AsthmaPhase 2/3NCT01951898
Effects of Montelukast on Airway Regulatory T Cells in Asthma
A Phase 2/3 study testing Montelukast in people with Asthma, run by Kurume University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Montelukast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2012to May 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- asthma
- mild status
- stable status
- nonsmoker
- Positive of airway hyperresponsiveness (Methacholine-PC20<16mg/mL)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kurume University School of Medicine
Kurume
Tomotaka Kawayama, MD
Tomotaka Kawayama, MD
About this study
Official title: Effects of Montelukast on Airway Foxp3+ and CTLA4+CD25highCD4+ T Cells in Asthmatics
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.
- Conditions
- Asthma
- Being tested
- Montelukast
- Keywords
- asthma, regulatory T cells, leukotriene antagonist
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
10mg/day, once a daily after dinner, for 28dyas
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Active comparator | Not described Receives: Drug: Montelukast |
| Vitamin B6 | Sham comparator | Not described Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montelukast will up-regulate airway regulatory T cell in the patients with asthma
Measured: 4wks of treatment period
Secondary outcomes (1)
Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma
Measured: 4wks of treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2013 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kurume University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomotaka Kawayama, Kurume University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951898
- Sponsor's protocol ID
- KU-012012
- Status last verified
- Sep 2013
- First submitted
- 2 May 2012
- Last updated
- 27 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Montelukast on Airway Foxp3+ and CTLA4+CD25highCD4+ T Cells in Asthmatics
- ClinicalTrials.gov ID
- NCT01951898
- Acronym / sponsor ID
- KU-012012
- Conditions
- Asthma
- Keywords
- asthma, regulatory T cells, leukotriene antagonist
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Kurume UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 27 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Active comparator | Drug: Montelukast |
| Vitamin B6 | Sham comparator | Drug: Montelukast |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- asthma
- mild status
- stable status
- nonsmoker
- Positive of airway hyperresponsiveness (Methacholine-PC20<16mg/mL)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montelukast10mg/day, once a daily after dinner, for 28dyas | Drug | Montelukast, Vitamin B6 |
Primary outcome
Montelukast will up-regulate airway regulatory T cell in the patients with asthma
Time frame: 4wks of treatment period
1 secondary outcome
Montelukast will improve airway inflammation, lung function and hyperresponsiveness in the patients with asthma
Time frame: 4wks of treatment periods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Montelukast in people with Asthma, run by Kurume University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomotaka Kawayama, MD (+81-942-31-7560, kawayama_tomotaka@med.kurume-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montelukast will up-regulate airway regulatory T cell in the patients with asthma (time frame: 4wks of treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2013.