Asthma Control in Elderly Patients With Montelukast
Overview[ - collapse ][ - ]
Purpose | 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 |
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Condition | Persistent Asthma Elderly |
Intervention | Drug: Combination of low ICS and montelukast Drug: Monotherapy of medium dose ICS |
Phase | Phase 4 |
Sponsor | Ajou University School of Medicine |
Responsible Party | Ajou University School of Medicine |
ClinicalTrials.gov Identifier | NCT01147510 |
First Received | June 18, 2010 |
Last Updated | November 10, 2013 |
Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | June 18, 2010 |
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Last Updated Date | November 10, 2013 |
Start Date | July 2010 |
Estimated Primary Completion Date | September 2012 |
Current Primary Outcome Measures | Rate of patients reaching "well controlled asthma status" [Time Frame: 12-weeks treatment] [Designated as safety issue: No]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) |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Asthma Control in Elderly Patients With Montelukast |
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Official Title | A Randomized Controlled Study of Montelukast Plus Low Dose Inhaled Budesonide Versus Medium Dose Inhaled Budesonide on Asthma Control in Elderly Patients |
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 clinical indicators and to compare treatment response according to leukotriene related genotypes in elderly patients with asthma |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: 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. Drug: 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 |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 140 |
Estimated Completion Date | September 2012 |
Estimated Primary Completion Date | September 2012 |
Eligibility Criteria | 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 |
Gender | Both |
Ages | 60 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01147510 |
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Other Study ID Numbers | AJIRB-GEN-CT4-10-095 |
Has Data Monitoring Committee | No |
Information Provided By | Ajou University School of Medicine |
Study Sponsor | Ajou University School of Medicine |
Collaborators | Hallym University Medical Center Wonju Severance Christian Hospital Korea University Guro Hospital Sanofi Pasteur MSD |
Investigators | Principal Investigator: Hae-Sim Park, MD, PhD Ajou University School of Medicine |
Verification Date | November 2013 |
Locations[ + expand ][ + ]
Ajou University Medical Center | Suwon, Korea, Republic of, 443-721 |
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