Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
140 participants
INTERVENTIONAL
2010-07-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monotherapy of medium dose ICS
Monotherapy of medium dose ICS
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
Combination of low ICS and montelukast
Combination of low ICS and montelukast
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.
Interventions
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Combination of low ICS and montelukast
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.
Monotherapy of medium dose ICS
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
75 Years
ALL
No
Sponsors
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Hallym University Medical Center
OTHER
Wonju Severance Christian Hospital
OTHER
Korea University Guro Hospital
OTHER
MCM Vaccines B.V.
INDUSTRY
Ajou University School of Medicine
OTHER
Responsible Party
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Hae-Sim Park
Professor, Department of allergy part, Ajou University School of Medicine
Principal Investigators
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Hae-Sim Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ajou University School of Medicine
Locations
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Ajou University Medical Center
Suwon, , South Korea
Countries
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Other Identifiers
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A070001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AJIRB-GEN-CT4-10-095
Identifier Type: -
Identifier Source: org_study_id