Asthma Control in Elderly Patients With Montelukast

Study Overview
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Brief Summary
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To compare the efficacy of combination therapy of montelukast plus low dose inhaled budesonide and single therapy of medium dose inhaled budesonide on asthma control such as inflammatory markers and clinical indicators and to compare treatment response according to leukotriene related genotypes in elderly patients with asthma

Official Title
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A Randomized Controlled Study of Montelukast Plus Low Dose Inhaled Budesonide Versus Medium Dose Inhaled Budesonide on Asthma Control in Elderly Patients

Conditions
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Persistent Asthma, Elderly

Intervention / Treatment
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* Drug: Combination of low ICS and montelukast
* Drug: Monotherapy of medium dose ICS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 60 - 75 years Patients diagnosed with asthma (NIH, 2007) over six months ago Patients maintaining monotherapy of low dose inhaled budesonide (pulmicort 400µg/day or ciclesonide 160 µg/day or fluticasone 250 µg/day) or combination of low dose inhaled budesonide and LABA (Seretide® 250 µg/day or Symbicort® 320 µg/day ) for over a month before the participation in this trial Patients not reaching 'well controlled asthma status' with four-week monotherapy of low dose inhaled budesonide (Pulmicort 400 µg/day) Patients who sufficiently listen to the purpose and content of this trial and the properties of investigational products and voluntarily agree with the participation to sign a written consent approved by IRB of Ajou University Medical Center before the participation in this trial Exclusion Criteria: Patients who show a symptom of an acute disease within 28 days before the beginning of this trial (administration of trial medication) Volunteers who are found to be unsuitable through screening tests Patients with history of hypersensitivity to montelukast or budesonide Patients participating in other clinical trial within three months before the beginning of this trial (administration of trial medication) current smokers having more than 10PYs of smoking history Patients needing administration of a medication which can affect asthma control such as systemic and immunoregulatory drugs (cyclosporin, omalizumab, etc.) due to a disease except asthma

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monotherapy of medium dose ICS<br> | Drug: Monotherapy of medium dose ICS<br>* Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m. and between 7 p.m. and 10 p.m. two times per day<br>|
| Experimental: Combination of low ICS and montelukast<br> | Drug: Combination of low ICS and montelukast<br>* Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m and take orally a tablet of Singulair® 10mg one time per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients reaching well controlled asthma status | Rate of patients reaching well controlled asthma status after 12-week treatment : evaluating comprehensively frequency of day symptoms and night symptoms, limit of activities and use of rescue medicine based on GINA guideline for asthma management (GINA 2006) and PEF or FEV1(% predicted) | 12-weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of inflammation | sputum eosinophils and neutrophils | baseline(W1), W5, W9, W13, W17 | 
| Time to first well-controlled week |  | during the 12 weeks of treatment | 
| Sub-group analysis of leukotrienes associated genotypes |  | visit 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma control in elderly patients, age 60-75