Status:
COMPLETED
Asthma Control in Elderly Patients With Montelukast
Lead Sponsor:
Ajou University School of Medicine
Collaborating Sponsors:
Hallym University Medical Center
Wonju Severance Christian Hospital
Conditions:
Persistent Asthma
Elderly
Eligibility:
All Genders
60-75 years
Phase:
PHASE4
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01147510
Start Date
July 1 2010
End Date
September 1 2012
Last Update
November 13 2013
Active Locations (1)
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1
Ajou University Medical Center
Suwon, South Korea, 443-721