Lung Disease, ObstructivePhase 4MontelukastNCT00934713
The Effect of Montelukast Treatment in Wheezy Infants
A Phase 4 study testing montelukast in people with Lung Disease, Obstructive and Signs and Symptoms, Respiratory, run by University of Helsinki at 1 site in Finland.
Trial summary
The study is designed to evaluate the efficacy of montelukast on symptom-free days in unselected group of very young children with wheeze and recurrent asthma like symptoms. The secondary aim was to evaluate the effect of montelukast on lung function, airway responsiveness, airway inflammation and use of rescue… Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Lung Disease, Obstructive, Signs and Symptoms, Respiratory
- What is being tested?
- montelukast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2004to Apr 2008
- 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 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- at least one physician-diagnosed wheezing episode and history of recurrent cough, dyspnoea and wheeze and successfully performed methacholine challenge test were included.
Who cannot join
- use of ICS within 8 weeks prior to the first visit, a cumulative life-time systemic prednisolone use more than 3 days at a dose of 2 mg/kg, an equipotent dose of another systemic corticosteroid or ICS use more than 4 weeks, respiratory infection in the 14 days preceding lung function measurement and obvious tracheobronchomalacia or other structural defect.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Skin and Allergy Hospital, Helsinki University Central Hospital
Helsinki, P.O.Box 160, FIN-00029 HUS
About this study
Official title: The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children
The study is designed to evaluate the efficacy of montelukast on symptom-free days in unselected group of very young children with wheeze and recurrent asthma like symptoms. The secondary aim was to evaluate the effect of montelukast on lung function, airway responsiveness, airway inflammation and use of rescue medication.
Read the detailed description
The aim of this study was to investigate the effectiveness of montelukast in wheezy very young children with persistent respiratory symptoms. This study was a prospective, double-blind, placebo-controlled study of 6 to 24 months old children, who had at least one physician-diagnosed wheezing episode and persistent asthmatic symptoms. Patients were randomised to placebo or montelukast 4 mg / day for 8 weeks period. The clinical response to treatment was determined, the functional residual capacity (FRC) and specific air-way conductance (sGaw) was measured using an infant whole-body pletys-mograph, the maximal flow at functional residual capacity (V´maxFRC) was re-corded using the squeeze technique and airway responsiveness was evaluated by performing a dosimetric methacholine challenge test.
- Being tested
- montelukast
- Keywords
- montelukast, very young children, lung function tests
- Medical subject headings
- Lung Diseases, Obstructive, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukastDrug
Also called singulair
montelukast 4mg once per day for 8 weeks period
| Study group | Role | What they receive |
|---|---|---|
| montelukast | Active comparator | montelukast 4 mg once per day for 8 weeks Receives: Drug: montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom free days
Measured: 2 weeks runin and 8 weeks treatment
Secondary outcomes (1)
lung function, airway responsiveness, exhale nitric oxide, use of rescue medication
Measured: before and after 8 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startSep 2004
- Primary completionApr 2008
- Study completionApr 2008
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 Lung Disease, ObstructiveStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Anna S Pelkonen, MD, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934713
- Sponsor's protocol ID
- 33902
- Acronym
- Montelukast
- Status last verified
- Oct 2003
- First submitted
- 7 Jul 2009
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Pelkonen AS, Malmstrom K, Sarna S, Kajosaari M, Klemola T, Malmberg LP, Makela MJ. The effect of montelukast on respiratory symptoms and lung function in wheezy infants. Eur Respir J. 2013 Mar;41(3):664-70. doi: 10.1183/09031936.00173411. Epub 2012 Jul 12.
PubMed 23060628
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Montelukast Therapy on Respiratory Symptoms, Lung Function and Airway Responsiveness in Wheezy Very Young Children
- ClinicalTrials.gov ID
- NCT00934713
- Acronym / sponsor ID
- Montelukast / 33902
- Keywords
- montelukast, very young children, lung function tests
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2004
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Jul 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.
The study is designed to evaluate the efficacy of montelukast on symptom-free days in unselected group of very young children with wheeze and recurrent asthma like symptoms. The secondary aim was to evaluate the effect of montelukast on lung function, airway responsiveness, airway inflammation and use of rescue medication.
Detailed description
The aim of this study was to investigate the effectiveness of montelukast in wheezy very young children with persistent respiratory symptoms. This study was a prospective, double-blind, placebo-controlled study of 6 to 24 months old children, who had at least one physician-diagnosed wheezing episode and persistent asthmatic symptoms. Patients were randomised to placebo or montelukast 4 mg / day for 8 weeks period. The clinical response to treatment was determined, the functional residual capacity (FRC) and specific air-way conductance (sGaw) was measured using an infant whole-body pletys-mograph, the maximal flow at functional residual capacity (V´maxFRC) was re-corded using the squeeze technique and airway responsiveness was evaluated by performing a dosimetric methacholine challenge test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| montelukast | Active comparator | Drug: montelukastmontelukast 4 mg once per day for 8 weeks |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- at least one physician-diagnosed wheezing episode and history of recurrent cough, dyspnoea and wheeze and successfully performed methacholine challenge test were included.
Key exclusion criteria (1 listed)
- use of ICS within 8 weeks prior to the first visit, a cumulative life-time systemic prednisolone use more than 3 days at a dose of 2 mg/kg, an equipotent dose of another systemic corticosteroid or ICS use more than 4 weeks, respiratory infection in the 14 days preceding lung function measurement and obvious tracheobronchomalacia or other structural defect.
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: singulairmontelukast 4mg once per day for 8 weeks period | Drug | montelukast |
Primary outcome
symptom free days
Time frame: 2 weeks runin and 8 weeks treatment
1 secondary outcome
lung function, airway responsiveness, exhale nitric oxide, use of rescue medication
Time frame: before and after 8 weeks treatment
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 8 Jul 2009.
- Derived from this study: PubMed 23060628Pelkonen AS, Malmstrom K, Sarna S, Kajosaari M, Klemola T, Malmberg LP, Makela MJ. The effect of montelukast on respiratory symptoms and lung function in wheezy infants. Eur Respir J. 2013 Mar;41(3):664-70. doi: 10.1183/09031936.00173411. Epub 2012 Jul 12.
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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.
Anna S Pelkonen, MD study chair
Helsinki University Central Hospital
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 Lung Disease, Obstructive and Signs and Symptoms, Respiratory, run by University of Helsinki at 1 site in Finland.
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 1 inclusion and 1 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 8 Jul 2009. 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 Finland. 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?
symptom free days (time frame: 2 weeks runin and 8 weeks treatment). 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 NCT00934713, 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 8 Jul 2009.