AsthmaPhase 4MORACHNCT00875082
Effect of Montelukast on Remodelling Markers in Asthmatic Children
A Phase 4 study testing Montelukast in people with Asthma, run by Universita di Verona at 1 site in Italy.
Trial summary
Airway smooth muscle cell layer thickening and sub epithelial fibrosis, key allergen-induced airway remodelling features not modulated by corticosteroids, are reversible by CysLT1 receptor blockade therapy in animals. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Asthma
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2010to Apr 2013
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnostic criteria: the classification of asthma will be based on clinical history and examination and pulmonary function parameters, according to international guidelines.
- Stage and/or severity of condition: atopic children with mild intermittent asthma will be enrolled. Atopy will be evaluated by skin-prick test to common allergens in the area.
- Confirmatory physical and laboratory findings:
- Age: ranging in age 6 to 14 years.
- Evidence of susceptibility to the disease under study
- Patients have not used ICS during 3-month period prior to study entry
Who cannot join
- Patients will be excluded if they had used oral steroids in the last month.
- Patients will be excluded if they had acute or chronic lung diseases other than asthma, upper or lower airway infection in the previous 3 weeks or during the trial, acute asthma exacerbation, or had used oral steroids in the last month.
- Patients will be excluded if they had acute or chronic lung diseases other than asthma, upper or lower airway infections in the previous 3 weeks or during the trial, acute asthma exacerbation, or had used oral steroids in the last month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Montelukast on Metalloproteinase (MMP)-9, MMP-12, Tissue Inhibitor Metalloproteinase-1 (TIMP-1), Procollagen Type I C-terminal Peptide (PICP) and TGF-beta1 Levels in Sputum From Mild Intermittent Asthmatic Children: a Pilot Study
Airway smooth muscle cell layer thickening and sub epithelial fibrosis, key allergen-induced airway remodelling features not modulated by corticosteroids, are reversible by CysLT1 receptor blockade therapy in animals. No data are available, at the present, about the potential effect of LTs receptor antagonists on airway remodelling in asthmatic children.
In the present study, the investigators aim to assess whether the addition of montelukast to ICS in mild asthmatic children to inhibit the release of MMP-9, TIMP-1, MMP-12, MMP-9/TIMP1 ratio, procollagen type I C-terminal peptide (PICP) and TGF-beta in the airway fluid collected by induced sputum in asthmatic children. 30-40 atopic children with mild persistent asthma.
Read more
Children with asthma will be recruited and evaluated with a real life open label trial: they will be randomised into two groups at first visit (T1): 1) group A: in these patients montelukast tablets 5 mg and as needed beta agonist will be administered; 2) group B: in these patients beta agonist therapy only.
All children will be evaluated after 8 weeks (T2). They will be tested for lung function, FeNO, metalloproteinase (MMP)-9, MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1), procollagen type I C-terminal peptide (PICP) and TGF-beta1 levels in sputum.
- Conditions
- Asthma
- Being tested
- Montelukast, placebo
- Keywords
- Asthma, Children, Remodelling, Metalloproteinases, Montelukast
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Montelukast, chewing tablets 5mg, once daily, 8 weeks
placeboDrug
placebo chewing tablets once daily, plus inhaled short acting beta2 agonist as needed, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Active comparator | Montelukast chewing tablets once daily per os, plus inhaled short acting beta2 agonist as needed Receives: Drug: Montelukast |
| placebo | Placebo comparator | placebo chewing tablets per os once daily, plus inhaled short acting beta 2 agonist as needed Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FeNo, Lung Function, MMP-9, MMP-12, TIMP-1, PICP and TGFB determination
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boner Attilio, Universita di Verona
- Investigators
- Attilio L Boner, MD, Principal investigator, Pediatric Department, Università di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875082
- Sponsor's protocol ID
- UVAB-02
- Acronym
- MORACH
- Status last verified
- Jun 2013
- First submitted
- 2 Apr 2009
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tenero L, Piazza M, Sandri M, Azzali A, Chinellato I, Peroni D, Boner A, Piacentini G. Effect of montelukast on markers of airway remodeling in children with asthma. Allergy Asthma Proc. 2016 Sep;37(5):77-83. doi: 10.2500/aap.2016.37.3978.
PubMed 27657514
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Montelukast on Metalloproteinase (MMP)-9, MMP-12, Tissue Inhibitor Metalloproteinase-1 (TIMP-1), Procollagen Type I C-terminal Peptide (PICP) and TGF-beta1 Levels in Sputum From Mild Intermittent Asthmatic Children: a Pilot Study
- ClinicalTrials.gov ID
- NCT00875082
- Acronym / sponsor ID
- MORACH / UVAB-02
- Conditions
- Asthma
- Keywords
- Asthma, Children, Remodelling, Metalloproteinases, Montelukast
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Apr 2009 (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.
Airway smooth muscle cell layer thickening and sub epithelial fibrosis, key allergen-induced airway remodelling features not modulated by corticosteroids, are reversible by CysLT1 receptor blockade therapy in animals. No data are available, at the present, about the potential effect of LTs receptor antagonists on airway remodelling in asthmatic children.
In the present study, the investigators aim to assess whether the addition of montelukast to ICS in mild asthmatic children to inhibit the release of MMP-9, TIMP-1, MMP-12, MMP-9/TIMP1 ratio, procollagen type I C-terminal peptide (PICP) and TGF-beta in the airway fluid collected by induced sputum in asthmatic children. 30-40 atopic children with mild persistent asthma.
Children with asthma will be recruited and evaluated with a real life open label trial: they will be randomised into two groups at first visit (T1): 1) group A: in these patients montelukast tablets 5 mg and as needed beta agonist will be administered; 2) group B: in these patients beta agonist therapy only.
All children will be evaluated after 8 weeks (T2). They will be tested for lung function, FeNO, metalloproteinase (MMP)-9, MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1), procollagen type I C-terminal peptide (PICP) and TGF-beta1 levels in sputum.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Active comparator | Drug: MontelukastMontelukast chewing tablets once daily per os, plus inhaled short acting beta2 agonist as needed |
| placebo | Placebo comparator | Drug: placeboplacebo chewing tablets per os once daily, plus inhaled short acting beta 2 agonist as needed |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnostic criteria: the classification of asthma will be based on clinical history and examination and pulmonary function parameters, according to international guidelines.
- Stage and/or severity of condition: atopic children with mild intermittent asthma will be enrolled. Atopy will be evaluated by skin-prick test to common allergens in the area.
- Confirmatory physical and laboratory findings:
- Age: ranging in age 6 to 14 years.
- Evidence of susceptibility to the disease under study
Key exclusion criteria (3 listed)
- Patients will be excluded if they had used oral steroids in the last month.
- Patients will be excluded if they had acute or chronic lung diseases other than asthma, upper or lower airway infection in the previous 3 weeks or during the trial, acute asthma exacerbation, or had used oral steroids in the last month.
- Patients will be excluded if they had acute or chronic lung diseases other than asthma, upper or lower airway infections in the previous 3 weeks or during the trial, acute asthma exacerbation, or had used oral steroids in the last month.
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 |
|---|---|---|
| MontelukastMontelukast, chewing tablets 5mg, once daily, 8 weeks | Drug | Montelukast |
| placeboplacebo chewing tablets once daily, plus inhaled short acting beta2 agonist as needed, 8 weeks | Drug | placebo |
Primary outcome
FeNo, Lung Function, MMP-9, MMP-12, TIMP-1, PICP and TGFB determination
Time frame: 8 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 19 Jun 2013.
- Derived from this study: PubMed 27657514Tenero L, Piazza M, Sandri M, Azzali A, Chinellato I, Peroni D, Boner A, Piacentini G. Effect of montelukast on markers of airway remodeling in children with asthma. Allergy Asthma Proc. 2016 Sep;37(5):77-83. doi: 10.2500/aap.2016.37.3978.
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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.
Attilio L Boner, MD principal investigator
Pediatric Department, Università di Verona
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 Asthma, run by Universita di Verona at 1 site in Italy.
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 6 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 19 Jun 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 Italy. 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 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?
FeNo, Lung Function, MMP-9, MMP-12, TIMP-1, PICP and TGFB determination (time frame: 8 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 NCT00875082, which also lists 1 linked publication.
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 19 Jun 2013.