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Asthma Clinical Research Network (ACRN) Trial - Macrolides in Asthma (MIA)

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:
NCT00318708
First received: April 25, 2006
Last updated: December 28, 2012
Last verified: December 2012
History of Changes
Results First Received: April 27, 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: Drug: clarithromycin
Drug: fluticasone propionate
Drug: placebo clarithromycin

  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
Clarithromycin + Fluticasone clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Placebo + Fluticasone placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)

Participant Flow:   Overall Study
    Clarithromycin + Fluticasone     Placebo + Fluticasone  
STARTED     47     45  
8-week Milestone     42     42  
COMPLETED     39     40  
NOT COMPLETED     8     5  



  Baseline Characteristics
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Reporting Groups
  Description
Clarithromycin + Fluticasone Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
Placebo + Fluticasone Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
Total Total of all reporting groups

Baseline Measures
    Clarithromycin + Fluticasone     Placebo + Fluticasone     Total  
Number of Participants  
[units: participants]
 		  47     45     92  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     47     45     92  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  41.3  ± 12.5     37.5  ± 10.5     39.5  ± 11.5  
Gender  
[units: participants]
 		     
Female     27     25     52  
Male     20     20     40  
Region of Enrollment  
[units: participants]
 		     
United States     47     45     92  



  Outcome Measures

1.  Primary:   Juniper Asthma Control Questionnaire (ACQ) Results   [ Time Frame: Measured every four weeks during the 16-week treatment period, with the change (week 16 minus baseline) as the primary outcome ]
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2.  Secondary:   Asthma Symptoms   [ Time Frame: Measured during the 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Asthma Rescue Medication Use   [ Time Frame: Measured during the 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   AM and PM Peak Expiratory Flow (PEF)   [ Time Frame: Measured during the 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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

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

7.  Secondary:   Methacholine Provocative Concentration (PC20)   [ Time Frame: Measured during the 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Exhaled Nitric Oxide (eNO)   [ Time Frame: Measured during the 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Blood Cell Counts   [ Time Frame: Measured during the 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

10.  Secondary:   AM Cortisol   [ Time Frame: Measured during the 16-week treatment period ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

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


  Serious Adverse Events
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  Other Adverse Events
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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.


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
Participants underwent endobronchial biopsy for characterization of lower airway status for M pneumoniae or C pneumoniae. The target sample size was 72 positives and 72 negatives. Only 80 and 12 were recruited, respectively.  


Results Point of Contact:  
Name/Title: Vernon M. Chinchilli, PhD
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: NCT00318708     History of Changes
Other Study ID Numbers: 377, U10HL074231, 5U10 HL074231, 7U10 HL074206, 5U10 HL074208, 5U10 HL074073, 5U10 HL074227, 5U10 HL074225, 5U10 HL074204, 5U10 HL074218, 5U10 HL074212
Study First Received: April 25, 2006
Results First Received: April 27, 2012
Last Updated: December 28, 2012
Health Authority: United States: Food and Drug Administration