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(CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA) (TREXA)

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ClinicalTrials.gov Identifier: NCT00394329
Recruitment Status : Completed
First Posted : November 1, 2006
Results First Posted : May 17, 2013
Last Update Posted : May 24, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center

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

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

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]
Count of Participants
         
<=18 years      71 100.0%      72 100.0%      71 100.0%      74 100.0%      288 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      32  45.1%      30  41.7%      34  47.9%      33  44.6%      129  44.8% 
Male      39  54.9%      42  58.3%      37  52.1%      41  55.4%      159  55.2% 
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:   Change Between Week 44 and Week 0 in the Asthma Control Days   [ Time Frame: An asthma control day was determined daily during each of the 44-week treatment periods. The primary analysis constructed the change between week 14 and week 0. ]

3.  Secondary:   Change Between Week 44 and Week 0 in Rescue Albuterol Puffs Per Day   [ Time Frame: Rescue albuterol puffs were measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. ]

4.  Secondary:   Change Between Week 44 and Week 0 in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV!)   [ Time Frame: Pre-bronchodilator FEV1 was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. ]

5.  Secondary:   Change Between Week 44 and Week 0 in the Morning Peak Expiratory Flow Rate (PEFR)   [ Time Frame: Morning PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. ]

6.  Secondary:   Change Between Week 44 and Week 0 in the Evening Peak Expiratory Flow Rate Variability (PEFR)   [ Time Frame: Evening PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. ]

7.  Secondary:   Change Between Week 44 and Week 0 Peak Expiratory Flow Rate (PEFR) Variability   [ Time Frame: PEFR variability was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. ]

8.  Secondary:   Change Between Week 44 and Week 0 in the Exhaled Nitric Oxide (eNO) Measured in Parts Per Billion   [ Time Frame: eNO was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. ]

9.  Secondary:   Change Between Week 44 and Week 0 in the Asthma-specific Quality of Life Assessment   [ Time Frame: The asthma-specific quality of life assessment was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. ]

10.  Secondary:   Change Between Week 44 and Week 0 in the Asthma Control Test (ACT)   [ Time Frame: The ACT was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0. ]


  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
No text entered.


  More Information

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 24, 2018