Asthma Clinical Research Network (ACRN) Trial - Macrolides in Asthma (MIA)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Asthma can be caused by a variety of factors, including tobacco smoke, allergens, and
      respiratory airway infections. Many people use inhaled corticosteroid medications to treat
      their symptoms. These medications, however, are not effective for everyone. Clarithromycin is
      an antibiotic that may effectively treat asthma in these individuals. This study will
      evaluate the effectiveness of clarithromycin at controlling asthma symptoms.
    

Detailed description: 
      Asthma prevalence has steadily increased in the United States since the early 1980s;
      currently, more than 20 million people are diagnosed with asthma. Individuals with this
      disease may experience periodic attacks of wheezing, shortness of breath, chest tightness,
      and coughing. While there are many known causes of asthma, including tobacco smoke and other
      allergens, the exact cause of some asthma cases remains unknown. Research has shown that in
      some individuals, respiratory airway infections may play a role in the onset and severity of
      the disease. Inhaled corticosteroids are commonly used to treat asthma; however, they do not
      effectively control symptoms for everyone. Clarithromycin, an antibiotic medication used to
      treat bacterial infections, may be an effective asthma treatment for individuals who do not
      respond well to inhaled corticosteroids. The purpose of this study is to evaluate the
      effectiveness of clarithromycin at reducing asthma symptoms.

      This study will begin with a 4-week run-in period to standardize participants' asthma
      medication usage. During this time, all participants will stop their current asthma
      medications and instead will receive inhaled fluticasone twice a day. Albuterol will be
      available as a rescue medication if necessary. Study visits will take place every 2 weeks.
      Blood and saliva samples will be obtained for laboratory tests and participants will complete
      standardized questionnaires to assess asthma symptoms and quality of life. Spirometry will be
      performed to measure lung function. Medication adherence will be monitored with a daily diary
      and an electronic pill counting device. At the end of Week 4, participants will be evaluated
      for study eligibility. If eligible, participants will undergo a bronchoscopy and a lung
      biopsy to test for Mycoplasma pneumoniae and Chlamydia pneumoniae, two bacteria that have
      been identified as possible factors in the development of asthma.

      The treatment phase of the study will last 16 weeks. Participants will be randomly assigned
      to receive either 500 mg of clarithromycin or placebo twice a day, plus inhaled fluticasone.
      At monthly study visits, spirometry and blood collection will be performed. Standardized
      questionnaires to assess asthma symptoms will be completed every 2 weeks. Medical adherence
      will continue to be monitored. At the end of Week 16, participants will stop receiving
      clarithromycin or placebo, but will continue to receive fluticasone. Asthma symptoms, rescue
      medication usage, quality of life, and lung capacity will be assessed; tissue samples will be
      examined for the presence of Mycoplasma pneumoniae and Chlamydia pneumoniae. An 8-week
      washout period will follow to observe any lingering medication effects and to monitor for
      safety. Monthly study visits during this period will include spirometry and blood collection.
    

Intervention name(s): clarithromycin; fluticasone propionate; placebo clarithromycin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): clarithromycin 500 mg twice daily (Biaxin); fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily); placebo clarithromycin twice daily
Other intervention name(s): Biaxin; Flovent®; placebo Biaxin
Intervention MeSH terms: Fluticasone; Xhance; Clarithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment