Asthma Control in Elderly Patients With Montelukast (ACEM)
This study is currently recruiting participants.
Verified February 2012 by Ajou University School of Medicine
Sponsor:
Ajou University School of Medicine
Collaborators:
Hallym University Medical Center
Yonsei University
Korea University Guro Hospital
Sanofi Pasteur MSD
Information provided by (Responsible Party):
Hae-Sim Park, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01147510
First received: June 18, 2010
Last updated: February 20, 2012
Last verified: February 2012
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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
| Condition | Intervention | Phase |
|---|---|---|
|
Persistent Asthma Elderly |
Drug: Combination of low ICS and montelukast Drug: Monotherapy of medium dose ICS |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Study of Montelukast Plus Low Dose Inhaled Budesonide Versus Medium Dose Inhaled Budesonide on Asthma Control in Elderly Patients |
Resource links provided by NLM:
Further study details as provided by Ajou University School of Medicine:
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)
Secondary Outcome Measures:
- Biomarkers of inflammation [ Time Frame: baseline(W1), W5, W9, W13, W17 ] [ Designated as safety issue: No ]sputum eosinophils and neutrophils
- Time to first well-controlled week [ Time Frame: during the 12 weeks of treatment ] [ Designated as safety issue: No ]
- Sub-group analysis of leukotrienes associated genotypes [ Time Frame: visit 1 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Monotherapy of medium dose ICS |
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
|
| Experimental: Combination of low ICS and montelukast |
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.
|
Eligibility| Ages Eligible for Study: | 60 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147510
Contacts
| Contact: Hae-Sim Park, MD, PhD | 82-31-219-5196 | hspark@ajou.ac.kr |
| Contact: Young- Min Ye, MD | 82-31-219-4262 | ye9007@ajou.ac.kr |
Locations
| Korea, Republic of | |
| Ajou University Medical Center | Recruiting |
| Suwon, Korea, Republic of, 443-721 | |
| Contact: YunKyoung Kim, CRA 82-31-219-4467 forsake326@ajou.ac.kr | |
| Contact: Young-Min Ye, MD ye9007@ajou.ac.kr | |
| Principal Investigator: Hae-Sim Park, MD, PhD | |
| Sub-Investigator: Young-Min Ye, MD | |
| Sub-Investigator: Seung-Hyun Kim, PhD | |
| Sub-Investigator: Hyun-Jeong Jin, MD | |
Sponsors and Collaborators
Ajou University School of Medicine
Hallym University Medical Center
Yonsei University
Korea University Guro Hospital
Sanofi Pasteur MSD
Investigators
| Principal Investigator: | Hae-Sim Park, MD, PhD | Ajou University School of Medicine |
More Information
No publications provided
| Responsible Party: | Hae-Sim Park, Professor, Department of allergy part, Ajou University School of Medicine, Ajou University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01147510 History of Changes |
| Other Study ID Numbers: | AJIRB-GEN-CT4-10-095, A070001 |
| Study First Received: | June 18, 2010 |
| Last Updated: | February 20, 2012 |
| Health Authority: | Korea: Food and Drug Administration Korea: Ministry for Health, Welfare and Family Affairs |
Keywords provided by Ajou University School of Medicine:
|
asthma control in elderly patients age 60-75 |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Montelukast Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013