Bronchial AsthmaPhase 4NCT01618929
Effects of Montelukast in Asthmatic Children With and Without Food Allergy
A Phase 4 study testing Montelukast in people with Bronchial Asthma and Food Allergy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
To search the effects of montelukast on the airway inflammation including FEV1%, FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge tests, the leukotriene levels in the exhaled breath condensate in asthmatic children with and without food allergy aged 6-18 years old. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Bronchial Asthma, Food Allergy, Children
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2013to May 2016
- Phase
- Phase 4
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Physician diagnosed asthma (12% reversibility on spirometry test or positive response to provocholine® provocation test).
- Mild to moderate asthmatic children. Asthmatic children with pre-budesonide FEV1/FVC ≥ 80% will be included.
- At least one food allergy confirmed by specific IgE level or skin prick test positivity and a relevant clinical history or open challenge test with food.
- Aged between 6-18 years old.
- Acceptance of involvement in the study and signed informed consent (Both patients and one of the parents)
Who cannot join
- Who does not sign the informed consent.
- Severe asthmatic children
- Any lung disease except asthma (i.e. cystic fibrosis, bronchiectasia, primary ciliary dyskinesia).
- Any systemic disease except allergic rhinitis and atopic dermatitis
- Follow-up in intensive care unit or intubation for asthma exacerbation within one year.
- Attendance to emergency room or hospital admission within 3 months for asthma exacerbation
Show all 14Show fewer
- Systemic steroid usage within 3 months
- Upper airway infection within one month.
- Psychiatric or psychosocial problems
- Poor compliance to asthma treatment protocol
- Any condition contra-indicated for montelukast usage
- To be aware of the name of the drug either patient or study staff during the study period.
- Worsening of the clinical condition during run-in period.
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Effects of Montelukast Treatment on Allergic Inflammation in Children With and Without Food Allergy, Single Centered, Randomised, Double Blind, Placebo Controlled Parallel Group Cross-over Study
- To search the effects of montelukast on the airway inflammation including FEV1%, FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge tests, the leukotriene levels in the exhaled breath condensate in asthmatic children with and without food allergy aged 6-18 years old.
- To define the patient groups with good response to montelukast and to define the parameters which predict the good response.
Read the detailed description
The aim of this analysis is to determine whether the children with food allergy may have more eosinophilic inflammation in the airways (as measured by FENO) or they may have Cysteinyl leukotrienes based inflammation in the airways that will be shown by high levels of Cys LT and low levels of lipoxin in the exhaled breath condensate. Our suggestion is that a special pattern of inflammation may be seen in asthmatics with food allergy because of their strong atopic march history and then we aimed to test if montelukast is more effective in children when the ratio of Cysteinyl LT inflammation is high relative to FENO (eosinophilic inflammation). This study will be the first to evaluate the effect of montelukast regarding the synthesis of Cys leukotrienes, lipoxin and FENO that will be measured from exhaled breath condensate, which is the mirror of the local inflammation in the airways in asthmatic children with atopy (food allergy). As we mentioned above another factor that we are planning to analyze is the ratio of Cys leukotriene to lipoxin, which is the natural antagonist of LT. This study will determine the ratio of Cyst LT to lipoxin and Cyst LT to FENO in the exhaled breath condensate and then there will be an analysis to see the correlation of these inflammatory markers with montelukast related changes on FEV1%, FEV1%/FVC.
- Conditions
- Bronchial Asthma, Food Allergy, Children
- Being tested
- Montelukast
- Keywords
- Food allergy, Asthma, Children, Montelukast, Inflammation
- Medical subject headings
- Asthma, Food Hypersensitivity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Singulair 5 mg tablets, Singulair 10 mg tablets, Placebo 5 mg tablets, Placebo 10 mg tablets
Placebo and montelukast (5 mg for 6-14 years of age and 10 mg for 14-18 years of age once a day) will be given following one another in 4 weeks periods including a 2 weeks wash-out period in between in a cross over design.
| Study group | Role | What they receive |
|---|---|---|
| asthma with food allergy | Active comparator | The study will be performed in 2 groups of patients (Patients with and without food allergy) parallel to each other at the same time and within each group the patients will take montelukast and placebo (one after another in a double-blind design). Receives: Drug: Montelukast |
| asthma without food allergy | Active comparator | The study will be performed in 2 groups of patients (Patients with and without food allergy) parallel to each other at the same time and within each group the patients will take montelukast and placebo (one after another in a double-blind design) Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in FEV1% between two arms.
The asthmatic children with and without food allergy will be given placebo and montelukast following one another in a cross over design. The study will be performed in 2 groups of patients (Patients with and without food allergy) parallel to each other at the same time and within each group the patients will take montelukast and placebo. A total of 5 spirometry tests (At the beginning and end of run-in periods, at the beginning of cross-over period, at the end of wash-out period and at the end of the study) will be done and forced expiratory volume in one second (FEV1) will be evaluated.
Measured: 10 weeks
Secondary outcomes (4)
Exhaled breath condensate
It will be collected 4 times during the study period (At the beginning and at the end of drug and placebo usage periods.)Cysteinyl leukotrienes, Prostaglandin D2, lipoxin levels will be measured in the exhaled breathe condensate
Measured: 14 weeks
Fractional exhaled Nitric Oxide
It's measurement will be done 4 times during the study period (At the beginning and at the end of drug and placebo usage periods.) (See flow chart).
Measured: 14 weeks
asthma control test
Measured: 14 weeks
bronchial hyperreactivity
In order to document the level of bronchial hyperreactivity of the patients, the provocholine (methacholine chloride powder for inhalation) provocation tests will be performed 4 times (At the beginning and at the end of drug and placebo usage periods)
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMar 2013
- Primary completionMay 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Cansin Sackesen, Hacettepe University
- Investigators
- Cansin Sackesen, Assoc Prof, Study chair, Hacettepe UniversityUmit M Sahiner, MD, Principal investigator, Hacettepe UniversityBetul Buyuktiryaki, MD, fellow, Principal investigator, Hacettepe UniversityOzlem Cavkaytar, MD, fellow, Principal investigator, Hacettepe UniversityEbru Arikyılmaz, MD, fellow, Principal investigator, Hacettepe UniversityAyfer Tuncer, Professor, Principal investigator, Hacettepe UniversityOzge U Soyer, Assist Prof, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618929
- Sponsor's protocol ID
- MISP Protocol 1.0
- Status last verified
- Aug 2017
- First submitted
- 12 Jun 2012
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Szefler SJ, Phillips BR, Martinez FD, Chinchilli VM, Lemanske RF, Strunk RC, Zeiger RS, Larsen G, Spahn JD, Bacharier LB, Bloomberg GR, Guilbert TW, Heldt G, Morgan WJ, Moss MH, Sorkness CA, Taussig LM. Characterization of within-subject responses to fluticasone and montelukast in childhood asthma. J Allergy Clin Immunol. 2005 Feb;115(2):233-42. doi: 10.1016/j.jaci.2004.11.014.
PubMed 15696076Rabinovitch N, Graber NJ, Chinchilli VM, Sorkness CA, Zeiger RS, Strunk RC, Bacharier LB, Martinez FD, Szefler SJ; Childhood Asthma Research and Education Network of the National Heart, Lung, and Blood Institute. Urinary leukotriene E4/exhaled nitric oxide ratio and montelukast response in childhood asthma. J Allergy Clin Immunol. 2010 Sep;126(3):545-51.e1-4. doi: 10.1016/j.jaci.2010.07.008.
PubMed 20816189
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Effects of Montelukast Treatment on Allergic Inflammation in Children With and Without Food Allergy, Single Centered, Randomised, Double Blind, Placebo Controlled Parallel Group Cross-over Study
- ClinicalTrials.gov ID
- NCT01618929
- Acronym / sponsor ID
- MISP Protocol 1.0
- Conditions
- Bronchial Asthma, Food Allergy, Children
- Keywords
- Food allergy, Asthma, Children, Montelukast, Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 Jun 2012 (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 search the effects of montelukast on the airway inflammation including FEV1%, FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge tests, the leukotriene levels in the exhaled breath condensate in asthmatic children with and without food allergy aged 6-18 years old.
- To define the patient groups with good response to montelukast and to define the parameters which predict the good response.
Detailed description
The aim of this analysis is to determine whether the children with food allergy may have more eosinophilic inflammation in the airways (as measured by FENO) or they may have Cysteinyl leukotrienes based inflammation in the airways that will be shown by high levels of Cys LT and low levels of lipoxin in the exhaled breath condensate. Our suggestion is that a special pattern of inflammation may be seen in asthmatics with food allergy because of their strong atopic march history and then we aimed to test if montelukast is more effective in children when the ratio of Cysteinyl LT inflammation is high relative to FENO (eosinophilic inflammation). This study will be the first to evaluate the effect of montelukast regarding the synthesis of Cys leukotrienes, lipoxin and FENO that will be measured from exhaled breath condensate, which is the mirror of the local inflammation in the airways in asthmatic children with atopy (food allergy). As we mentioned above another factor that we are planning to analyze is the ratio of Cys leukotriene to lipoxin, which is the natural antagonist of LT. This study will determine the ratio of Cyst LT to lipoxin and Cyst LT to FENO in the exhaled breath condensate and then there will be an analysis to see the correlation of these inflammatory markers with montelukast related changes on FEV1%, FEV1%/FVC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asthma with food allergy | Active comparator | Drug: MontelukastThe study will be performed in 2 groups of patients (Patients with and without food allergy) parallel to each other at the same time and within each group the patients will take montelukast and placebo (one after another in a double-blind design). |
| asthma without food allergy | Active comparator | Drug: MontelukastThe study will be performed in 2 groups of patients (Patients with and without food allergy) parallel to each other at the same time and within each group the patients will take montelukast and placebo (one after another in a double-blind design) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Physician diagnosed asthma (12% reversibility on spirometry test or positive response to provocholine® provocation test).
- Mild to moderate asthmatic children. Asthmatic children with pre-budesonide FEV1/FVC ≥ 80% will be included.
- At least one food allergy confirmed by specific IgE level or skin prick test positivity and a relevant clinical history or open challenge test with food.
- Aged between 6-18 years old.
- Acceptance of involvement in the study and signed informed consent (Both patients and one of the parents)
Key exclusion criteria (14 listed)
- Who does not sign the informed consent.
- Severe asthmatic children
- Any lung disease except asthma (i.e. cystic fibrosis, bronchiectasia, primary ciliary dyskinesia).
- Any systemic disease except allergic rhinitis and atopic dermatitis
- Follow-up in intensive care unit or intubation for asthma exacerbation within one year.
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 |
|---|---|---|
| MontelukastAlso: Singulair 5 mg tablets, Singulair 10 mg tablets, Placebo 5 mg tablets, Placebo 10 mg tabletsPlacebo and montelukast (5 mg for 6-14 years of age and 10 mg for 14-18 years of age once a day) will be given following one another in 4 weeks periods including a 2 weeks wash-out period in between in a cross over design. | Drug | asthma with food allergy, asthma without food allergy |
Primary outcome
the difference in FEV1% between two arms.
Time frame: 10 weeks
The asthmatic children with and without food allergy will be given placebo and montelukast following one another in a cross over design. The study will be performed in 2 groups of patients (Patients with and without food allergy) parallel to each other at the same time and within each group the patients will take montelukast and placebo. A total of 5 spirometry tests (At the beginning and end of run-in periods, at the beginning of cross-over period, at the end of wash-out period and at the end of the study) will be done and forced expiratory volume in one second (FEV1) will be evaluated.
4 secondary outcomes
Exhaled breath condensate
Time frame: 14 weeks
Fractional exhaled Nitric Oxide
Time frame: 14 weeks
asthma control test
Time frame: 14 weeks
bronchial hyperreactivity
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Background: PubMed 15696076Szefler SJ, Phillips BR, Martinez FD, Chinchilli VM, Lemanske RF, Strunk RC, Zeiger RS, Larsen G, Spahn JD, Bacharier LB, Bloomberg GR, Guilbert TW, Heldt G, Morgan WJ, Moss MH, Sorkness CA, Taussig LM. Characterization of within-subject responses to fluticasone and montelukast in childhood asthma. J Allergy Clin Immunol. 2005 Feb;115(2):233-42. doi: 10.1016/j.jaci.2004.11.014.
- Background: PubMed 20816189Rabinovitch N, Graber NJ, Chinchilli VM, Sorkness CA, Zeiger RS, Strunk RC, Bacharier LB, Martinez FD, Szefler SJ; Childhood Asthma Research and Education Network of the National Heart, Lung, and Blood Institute. Urinary leukotriene E4/exhaled nitric oxide ratio and montelukast response in childhood asthma. J Allergy Clin Immunol. 2010 Sep;126(3):545-51.e1-4. doi: 10.1016/j.jaci.2010.07.008.
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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.
Cansin Sackesen, Assoc Prof study chair
Hacettepe University
Umit M Sahiner, MD principal investigator
Hacettepe University
Betul Buyuktiryaki, MD, fellow principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Montelukast in people with Bronchial Asthma and Food Allergy, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 14 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 14 Aug 2017. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the difference in FEV1% between two arms. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01618929, which also lists 2 linked publications.
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 14 Aug 2017.