Mild Persistent AsthmaNCT01581710
Response of FeNO, Small Airway Dysfunction and Lung Heterogeneity to 2-week Montelukast Treatment in Asthmatic Children.
A study of Mild Persistent Asthma, run by CHA University.
Trial summary
This study aims to identify markers to prove rapid improvement of lung function, airway inflammation and bronchodilator response after 2-week LTRA administration. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Mild Persistent Asthma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children diagnosed with mild persistent asthma patients based on the GINA guidelines
- children old enough to cooperate in performing pulmonary function testing
- legal guardians who sufficiently listen to the purpose and voluntarily agree with the participation to sign a written consent approved by IRB
- children with no respiratory symptoms 4 weeks prior to the beginning of the study
- children without chronic respiratory symptoms.
Who cannot join
- presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy.
- use of systemic corticosteroids in past 4 weeks.
- admission or visit of the emergency department in past 4 weeks.
About this study
Official title: A Double-blind, Randomized, Cross-over Design Study to Compare the Lung Function Measure of Montelukast Versus Placebo in Children With Mild Persistent Asthma
This study aims to identify markers to prove rapid improvement of lung function, airway inflammation and bronchodilator response after 2-week LTRA administration.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, cross-over study with a washout period of at least one week between each study period.
After an initial screening visit, subjects entered a screening period of one to two weeks to ensure clinical stability without medication, which means absence of daily asthma symptoms. Eligible subjects were randomized into either the treatment portion of the trial, in which subjects received montelukast (4 mg or 5 mg) or matching placebo monotherapy in a randomized manner. During each treatment period, which lasted 2 weeks, the study medication was administered between 8:00 and 9:00 A.M. Short acting bronchodilator (for severe symptoms) was permitted during the study period but was withheld 24 hours prior to bronchodilator challenge test.
Inclusion criteria will be mild persistent asthma children old enough to cooperate on performing pulmonary function testing, children with no respiratory symptoms 4 weeks prior to the beginning of the study. Exclusion criteria will be the following: respiratory symptoms including cough, wheezing, dyspnea, or shortness of breath, presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy, use of systemic corticosteroids, or admission or visit of the emergency department during the previous 4 weeks.
- Conditions
- Mild Persistent Asthma
- Being tested
- Montelukast to placebo, Placebo to montelukast
- Keywords
- Leukotriene Antagonists, Bronchodilator response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast to placeboDrug
Also called SINGULAIR 4mg or 5mg
Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks
Placebo to montelukastDrug
Also called SINGULAIR 4mg or 5mg matching placebo
Subjects will receive matching placebo. Each treatment period consists of 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| montelukast to placebo | Active comparator | 14 days Receives: Drug: Montelukast to placebo |
| Washout | No intervention | 14 days |
| Placebo to montelukast | Active comparator | 14 days Receives: Drug: Placebo to montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)
Pre Rrs 5: Resistance at 5Hz before the administration of bronchodilator
Measured: up to 2 weeks
Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5)
Pre Xrs 5: Reactance at 5Hz before the administration of bronchodilator
Measured: up to 2 weeks
Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator
Pre Rrs10: Resistance at 10Hz before the administration of bronchodilator
Measured: up to 2 weeks
Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10)
Pre Xrs 10: Reactance at 10Hz before the administration of bronchodilator
Measured: up to 2 weeks
Baseline Lung Function of FEV1 Before the Bronchodilator
baseline lung function in forced expiratory volume in 1 second before the administration of bronchodilator
Measured: up to 2 weeks
Baseline Lung Function of FEV1/FVC Before the Bronchodilator
baseline lung function in forced expiratory volume in 1 second/forced vital capacity before the administration of bronchodilator
Measured: up to 2 weeks
Baseline Lung Function in MMEF
Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator
Measured: up to 2 weeks
Secondary outcomes (1)
Relative Change (%) of FEV1 After the Bronchodilator
Relative change in percentage of FEV1 after the bronchodilator, 2weeks after placebo and montelukast administration Relative change (%) in FEV1 = (((FEV1 post-bronchodilator)-(FEV1 pre-bronchodilator))/baseline FEV1) x 100
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Persistent 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Man Yong Han, CHA University
- Investigators
- Man Yong Han, Principal investigator, specify Unaffiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581710
- Sponsor's protocol ID
- CHA-121
- Status last verified
- Mar 2018
- First submitted
- 13 Apr 2012
- Last updated
- 12 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Cross-over Design Study to Compare the Lung Function Measure of Montelukast Versus Placebo in Children With Mild Persistent Asthma
- ClinicalTrials.gov ID
- NCT01581710
- Acronym / sponsor ID
- CHA-121
- Conditions
- Mild Persistent Asthma
- Keywords
- Leukotriene Antagonists, Bronchodilator response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Posted 12 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to identify markers to prove rapid improvement of lung function, airway inflammation and bronchodilator response after 2-week LTRA administration.
Detailed description
This study is a randomized, double-blind, placebo-controlled, cross-over study with a washout period of at least one week between each study period.
After an initial screening visit, subjects entered a screening period of one to two weeks to ensure clinical stability without medication, which means absence of daily asthma symptoms. Eligible subjects were randomized into either the treatment portion of the trial, in which subjects received montelukast (4 mg or 5 mg) or matching placebo monotherapy in a randomized manner. During each treatment period, which lasted 2 weeks, the study medication was administered between 8:00 and 9:00 A.M. Short acting bronchodilator (for severe symptoms) was permitted during the study period but was withheld 24 hours prior to bronchodilator challenge test.
Inclusion criteria will be mild persistent asthma children old enough to cooperate on performing pulmonary function testing, children with no respiratory symptoms 4 weeks prior to the beginning of the study. Exclusion criteria will be the following: respiratory symptoms including cough, wheezing, dyspnea, or shortness of breath, presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy, use of systemic corticosteroids, or admission or visit of the emergency department during the previous 4 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| montelukast to placebo | Active comparator | Drug: Montelukast to placebo14 days |
| Washout | No intervention | –14 days |
| Placebo to montelukast | Active comparator | Drug: Placebo to montelukast14 days |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- children diagnosed with mild persistent asthma patients based on the GINA guidelines
- children old enough to cooperate in performing pulmonary function testing
- legal guardians who sufficiently listen to the purpose and voluntarily agree with the participation to sign a written consent approved by IRB
- children with no respiratory symptoms 4 weeks prior to the beginning of the study
- children without chronic respiratory symptoms.
Key exclusion criteria (3 listed)
- presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy.
- use of systemic corticosteroids in past 4 weeks.
- admission or visit of the emergency department in past 4 weeks.
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 |
|---|---|---|
| Montelukast to placeboAlso: SINGULAIR 4mg or 5mgSubjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks | Drug | montelukast to placebo |
| Placebo to montelukastAlso: SINGULAIR 4mg or 5mg matching placeboSubjects will receive matching placebo. Each treatment period consists of 2 weeks | Drug | Placebo to montelukast |
Primary outcome
Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)
Time frame: up to 2 weeks
Pre Rrs 5: Resistance at 5Hz before the administration of bronchodilator
Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5)
Time frame: up to 2 weeks
Pre Xrs 5: Reactance at 5Hz before the administration of bronchodilator
Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator
Time frame: up to 2 weeks
Pre Rrs10: Resistance at 10Hz before the administration of bronchodilator
Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10)
Time frame: up to 2 weeks
Pre Xrs 10: Reactance at 10Hz before the administration of bronchodilator
Baseline Lung Function of FEV1 Before the Bronchodilator
Time frame: up to 2 weeks
baseline lung function in forced expiratory volume in 1 second before the administration of bronchodilator
Baseline Lung Function of FEV1/FVC Before the Bronchodilator
Time frame: up to 2 weeks
baseline lung function in forced expiratory volume in 1 second/forced vital capacity before the administration of bronchodilator
Baseline Lung Function in MMEF
Time frame: up to 2 weeks
Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator
1 secondary outcome
Relative Change (%) of FEV1 After the Bronchodilator
Time frame: up to 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Man Yong Han principal investigator
specify Unaffiliated
Questions about this trial
What is this clinical trial studying?
A study of Mild Persistent Asthma, run by CHA University.
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 3 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: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 12 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5) (time frame: up to 2 weeks). The study lists 7 primary outcomes in all. 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 12 Apr 2018.