AsthmaPhase 4NCT00196547
Montelukast in Modulating Exacerbations of Asthma in Children
A Phase 4 study testing Montelukast (drug) in people with Asthma, run by Firestone Institute for Respiratory Health at 1 site in Canada.
Trial summary
The purpose of the study is to determine if Montelukast added to other therapy, if any, will reduce the severity of asthma symptoms in children during the high incidence of respiratory viral infections that occur in children in the post Labor Day school return period. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Asthma
- What is being tested?
- Montelukast (drug)
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Nov 2005
- 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2-14 years inclusive
- Doctor-diagnosed asthma
- Needing a beta-agonist inhaler at least once weekly on average for symptom relief
- At least one day lost from school in the past year, or significantly limited activity, because of asthma
- A history of asthma exacerbations associated with apparent respiratory viral infections
- Parent or guardian who is willing to provide informed consent
- Willing to give assent
Who cannot join
- Non-English speaking
- Unable to understand purpose of study and give consent
- Concomitant respiratory or other major illness e.g. cystic fibrosis, cardiac disease
- Currently using montelukast or other leukotriene receptor antagonist
- Using regular oral corticosteroid
- An asthma exacerbation requiring medical intervention during August 2005
Trial locations and contacts
1 site in 1 country.
Canada1 site
Firestone Institute for Respiratory Health
Hamilton, Ontario, L8N 4A6
About this study
Official title: Randomized Placebo-controlled Trial of Montelukast in Modulating Exacerbations of Asthma in Children, September 2005
The purpose of the study is to determine if Montelukast added to other therapy, if any, will reduce the severity of asthma symptoms in children during the high incidence of respiratory viral infections that occur in children in the post Labor Day school return period.
Read the detailed description
Between 1990- and 2003, we identified in Ontario, and subsequently across Canada, a striking increase in hospital admissions for asthma in children occurring predictably in the third week of September every year.1 In 2000 we undertook a retrospective case-control study comparing the clinical characteristics of children using local emergency rooms for asthma in September, with those of children presenting during the non-epidemic months of July-August. Based on that pilot study of 169 children, we developed a larger prospective case-control study of clinical and biological characteristics of children recruited as they presented to an emergency room for asthma during September 2001. The control group for this study were children recruited from the community who had symptomatic asthma but did not have a September exacerbation requiring emergency room utilization. We identified the presence of rhinovirus in the majority of children attending an ER with acute asthma, and also found rhinovirus in a substantial proportion of the community based controls. We also found a highly significant difference in use of medications for asthma, with the ER cases being much less likely to be receiving adequate anti-inflammatory medication. In September 2004 we conducted a pilot randomized controlled blinded clinical trial of the efficacy of montelukast in reducing morbidity caused by asthma exacerbations associated with respiratory viral infections (RVI) in children aged 2 to 14. We found a highly significant reduction in reported symptom free days in the montelukast group. The current study is a randomized placebo-controlled trial of montelukast, during September 2005 to confirm the results of our pilot study and to examine the effectiveness of montelukast in reducing asthma morbidity during RVIs in different age and sex groups with a range of risk of exacerbations. We also wish to compare the effectiveness of montelukast to placebo in reducing asthma morbidity during RVIs between groups of children concurrently taking no or other classes of asthma control medications.
- Conditions
- Asthma
- Being tested
- Montelukast (drug)
- Keywords
- Asthma, Respiratory viral infections, Exacerbations, Pediatric, Leukotriene receptor antagonists, School
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily asthma symptom score
Secondary outcomes (2)
Unscheduled physician visits (including ER)
Oral-cortico-steroid use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Firestone Institute for Respiratory Health
- Sponsor type
- University, hospital or other
- Investigators
- Malcolm R Sears, MB. ChB, Principal investigator, Firestone Institute for Respiratory Health, St. Joseph's Healthcare, HamiltonNeil W Johnston, MSc, Study director, Firestone Institute for Respiratory Health, St. Joseph's Healthcare, Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196547
- Sponsor's protocol ID
- R.P. #05-2440
- Status last verified
- Mar 2012
- First submitted
- 12 Sep 2005
- Last updated
- 16 Mar 2012
- Results posted
- No
Publications
Johnston NW, Johnston SL, Duncan JM, Greene JM, Kebadze T, Keith PK, Roy M, Waserman S, Sears MR. The September epidemic of asthma exacerbations in children: a search for etiology. J Allergy Clin Immunol. 2005 Jan;115(1):132-8. doi: 10.1016/j.jaci.2004.09.025.
PubMed 15637559Bisgaard H, Zielen S, Garcia-Garcia ML, Johnston SL, Gilles L, Menten J, Tozzi CA, Polos P. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005 Feb 15;171(4):315-22. doi: 10.1164/rccm.200407-894OC. Epub 2004 Nov 12.
PubMed 15542792Johnston NW, Mandhane PJ, Dai J, Duncan JM, Greene JM, Lambert K, Sears MR. Attenuation of the September epidemic of asthma exacerbations in children: a randomized, controlled trial of montelukast added to usual therapy. Pediatrics. 2007 Sep;120(3):e702-12. doi: 10.1542/peds.2006-3317.
PubMed 17766511
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Trial of Montelukast in Modulating Exacerbations of Asthma in Children, September 2005
- ClinicalTrials.gov ID
- NCT00196547
- Acronym / sponsor ID
- R.P. #05-2440
- Conditions
- Asthma
- Keywords
- Asthma, Respiratory viral infections, Exacerbations, Pediatric, Leukotriene receptor antagonists, School
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Firestone Institute for Respiratory HealthUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Nov 2005
- First posted
- 20 Sep 2005 (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.
The purpose of the study is to determine if Montelukast added to other therapy, if any, will reduce the severity of asthma symptoms in children during the high incidence of respiratory viral infections that occur in children in the post Labor Day school return period.
Detailed description
Between 1990- and 2003, we identified in Ontario, and subsequently across Canada, a striking increase in hospital admissions for asthma in children occurring predictably in the third week of September every year.1 In 2000 we undertook a retrospective case-control study comparing the clinical characteristics of children using local emergency rooms for asthma in September, with those of children presenting during the non-epidemic months of July-August. Based on that pilot study of 169 children, we developed a larger prospective case-control study of clinical and biological characteristics of children recruited as they presented to an emergency room for asthma during September 2001. The control group for this study were children recruited from the community who had symptomatic asthma but did not have a September exacerbation requiring emergency room utilization. We identified the presence of rhinovirus in the majority of children attending an ER with acute asthma, and also found rhinovirus in a substantial proportion of the community based controls. We also found a highly significant difference in use of medications for asthma, with the ER cases being much less likely to be receiving adequate anti-inflammatory medication. In September 2004 we conducted a pilot randomized controlled blinded clinical trial of the efficacy of montelukast in reducing morbidity caused by asthma exacerbations associated with respiratory viral infections (RVI) in children aged 2 to 14. We found a highly significant reduction in reported symptom free days in the montelukast group. The current study is a randomized placebo-controlled trial of montelukast, during September 2005 to confirm the results of our pilot study and to examine the effectiveness of montelukast in reducing asthma morbidity during RVIs in different age and sex groups with a range of risk of exacerbations. We also wish to compare the effectiveness of montelukast to placebo in reducing asthma morbidity during RVIs between groups of children concurrently taking no or other classes of asthma control medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 2-14 years inclusive
- Doctor-diagnosed asthma
- Needing a beta-agonist inhaler at least once weekly on average for symptom relief
- At least one day lost from school in the past year, or significantly limited activity, because of asthma
- A history of asthma exacerbations associated with apparent respiratory viral infections
Key exclusion criteria (6 listed)
- Non-English speaking
- Unable to understand purpose of study and give consent
- Concomitant respiratory or other major illness e.g. cystic fibrosis, cardiac disease
- Currently using montelukast or other leukotriene receptor antagonist
- Using regular oral corticosteroid
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 (drug) | Drug | – |
Primary outcome
Daily asthma symptom score
2 secondary outcomes
Unscheduled physician visits (including ER)
Oral-cortico-steroid use
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 16 Mar 2012.
- Background: PubMed 15637559Johnston NW, Johnston SL, Duncan JM, Greene JM, Kebadze T, Keith PK, Roy M, Waserman S, Sears MR. The September epidemic of asthma exacerbations in children: a search for etiology. J Allergy Clin Immunol. 2005 Jan;115(1):132-8. doi: 10.1016/j.jaci.2004.09.025.
- Background: PubMed 15542792Bisgaard H, Zielen S, Garcia-Garcia ML, Johnston SL, Gilles L, Menten J, Tozzi CA, Polos P. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005 Feb 15;171(4):315-22. doi: 10.1164/rccm.200407-894OC. Epub 2004 Nov 12.
- Derived from this study: PubMed 17766511Johnston NW, Mandhane PJ, Dai J, Duncan JM, Greene JM, Lambert K, Sears MR. Attenuation of the September epidemic of asthma exacerbations in children: a randomized, controlled trial of montelukast added to usual therapy. Pediatrics. 2007 Sep;120(3):e702-12. doi: 10.1542/peds.2006-3317.
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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.
Malcolm R Sears, MB. ChB principal investigator
Firestone Institute for Respiratory Health, St. Joseph's Healthcare, Hamilton
Neil W Johnston, MSc study director
Firestone Institute for Respiratory Health, St. Joseph's Healthcare, Hamilton
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 (drug) in people with Asthma, run by Firestone Institute for Respiratory Health at 1 site in Canada.
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 7 inclusion and 6 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 16 Mar 2012. 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 Canada. 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?
Daily asthma symptom score. 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 NCT00196547, which also lists 3 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 16 Mar 2012.