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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) (BADGER)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
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;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: fluticasone propionate + montelukast
Drug: fluticasone propionate
Drug: fluticasone propionate + salmeterol

  Participant Flow
  Hide 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
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 
Other                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 
Other                0                0                0                1                0                0 



  Baseline Characteristics
  Hide 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
All Participants All participants randomized to the six crossover sequences

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.  

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

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

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

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 reported.   Anticipated Reporting Date:   No text entered.  

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

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

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

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

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

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

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

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

15.  Secondary:   Adverse Events   [ Time Frame: Measured during each 16-week treatment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide 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
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 ( 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 )
Study First Received: October 31, 2006
Results First Received: May 17, 2010
Last Updated: February 24, 2013