Bronchial AsthmaNCT01759472
Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Provocation Test
An observational study of Bronchial Asthma, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
To determine whether LTD4-BPT could be an effective indicator for predicting efficacy of anti-leukotriene therapy, allowing objective proofs for the use of LTRA among asthmatics in a specific sensitive to leukotriene population of asthma. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Bronchial Asthma
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Sep 2013
- Phase
- Observational
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Bronchial Asthma patients
Who may be able to join
- Aged 15-60 years, male or female.
- Mild to moderate persistent asthma.
- Mini AQLQ score ≤6 or ACQ score ≥1.
- Giving written informed consent.
Who cannot join
- Current smoker or quitted smoking ≤12 months.
- Significant allergen exposure.
- Respiratory tract infection within 2 weeks before or during the study.
- Cardiovascular disease.
- History of malignant disease within the preceding 5 years.
- And/or concomitant pulmonary disease.
- Pregnant or breast-feed period.
- Use of leukotrienes receptor antagonist within 5 days
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Disease, State Key Laboratory of Respiratory Disease
Guangzhou, Guangdong, 510120
Shi Xu, doctor, +8618026250151, shixu1003@163.com
About this study
Official title: Effect of Montelukast on Leukotriene Sensitive Asthma Detected by LTD4 Bronchial Provocation Test
To determine whether LTD4-BPT could be an effective indicator for predicting efficacy of anti-leukotriene therapy, allowing objective proofs for the use of LTRA among asthmatics in a specific sensitive to leukotriene population of asthma.
Hypothesis ：Monteluakst can better improve pre-challenge FEV1 from baseline in leukotriene-sensitive group than leukotriene-insensitive group.
- Conditions
- Bronchial Asthma
- Keywords
- leukotriene, leukotriene receptor antagonist
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| montelukast，vitamin C pill | leukotriene receptor antagonist:(montelukast)，montelukast (10 mg, once per night)，56 days vitamin C pill:100mg，once per night，56 days | |
| montelukast, vitamin C pill | montelukast:10 mg, once per night，56 days vitamin C pill:100mg，once per night，56 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
whether there was improvement in pre-challenge FEV1%
The primary outcome was a qualitative measure, with the results being expressed as either yes or no ('1' or '0' in Logistic model).A higher FEV1% is more suggestive of instability of asthma control.
Measured: from commencement of LTRA therapy to (7±2) days and (56±5) days
Secondary outcomes (1)
whether there was improvement in post- treatment FENO
In Logistic regression model, whether there was improvement shown in post-treatment FENO as compared with pre-treatment level was expressed as either 'yes' or 'no', with symbols of '1' or '0'. Thus the measure was qualitative one. FENO represented fractional exhaled nitric oxide above.
Measured: from commencement of LTRA therapy to (7±2) days and (56±5) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Shi, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759472
- Sponsor's protocol ID
- 2012BAI05B01
- Status last verified
- Jan 2013
- First submitted
- 28 Dec 2012
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Montelukast on Leukotriene Sensitive Asthma Detected by LTD4 Bronchial Provocation Test
- ClinicalTrials.gov ID
- NCT01759472
- Acronym / sponsor ID
- 2012BAI05B01
- Conditions
- Bronchial Asthma
- Keywords
- leukotriene, leukotriene receptor antagonist
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- First posted
- 3 Jan 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.
To determine whether LTD4-BPT could be an effective indicator for predicting efficacy of anti-leukotriene therapy, allowing objective proofs for the use of LTRA among asthmatics in a specific sensitive to leukotriene population of asthma.
Hypothesis ：Monteluakst can better improve pre-challenge FEV1 from baseline in leukotriene-sensitive group than leukotriene-insensitive group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| montelukast，vitamin C pill | – | –leukotriene receptor antagonist:(montelukast)，montelukast (10 mg, once per night)，56 days vitamin C pill:100mg，once per night，56 days |
| montelukast, vitamin C pill | – | –montelukast:10 mg, once per night，56 days vitamin C pill:100mg，once per night，56 days |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Bronchial Asthma patients
Key inclusion criteria (4 listed)
- Aged 15-60 years, male or female.
- Mild to moderate persistent asthma.
- Mini AQLQ score ≤6 or ACQ score ≥1.
- Giving written informed consent.
Key exclusion criteria (8 listed)
- Current smoker or quitted smoking ≤12 months.
- Significant allergen exposure.
- Respiratory tract infection within 2 weeks before or during the study.
- Cardiovascular disease.
- History of malignant disease within the preceding 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
whether there was improvement in pre-challenge FEV1%
Time frame: from commencement of LTRA therapy to (7±2) days and (56±5) days
The primary outcome was a qualitative measure, with the results being expressed as either yes or no ('1' or '0' in Logistic model).A higher FEV1% is more suggestive of instability of asthma control.
1 secondary outcome
whether there was improvement in post- treatment FENO
Time frame: from commencement of LTRA therapy to (7±2) days and (56±5) days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 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?
An observational study of Bronchial Asthma, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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 4 inclusion and 8 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 8 Jan 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Shi Xu, doctor (+8618026250151, shixu1003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
whether there was improvement in pre-challenge FEV1% (time frame: from commencement of LTRA therapy to (7±2) days and (56±5) days). 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 8 Jan 2013.