation 0.2
|
1.4 mm
Standard Deviation 0.1
|
1.6 mm
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Measured at Year 2Population: 54 participants had induced sputum data but 1 was excluded due to congenital anatomical anomaly (bronchial atresia).
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.
Outcome measures
| Measure |
Persistent Obstruction
n=19 Participants
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.
|
Late Obstruction
n=7 Participants
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.
|
Late Normal
n=9 Participants
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.
|
Persistent Normal
n=18 Participants
This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
|
|---|---|---|---|---|
|
Protease/Antiprotease
|
34.1 ratio
Standard Deviation 58.8
|
29.3 ratio
Standard Deviation 31.3
|
9.9 ratio
Standard Deviation 8.4
|
12.1 ratio
Standard Deviation 9.0
|
Adverse Events
Persistent Obstruction
Late Obstruction in Pulmonary Physiology
Late Normal in Pulmonary Physiology
Persistent Normal in Pulmonary Physiology
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Head, Pediatric Clinical Pharmacology
National Jewish Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place