Trial record 1 of 1 for:    NCT00395304
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Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00395304
First received: October 31, 2006
Last updated: February 24, 2013
Last verified: February 2013
Results First Received: May 17, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: fluticasone propionate + montelukast
Drug: fluticasone propionate
Drug: fluticasone propionate + salmeterol

  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
2xICS, 1xICS + LABA, 1xICS + LTRA Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
2xICS, 1xICS + LTRA, 1xICS + LABA Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
1xICS +LABA, 2xICS, 1xICS + LTRA Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
1xICS + LABA, 1xICS + LTRA, 2xICS Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
1xICS + LTRA, 2xICS, 1xICS + LABA Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
1xICS + LTRA, 1xICS + LABA, 2xICS Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)

Participant Flow for 3 periods

Period 1:   Treatment Period 1
    2xICS, 1xICS + LABA, 1xICS + LTRA     2xICS, 1xICS + LTRA, 1xICS + LABA     1xICS +LABA, 2xICS, 1xICS + LTRA     1xICS + LABA, 1xICS + LTRA, 2xICS     1xICS + LTRA, 2xICS, 1xICS + LABA     1xICS + LTRA, 1xICS + LABA, 2xICS  
STARTED     31     30     30     31     28     32  
COMPLETED     30     26     30     28     27     30  
NOT COMPLETED     1     4     0     3     1     2  
Withdrawal by Subject                 0                 3                 0                 2                 1                 1  
Lost to Follow-up                 1                 0                 0                 1                 0                 1  
Physician Decision                 0                 1                 0                 0                 0                 0  

Period 2:   Treatment Period 2
    2xICS, 1xICS + LABA, 1xICS + LTRA     2xICS, 1xICS + LTRA, 1xICS + LABA     1xICS +LABA, 2xICS, 1xICS + LTRA     1xICS + LABA, 1xICS + LTRA, 2xICS     1xICS + LTRA, 2xICS, 1xICS + LABA     1xICS + LTRA, 1xICS + LABA, 2xICS  
STARTED     30     26     30     28     27     30  
COMPLETED     30     22     29     27     27     28  
NOT COMPLETED     0     4     1     1     0     2  
Withdrawal by Subject                 0                 0                 0                 1                 0                 2  
Lost to Follow-up                 0                 3                 0                 0                 0                 0  
Physician Decision                 0                 0                 1                 0                 0                 0  
Unknown                 0                 1                 0                 0                 0                 0  

Period 3:   Treatment Period 3
    2xICS, 1xICS + LABA, 1xICS + LTRA     2xICS, 1xICS + LTRA, 1xICS + LABA     1xICS +LABA, 2xICS, 1xICS + LTRA     1xICS + LABA, 1xICS + LTRA, 2xICS     1xICS + LTRA, 2xICS, 1xICS + LABA     1xICS + LTRA, 1xICS + LABA, 2xICS  
STARTED     30     22     29     27     27     28  
COMPLETED     29     20     29     25     27     27  
NOT COMPLETED     1     2     0     2     0     1  
Withdrawal by Subject                 0                 0                 0                 1                 0                 1  
Lost to Follow-up                 1                 1                 0                 0                 0                 0  
Physician Decision                 0                 1                 0                 0                 0                 0  
Unknown                 0                 0                 0                 1                 0                 0  



  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
All Participants All participants randomized to the six crossover sequences

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  182  
Age  
[units: participants]
 
<=18 years     182  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  10.8  ± 2.7  
Gender  
[units: participants]
 
Female     63  
Male     119  
Region of Enrollment  
[units: participants]
 
United States     182  



  Outcome Measures

1.  Primary:   The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1.   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]

2.  Secondary:   Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Post-bronchodilator Forced FEV1   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Forced Vital Capacity (FVC)   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   FEV1/FVC   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Morning Peak Expiratory Flow Rate (PEFR)   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Evening PEFR   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   PEFR Variability   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Impulse Oscillometry   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Methacholine PC20   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Exhaled Nitric Oxide   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Asthma Control Test   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Asthma Quality of Life   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Time Until First Asthma Exacerbation   [ Time Frame: Measured during the last 12 weeks of each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

15.  Secondary:   Adverse Events   [ Time Frame: Measured during each 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  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.


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
The study was not designed or powered to evaluate the long-term safety of long-acting beta-agonists in children. The duration of the trial and its sample size preclude statements regarding long-term risks.  


Results Point of Contact:  
Name/Title: Vernon M. Chinchilli
Organization: Penn State Hershey 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: NCT00395304     History of Changes
Other Study ID Numbers: 444, 5U10HL064313, 5U10HL064288, 5U10HL064305, 5U10HL064295, 5U10HL064287, 5U10HL064307
Study First Received: October 31, 2006
Results First Received: May 17, 2010
Last Updated: February 24, 2013
Health Authority: United States: Federal Government