Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00495157
First received: June 28, 2007
Last updated: April 5, 2013
Last verified: April 2013
Results First Received: April 30, 2012  
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: Behavioral: Symptom-based adjustment
Behavioral: Biomarker-based adjustment
Behavioral: Guideline-based adjustment

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Symptom-based Adjustment Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Biomarker-based Adjustment Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Guideline-based Adjustment Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

Participant Flow:   Overall Study
    Symptom-based Adjustment     Biomarker-based Adjustment     Guideline-based Adjustment  
STARTED     113     115     114  
COMPLETED     97     92     101  
NOT COMPLETED     16     23     13  



  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.
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Reporting Groups
  Description
Symptom-based Adjustment Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Biomarker-based Adjustment Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Guideline-based Adjustment Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Total Total of all reporting groups

Baseline Measures
    Symptom-based Adjustment     Biomarker-based Adjustment     Guideline-based Adjustment     Total  
Number of Participants  
[units: participants]
  113     115     114     342  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     111     114     112     337  
>=65 years     2     1     2     5  
Age  
[units: years]
Mean ± Standard Deviation
  36.0  ± 12.2     34.8  ± 11.3     34.2  ± 11.9     35.0  ± 11.8  
Gender  
[units: participants]
       
Female     83     82     72     237  
Male     30     33     42     105  
Region of Enrollment  
[units: participants]
       
United States     113     115     114     342  



  Outcome Measures

1.  Primary:   Time to Treatment Failure (Measured in Days)   [ Time Frame: Measured during the 36-week treatment period ]

2.  Secondary:   Number of Episodes of Treatment Failure   [ Time Frame: Measured during the 36-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Time to First Asthma Exacerbation   [ Time Frame: Measured during the 36-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Number of Asthma Exacerbations   [ Time Frame: Measured during the 36-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Tests of Airway Caliber and Responsiveness (Forced Expiratory Volume in One Second (FEV1) Pre- and Post-bronchodilator Inhalation), Methacholine Provocative Concentration at 20% (PC20)   [ Time Frame: Measured during the 36-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Tests of Airway Inflammation (Exhaled Breath Condensate (EBC), Fractional Exhaled Nitric Oxide (FeNO), Sputum Eosinophils)   [ Time Frame: Measured during the 36-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Quality-of-life (AQLQ), Asthma Control Questionnaire (ACQ), and Number of Visit Days That ACQ is Less Than 1.25   [ Time Frame: Measured during the 36-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Total Amount of Oral Prednisone Required and Total Amount of Inhaled Steroids   [ Time Frame: Measured during the 36-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Adverse Events   [ Time Frame: Measured during the 36-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Symptom-based Adjustment Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Biomarker-based Adjustment Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Guideline-based Adjustment Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

Serious Adverse Events
    Symptom-based Adjustment     Biomarker-based Adjustment     Guideline-based Adjustment  
Total, serious adverse events        
# participants affected / at risk     6/113 (5.31%)     0/115 (0.00%)     1/114 (0.88%)  
General disorders        
hospitalizations for unrelated events      
# participants affected / at risk     6/113 (5.31%)     0/115 (0.00%)     1/114 (0.88%)  
# events     6     0     1  
Events were collected by systematic assessment




  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