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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00394329
First received: October 30, 2006
Last updated: April 5, 2013
Last verified: April 2013
Results First Received: February 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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

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

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

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

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

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

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

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

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

12.  Secondary:   Adverse Events   [ Time Frame: Measured during the 44-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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
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  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, 5U10HL064288, 5U10HL064305, 5U10HL064295, 5U10HL064287, 5U10HL064307
Study First Received: October 30, 2006
Results First Received: February 24, 2013
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration