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Childhood Asthma Research and Education (CARE) Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA) (TREXA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00394329
First Posted: November 1, 2006
Last Update Posted: May 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
Results First Submitted: February 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Beclomethasone dipropionate
Drug: Albuterol sulfate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
A: Daily ICS + Rescue ICS

Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed

Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid

Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed

B: Daily ICS

Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid

Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

C: Rescue ICS

Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed

D: Placebo

Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed


Participant Flow:   Overall Study
    A: Daily ICS + Rescue ICS   B: Daily ICS   C: Rescue ICS   D: Placebo
STARTED   71   72   71   74 
COMPLETED   63   63   58   50 
NOT COMPLETED   8   9   13   24 



  Baseline Characteristics
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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
A: Daily ICS + Rescue ICS

Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed

Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid

Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed

B: Daily ICS

Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid

Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

C: Rescue ICS

Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed

D: Placebo

Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed

Total Total of all reporting groups

Baseline Measures
   A: Daily ICS + Rescue ICS   B: Daily ICS   C: Rescue ICS   D: Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 71   72   71   74   288 
Age 
[Units: Participants]
         
<=18 years   71   72   71   74   288 
Between 18 and 65 years   0   0   0   0   0 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 11.4  (3.1)   10.8  (3.5)   10.4  (2.8)   10.4  (3.2)   10.7  (3.2) 
Gender 
[Units: Participants]
         
Female   32   30   34   33   129 
Male   39   42   37   41   159 
Region of Enrollment 
[Units: Participants]
         
United States   71   72   71   74   288 


  Outcome Measures

1.  Primary:   Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy   [ Time Frame: Measured during the 44-week treatment period ]

2.  Secondary:   Asthma Control Days   [ Time Frame: Measured during the 44-week treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Albuterol Use   [ Time Frame: Measured during the 44-week treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Spirometry, Pre- and Post-bronchodilator   [ Time Frame: Measured during the 44-week treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Morning (AM) and Evening (PM) Peak Expiratory Flow Rate   [ Time Frame: Measured during the 44-week treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Peak Expiratory Flow Rate Variability   [ Time Frame: Measured during the 44-week treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Impulse Oscillometry   [ Time Frame: Measured during the 44-week treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Methacholine Provocative Concentration at 20% (PC20)   [ Time Frame: Measured during the 44-week treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Exhaled Nitric Oxide   [ Time Frame: Measured during the 44-week treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Asthma-specific Quality of Life Assessment   [ Time Frame: Measured during the 44-week treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   Asthma Control Test   [ Time Frame: Measured during the 44-week treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Secondary:   Adverse Events   [ Time Frame: Measured during the 44-week treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vernon M. Chinchilli, PhD
Organization: Penn State College of Medicine
phone: 717-531-4262
e-mail: vchinchi@psu.edu


Publications of Results:

Responsible Party: Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00394329     History of Changes
Other Study ID Numbers: 445
5U10HL064313 ( U.S. NIH Grant/Contract )
5U10HL064288 ( U.S. NIH Grant/Contract )
5U10HL064305 ( U.S. NIH Grant/Contract )
5U10HL064295 ( U.S. NIH Grant/Contract )
5U10HL064287 ( U.S. NIH Grant/Contract )
5U10HL064307 ( U.S. NIH Grant/Contract )
First Submitted: October 30, 2006
First Posted: November 1, 2006
Results First Submitted: February 24, 2013
Results First Posted: May 17, 2013
Last Update Posted: May 17, 2013