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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Persistent Obstruction   Late Obstruction in Pulmonary Physiology   Late Normal in Pulmonary Physiology   Persistent Normal in Pulmonary Physiology
STARTED   20   8   9   18 
COMPLETED   20   8   9   18 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Persistent Obstruction   Late Obstruction in Pulmonary Physiology   Late Normal in Pulmonary Physiology   Persistent Normal in Pulmonary Physiology   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   8   9   18   55 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 20.0  (2.1)   18.9  (2.0)   20.8  (2.4)   19.9  (2.0)   20.0  (2.1) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
         
United States   20   8   9   18   55 


  Outcome Measures

1.  Primary:   Airway Wall Thickness   [ Time Frame: Measured at Year 2 ]

2.  Secondary:   Protease/Antiprotease   [ Time Frame: Measured at Year 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information