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AsthmaPhase 3MIANCT00318708

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

A Phase 3 study testing clarithromycin and fluticasone propionate in people with Asthma, run by Milton S. Hershey Medical Center at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Asthma
What is being tested?
clarithromycin and fluticasone propionate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
10 sitesUnited States
Study dates
Jun 2006to Apr 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • History of physician-diagnosed asthma
  • Methacholine PC20 less than or equal to 16 mg/ml and/or FEV1 improvement greater than or equal to 12% in response to 180 mcg albuterol
  • Stable asthma for at least 6 weeks prior to study entry
  • FEV1 greater than or equal to 60% of predicted result following 180 mcg albuterol
  • Juniper ACQ score greater than or equal to 1.5 (optimal ACQ score cut-off point for asthma that is "not well-controlled" by NIH/Global Initiative for Asthma [GINA] guidelines)
  • Nonsmoker (less than 10 pack-per-year lifetime smoking history and no smoking in the year prior to study entry)
Show all 13Show fewer
  • Able to perform spirometry, as per American Thoracic Society criteria
  • 75% adherence with diary cards, fluticasone (monitored with Doser), and placebo pill trial (monitored electronically with Electronic Drug Exposure Monitor [eDEM] pill dose counter) for the final 2 weeks of the four-week run-in period
  • At Visit 1, in steroid-naïve participants, no significant adrenal suppression, defined as a plasma cortisol concentration less than 5 mcg/dL. If adrenal suppression occurs, a 250 mcg corticotropin (ACTH) stimulation test will be performed. Plasma cortisol levels will be collected at baseline, and 30 and 60 minutes after the ACTH stimulation test. Participants must have a cortisol concentration greater than 20 mcg/dL on at least one of the post-ACTH time points
  • Absence of bronchoscopy-induced exacerbation; if bronchoscopy-induced exacerbation has occurred, prednisone therapy must have stopped at least 6 weeks prior to study entry
  • Absence of respiratory tract infection; if infection has occurred, infection-related symptoms must have stopped at least 6 weeks prior to study entry
  • Has experienced no more than two exacerbations or respiratory tract infections prior to study entry
  • If female and able to conceive, willing to utilize two medically acceptable forms of contraception (one non-barrier method with single barrier method OR double barrier method)

Who cannot join

  • Presence of lung disease other than asthma
  • Presence of vocal cord dysfunction, due to potential confounding of ACQ score
  • Significant medical illness other than asthma
  • History of atrial or ventricular tachyarrhythmia
  • Use of any medication that has a significant interaction with clarithromycin, including herbal or alternative therapies
  • Asthma exacerbation within 6 weeks of the screening visit or during the run-in period prior to bronchoscopy
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  • Use of systemic steroids or change in dose of controller therapy within 6 weeks of the screening visit
  • Inability, in the opinion of the study investigator, to coordinate use of dry powder or metered-dose inhaler or to comply with medication regimens
  • Inability or unwillingness to perform required study procedures
  • Prolonged heart rate corrected QT-interval (greater than 450 msec in women and greater than 430 msec in men) on echocardiogram (ECG) at study entry
  • Low potassium or magnesium levels (based on local Asthma Clinical Research Network laboratory definitions)
  • Abnormal elevation of liver function tests (AST, ALT, total bilirubin, or alkaline phosphatase)
  • Abnormal prothrombin time (PT) or partial thromboplastin time (PTT) results
  • Reduced creatinine clearance
  • Contraindication to bronchoscopy, as determined by medical history or physical examination
  • Regular consumption of grapefruit or grapefruit juice
  • Pregnant or breastfeeding

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • National Jewish Medical and Research Center

    Denver, Colorado, 80206

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • University of Wisconsin, Madison

    Madison, Wisconsin, 53706

  • Columbia University Medical Center

    New York, New York, 10032

  • University of California, San Diego

    San Diego, California, 92093

  • University of California, San Francisco

    San Francisco, California, 94143

  • Washington University, St. Louis

    St Louis, Missouri, 63130

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the 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.

Conditions
Asthma
Being tested
clarithromycin, fluticasone propionate, placebo clarithromycin
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clarithromycinDrug

    Also called Biaxin

    clarithromycin 500 mg twice daily (Biaxin)

  • fluticasone propionateDrug

    Also called Flovent®

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

  • placebo clarithromycinDrug

    Also called placebo Biaxin

    placebo clarithromycin twice daily

Study groups in NCT00318708
Study groupRoleWhat they receive
clarithromycin + fluticasoneExperimentalclarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Receives: Drug: clarithromycin; Drug: fluticasone propionate
placebo + fluticasoneActive comparatorplacebo clarithromycin twice daily + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
Receives: Drug: fluticasone propionate; Drug: placebo clarithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Juniper Asthma Control Questionnaire (ACQ) Results

    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.

    Measured: Measured every four weeks during the 16-week treatment period, with the change (week 16 minus baseline) as the primary outcome

Secondary outcomes (6)

  1. Asthma Rescue Medication Use

    number of rescue puffs per day

    Measured: the week-16 average minus the baseline-week average

  2. AM Peak Expiratory Flow (PEF)

    daily AM peak expiratory flow (PEF) measured in liters per minute

    Measured: the week-16 average minus the baseline-week average

  3. Forced Expiratory Volume in One Second (FEV1)

    Forced expiratory volume in one second (FEV1) from spirometry

    Measured: the week-16 value minus the baseline-value

  4. Methacholine Provocative Concentration (PC20)

    Logarithm-base 2 transformed Methacholine provocative concentration (PC20) based on FEV1

    Measured: the week-16 value minus the baseline-value

  5. Exhaled Nitric Oxide (eNO)

    Exhaled nitric oxide (eNO) measured in parts per billion

    Measured: the week-16 value minus the baseline-value

  6. Asthma Quality of Life Questionnaire (AQLQ)

    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.

    Measured: the week-16 value minus the baseline-value

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionApr 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00318708
Sponsor's protocol ID
377
Other IDs
U10HL074231, 5U10HL074231, 7U10HL074206, 5U10HL074208, 5U10HL074073, 5U10HL074227, 5U10HL074225, 5U10HL074204
Acronym
MIA
Status last verified
Mar 2018
First submitted
25 Apr 2006
Last updated
23 Mar 2018
Data monitoring committee
Yes

Publications

  • Sutherland ER, King TS, Icitovic N, Ameredes BT, Bleecker E, Boushey HA, Calhoun WJ, Castro M, Cherniack RM, Chinchilli VM, Craig TJ, Denlinger L, DiMango EA, Fahy JV, Israel E, Jarjour N, Kraft M, Lazarus SC, Lemanske RF Jr, Peters SP, Ramsdell J, Sorkness CA, Szefler SJ, Walter MJ, Wasserman SI, Wechsler ME, Chu HW, Martin RJ; National Heart, Lung and Blood Institute's Asthma Clinical Research Network. A trial of clarithromycin for the treatment of suboptimally controlled asthma. J Allergy Clin Immunol. 2010 Oct;126(4):747-53. doi: 10.1016/j.jaci.2010.07.024.

    PubMed 20920764

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing clarithromycin and fluticasone propionate in people with Asthma, run by Milton S. Hershey Medical Center at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00318708, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.

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