Effects of Montelukast on Airway Regulatory T Cells in Asthma
Overview[ - collapse ][ - ]
| Purpose | Montelukast is one of anti-inflammatory agents and a good controller for the patients with asthma. The hypothesis of the study is that the Montelukast will have airway anti-inflammatory effects and up-regulated regulatory T cells functions in asthma. |
|---|---|
| Condition | Asthma |
| Intervention | Drug: Montelukast |
| Phase | Phase 2/Phase 3 |
| Sponsor | Kurume University |
| Responsible Party | Kurume University |
| ClinicalTrials.gov Identifier | NCT01951898 |
| First Received | May 2, 2012 |
| Last Updated | September 24, 2013 |
| Last verified | September 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 2, 2012 |
|---|---|
| Last Updated Date | September 24, 2013 |
| Start Date | June 2012 |
| Estimated Primary Completion Date | May 2015 |
| Current Primary Outcome Measures | Montelukast will up-regulate airway regulatory T cell in the patients with asthma [Time Frame: 4wks of treatment period] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma [Time Frame: 4wks of treatment periods] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effects of Montelukast on Airway Regulatory T Cells in Asthma |
|---|---|
| Official Title | Effects of Montelukast on Airway Foxp3+ and CTLA4+CD25highCD4+ T Cells in Asthmatics |
| Brief Summary | Montelukast is one of anti-inflammatory agents and a good controller for the patients with asthma. The hypothesis of the study is that the Montelukast will have airway anti-inflammatory effects and up-regulated regulatory T cells functions in asthma. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2/Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Asthma |
| Intervention | Drug: Montelukast 10mg/day, once a daily after dinner, for 28dyas |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 15 |
| Estimated Completion Date | May 2015 |
| Estimated Primary Completion Date | December 2013 |
| Eligibility Criteria | Inclusion Criteria: - asthma - mild status - stable status - nonsmoker - Positive of airway hyperresponsiveness (Methacholine-PC20<16mg/mL) Exclusion Criteria: - taken other asthmatic medications such as oral, injective, and inhaled steroids, leukotriene antagonists, oral, inhaled, and transdermal beta-agonists, theophylline, anti-histamine agents, anti-IgE antibodies and long acting muscarinic receptor antagonists. - respiratory tract infections within 4wks - moderate to severe other organ disorders - active malignancies - past histories of side effects of leukotriene antagonists - psychological disorders - pregnancy or nursing |
| Gender | Both |
| Ages | 20 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Tomotaka Kawayama, MD +81-942-31-7560 kawayama_tomotaka@med.kurume-u.ac.jp |
| Location Countries | Japan |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01951898 |
|---|---|
| Other Study ID Numbers | KU-012012 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Kurume University |
| Study Sponsor | Kurume University |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | September 2013 |
Locations[ + expand ][ + ]
| Kurume University School of Medicine | Kurume, Japan Contact: Tomotaka Kawayama, MDPrincipal Investigator: Tomotaka Kawayama, MD Recruiting |
|---|