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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00318708
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : February 4, 2013
Last Update Posted : March 23, 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: clarithromycin
Drug: fluticasone propionate
Drug: placebo clarithromycin
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clarithromycin + Fluticasone Placebo + Fluticasone
Hide Arm/Group Description clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily) placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Period Title: Overall Study
Started 47 45
8-week Milestone 42 42
Completed 39 40
Not Completed 8 5
Arm/Group Title Clarithromycin + Fluticasone Placebo + Fluticasone Total
Hide Arm/Group Description Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid) Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid) Total of all reporting groups
Overall Number of Baseline Participants 47 45 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 45 participants 92 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
47
 100.0%
45
 100.0%
92
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 45 participants 92 participants
41.3  (12.5) 37.5  (10.5) 39.5  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 45 participants 92 participants
Female
27
  57.4%
25
  55.6%
52
  56.5%
Male
20
  42.6%
20
  44.4%
40
  43.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 45 participants 92 participants
47 45 92
1.Primary Outcome
Title Juniper Asthma Control Questionnaire (ACQ) Results
Hide Description The Juniper asthma control questionnaire (ACQ) consists of six questions answered by the asthma patient with respect to symptoms, rescue medication use, and night-time awakenings due to asthma. A seventh item in the ACQ is the percent predicted FEV1. Each of the seven items is scored from from 0 (best) to 6 (worst), and then the seven items are averaged to yield a number from 0 (best) to 6 (worst). Asthma patients needed to display an ACQ greater than or equal to 1.25 in order to be eligible for randomization. A reduction of 0.5 units or more in the ACQ over the 16 weeks of treatment is considered to be clinically significant.
Time Frame Measured every four weeks during the 16-week treatment period, with the change (week 16 minus baseline) as the primary outcome
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).
Arm/Group Title Clarithromycin + Fluticasone Placebo + Fluticasone
Hide Arm/Group Description:
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Overall Number of Participants Analyzed 39 39
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.15  (0.14) -0.38  (0.14)
2.Secondary Outcome
Title Asthma Rescue Medication Use
Hide Description number of rescue puffs per day
Time Frame the week-16 average minus the baseline-week average
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).
Arm/Group Title Clarithromycin + Fluticasone Placebo + Fluticasone
Hide Arm/Group Description:

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

clarithromycin: clarithromycin 500 mg twice daily (Biaxin)

fluticasone propionate: fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)

placebo clarithromycin twice daily + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)

fluticasone propionate: fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)

placebo clarithromycin: placebo clarithromycin twice daily

Overall Number of Participants Analyzed 39 39
Least Squares Mean (Standard Error)
Unit of Measure: rescue puffs per day
-0.71  (0.23) -0.14  (0.24)
3.Secondary Outcome
Title AM Peak Expiratory Flow (PEF)
Hide Description daily AM peak expiratory flow (PEF) measured in liters per minute
Time Frame the week-16 average minus the baseline-week average
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).
Arm/Group Title Clarithromycin + Fluticasone Placebo + Fluticasone
Hide Arm/Group Description:
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Overall Number of Participants Analyzed 39 39
Least Squares Mean (Standard Error)
Unit of Measure: liters per minute
8.31  (4.55) 11.69  (4.48)
4.Secondary Outcome
Title Forced Expiratory Volume in One Second (FEV1)
Hide Description Forced expiratory volume in one second (FEV1) from spirometry
Time Frame the week-16 value minus the baseline-value
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).
Arm/Group Title Clarithromycin + Fluticasone Placebo + Fluticasone
Hide Arm/Group Description:
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Overall Number of Participants Analyzed 39 39
Least Squares Mean (Standard Error)
Unit of Measure: Liters
-0.08  (0.05) -0.06  (0.06)
5.Secondary Outcome
Title Methacholine Provocative Concentration (PC20)
Hide Description Logarithm-base 2 transformed Methacholine provocative concentration (PC20) based on FEV1
Time Frame the week-16 value minus the baseline-value
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).
Arm/Group Title Clarithromycin + Fluticasone Placebo + Fluticasone
Hide Arm/Group Description:
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Overall Number of Participants Analyzed 39 39
Least Squares Mean (Standard Error)
Unit of Measure: logarithm-base 2 of mg/mL
1.39  (0.30) 0.41  (0.30)
6.Secondary Outcome
Title Exhaled Nitric Oxide (eNO)
Hide Description Exhaled nitric oxide (eNO) measured in parts per billion
Time Frame the week-16 value minus the baseline-value
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).
Arm/Group Title Clarithromycin + Fluticasone Placebo + Fluticasone
Hide Arm/Group Description:
clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Overall Number of Participants Analyzed 39 39
Least Squares Mean (Standard Error)
Unit of Measure: parts per billion
-0.33  (3.16) 3.04  (3.26)
7.Secondary Outcome
Title Asthma Quality of Life Questionnaire (AQLQ)
Hide Description The Asthma Quality of Life Questionnaire (AQLQ) consists of 32 questions, with each question ranging from 1 (worst) to 7 (best). The 32 questions are averaged to yield an overall score, which is reported here. Therefore, a positive change between the 16-week score and the baseline score represents improvement.
Time Frame the week-16 value minus the baseline-value
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for the analysis was determined as the number who completed the full 16 weeks (value at 16 weeks minus value at baseline).
Arm/Group Title Clarithromycin + Fluticasone Placebo + Fluticasone
Hide Arm/Group Description:
Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
Overall Number of Participants Analyzed 39 39
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale (1 through 7)
0.41  (0.16) 0.59  (0.15)
Time Frame 6 months
Adverse Event Reporting Description does not differ from clinicaltrials.gov definitions
 
Arm/Group Title Clarithromycin + Fluticasone Placebo + Fluticasone
Hide Arm/Group Description Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid) Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
All-Cause Mortality
Clarithromycin + Fluticasone Placebo + Fluticasone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clarithromycin + Fluticasone Placebo + Fluticasone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/47 (0.00%)      0/45 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clarithromycin + Fluticasone Placebo + Fluticasone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/47 (19.15%)      7/45 (15.56%)    
Gastrointestinal disorders     
gastrointestinal events *  7/47 (14.89%)  9 3/45 (6.67%)  5
Respiratory, thoracic and mediastinal disorders     
respiratory infections *  5/47 (10.64%)  5 5/45 (11.11%)  5
*
Indicates events were collected by non-systematic assessment
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.
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 Hershey College of Medicine
Phone: 717-531-4262
Responsible Party: Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00318708     History of Changes
Other Study ID Numbers: 377
U10HL074231 ( U.S. NIH Grant/Contract )
5U10HL074231 ( U.S. NIH Grant/Contract )
7U10HL074206 ( U.S. NIH Grant/Contract )
5U10HL074208 ( U.S. NIH Grant/Contract )
5U10HL074073 ( U.S. NIH Grant/Contract )
5U10HL074227 ( U.S. NIH Grant/Contract )
5U10HL074225 ( U.S. NIH Grant/Contract )
5U10HL074204 ( U.S. NIH Grant/Contract )
5U10HL074218 ( U.S. NIH Grant/Contract )
5U10HL074212 ( U.S. NIH Grant/Contract )
First Submitted: April 25, 2006
First Posted: April 27, 2006
Results First Submitted: April 27, 2012
Results First Posted: February 4, 2013
Last Update Posted: March 23, 2018