AsthmaNCT00655616
Add-on Salmeterol Versus Montelukast in Arg/Arg-16 Asthmatics
A study testing Salmeterol, Montelukast in people with Asthma, run by University of Dundee at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether patients with asthma who carry a genotype associated with adverse outcomes with long-acting beta-2 agonists like salmeterol show greater benefit from the use of an asthma drug that works via alternative pathways like montelukast. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Salmeterol, Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2007to Dec 2009
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All children and adolescents (5-18 years) with asthma in Tayside (Scotland) known:
- To carry the Arg/Arg-16 genotype and
- Currently on inhaled steroids and
- Inhaled bronchodilators according to need will be telephoned or contacted through home visits to establish if they have had:
- Any school absences from asthma or
- Out-of-hours visits to GP/hospital visits or admissions due to asthma over the previous 12 months.
Who cannot join
- The presence of serious respiratory or multi-system disease (e.g. cystic fibrosis, cancer under current treatment)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Maternal and Child Health Sciences, Ninewells Hospital and Medical School
Dundee, Tayside, DD1 9SY
About this study
Official title: A Proof-of-concept Study to Evaluate the Benefit From add-on Therapy With Montelukast Versus Salmeterol in Children With Asthma Carrying the Arg/Arg-16 beta2-receptor Genotype
The purpose of this study is to determine whether patients with asthma who carry a genotype associated with adverse outcomes with long-acting beta-2 agonists like salmeterol show greater benefit from the use of an asthma drug that works via alternative pathways like montelukast.
Read the detailed description
Background/Rationale:
The presence of the homozygous Arg/Arg genotype at position 16 of the β2-receptor (prevalence 15-17% in UK/US populations) confers relative protection against down-regulation by endogenous catecholamines, making individuals susceptible to down-regulation and desensitization by regular exogenous β2-agonists and thereby negating the benefits from the regular use of short and long acting β2-agonists in adults with asthma. We found that, in the children receiving salmeterol, the adjusted odds ratio showed a 9 fold (p=0.003) greater risk of school absences due to asthma in the Arg/Arg group in comparison to the Gly16 carriers, with an unadjusted odds ratio of 6 (p=0.009). In the cohort not receiving salmeterol, there was no evidence of any genotype-dependent increases in school absences due to asthma (odds ratio=1). In addition, the Arg/Arg children on salmeterol had a significantly increased risk of extended school absence of over 1 week from asthma with an adjusted odds ratio of 6 (p= 0.019).
Currently, British Thoracic Society/Scottish Intercollegiate Guidelines Network recommendations suggest the use of regular long-acting β2-agonists as add on therapy in children with asthma who are inadequately controlled on inhaled steroids. The guidelines suggest the use of leukotriene antagonists (e.g. montelukast) if a combination of inhaled salmeterol and inhaled steroids fail to control symptoms.
There are 1 million children with asthma in the UK. 150,000-170,000 children carry the Arg/Arg-16 genotype.
The Arg/Arg-16 children with asthma may constitute a significant population that is likely to show better asthma control with a leukotriene antagonist in comparison to long-acting β2-agonists. We have already demonstrated that school absences constitute a suitable primary outcome measure for the testing of this hypothesis.
Hypothesis:
Children with asthma carrying the Arg/Arg-16 genotype on step 2 of the BTS guidelines (inhaled steroids plus salbutamol according to need) have fewer school absences over a period of 1 year on oral montelukast compared to inhaled salmeterol
Objectives:
To perform a randomized controlled trial (parallel design) of oral montelukast versus inhaled salmeterol on children with a history of school absences/hospital admissions due to asthma over the past year using school absences from asthma over a period of 1 year as the primary outcome
Treatment Groups and Duration:
Inclusion/exclusion criteria- All children and adolescents (5-18 years) with asthma in Tayside (Scotland) known (a) to carry the Arg/Arg-16 genotype and (b) currently on inhaled steroids and (c) inhaled bronchodilators according to need will be telephoned or contacted through home visits to establish if they have had (a) any school absences from asthma or (b) out-of-hours visits to GP/hospital visits or admissions due to asthma over the previous 12 months. The presence of serious respiratory or multi-system disease (e.g. cystic fibrosis, cancer under current treatment) will constitute exclusion criteria for the study. All patients fulfilling the above inclusion and exclusion criteria will be invited to participate in the study.
Plan for each visit - First visit: (a) Documentation of patient details (b) Baseline spirometry; (c) Exhaled nitric oxide measurements (d) Respiratory quality-of-life (Juniper); (e) Saliva sample for eosinophilic cationic protein (f) discontinuation of current asthma medication for the period of the study; (g) randomization to receive either (a) Flixotide (fluticasone) as per current inhaled steroid dose (therapeutic ratio of 2:1 for beclomethasone / budesonide versus fluticasone) plus oral montelukast; or (b) Seretide (salmeterol plus equivalent dose of fluticasone) plus placebo for montelukast for a period of 1 year.
2nd -5th visits, month 3, 6, 9: 3-monthly spirometry, exhaled nitric oxide, saliva for eosinophilic cationic protein, document school absences for asthma, hospital admissions/hospital or out-of-hours GP visits over the 3-month period.
Month 12: end of study - spirometry, exhaled nitric oxide, saliva for eosinophilic cationic protein, document school absences for asthma, hospital admissions/hospital or out-of-hours GP visits over final 3-month period, measure quality-of-life.
Physical monitoring of compliance will be performed by using inhalers provided with counters and tablet dispensers that allow counting of number used.
Doses and dosage regimens:
The following doses and dosage regimens will be used for the study Seretide 100 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Seretide 250 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Seretide 500 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Flixotide Accuhaler 50 micrograms per blister, 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 100 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 250 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 500 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Doses of montelukast or placebo: upto 6 years 4 mg once daily; 6-14 years 5 mg once daily; 15 years and above 10 mg once daily.
Rescue medication: Subjects will be advised treatment with inhaled salbutamol 200 to 1000 micrograms via metered dose inhaler and volumatic device, if cough, breathlessness, increasing symptoms on exercise, or other symptoms of asthma occur. The dose will be advised to be repeated once every four to six hours. The regimen will be advised to be continued for 3-4 days, and up to a week, in case of persistence of symptoms. The research nurse conducting the study will ensure that the subject has an adequate supply of salbutamol via metered dose inhaler and large volume spacer (volumatic) at the start of the study. This will be confirmed at each visit.
Key Efficacy Parameters:
- Primary outcome: Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children
- Secondary outcomes that will also be tested:
- Oral montelukast is associated with reduced out-of hours visits/hospital visits or admissions in comparison to inhaled salmeterol over a period of 1 year
- Oral montelukast is associated with a reduction in airway resistance in comparison to inhaled salmeterol over a period of 1 year
- Oral montelukast is associated with reduced exhaled nitric oxide levels in comparison to inhaled salmeterol over a period of 1 year
- Oral montelukast is associated with reduced salivary eosinophilic cationic protein levels in comparison to inhaled salmeterol over a period of 1 year
- Oral montelukast is associated with improved asthma specific quality-of-life in comparison to inhaled salmeterol over a period of 1 year
- Oral montelukast is associated with improved morning peak expiratory flow rate in comparison to inhaled salmeterol over a period of 1 year
- Conditions
- Asthma
- Being tested
- Montelukast Placebo, Salmeterol, Montelukast
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast PlaceboDrug
Seretide 100 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast
Seretide 250 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast
Seretide 500 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast
Doses of montelukast or placebo: up to 6 years 4 mg once daily; 6-14 years 5 mg once daily; 15 years and above 10 mg once daily
Salmeterol, MontelukastDrug
Flixotide Accuhaler 50 micrograms per blister, 1 blister dose twice daily plus 1 tablet daily of montelukast
Flixotide Accuhaler 100 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast
Flixotide Accuhaler 250 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast
Flixotide Accuhaler 500 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast
Doses of montelukast or placebo: up to 6 years 4 mg once daily; 6-14 years 5 mg once daily; 15 years and above 10 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The active comparator arm consists of Flixotide® (fluticasone propionate) via accuhaler (Diskus) dry powder inhaler device as per current inhaled steroid dose plus oral montelukast Receives: Drug: Salmeterol, Montelukast |
| 2 | Placebo comparator | The placebo comparator arm consists of Seretide® (salmeterol plus equivalent dose of fluticasone) via accuhaler dry powder inhaler device as per current inhaled steroid dose plus placebo for montelukast Receives: Drug: Montelukast Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children
Measured: Every 3 months
Secondary outcomes (1)
Oral montelukast is associated with improved asthma specific quality-of-life in comparison to inhaled salmeterol over a period of 1 year
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startAug 2007
- Primary completionAug 2009
- Study completionDec 2009
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Somnath Mukhopadhyay, FRCPCH,PhD, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655616
- Sponsor's protocol ID
- sm2006msd01
- Status last verified
- Feb 2009
- First submitted
- 4 Apr 2008
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Palmer CN, Lipworth BJ, Lee S, Ismail T, Macgregor DF, Mukhopadhyay S. Arginine-16 beta2 adrenoceptor genotype predisposes to exacerbations in young asthmatics taking regular salmeterol. Thorax. 2006 Nov;61(11):940-4. doi: 10.1136/thx.2006.059386. Epub 2006 Jun 13.
PubMed 16772309Lipworth BJ, Basu K, Donald HP, Tavendale R, Macgregor DF, Ogston SA, Palmer CN, Mukhopadhyay S. Tailored second-line therapy in asthmatic children with the Arg(16) genotype. Clin Sci (Lond). 2013 Apr;124(8):521-8. doi: 10.1042/CS20120528.
PubMed 23126384
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept Study to Evaluate the Benefit From add-on Therapy With Montelukast Versus Salmeterol in Children With Asthma Carrying the Arg/Arg-16 beta2-receptor Genotype
- ClinicalTrials.gov ID
- NCT00655616
- Acronym / sponsor ID
- sm2006msd01
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Apr 2008 (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 this study is to determine whether patients with asthma who carry a genotype associated with adverse outcomes with long-acting beta-2 agonists like salmeterol show greater benefit from the use of an asthma drug that works via alternative pathways like montelukast.
Detailed description
Background/Rationale:
The presence of the homozygous Arg/Arg genotype at position 16 of the β2-receptor (prevalence 15-17% in UK/US populations) confers relative protection against down-regulation by endogenous catecholamines, making individuals susceptible to down-regulation and desensitization by regular exogenous β2-agonists and thereby negating the benefits from the regular use of short and long acting β2-agonists in adults with asthma. We found that, in the children receiving salmeterol, the adjusted odds ratio showed a 9 fold (p=0.003) greater risk of school absences due to asthma in the Arg/Arg group in comparison to the Gly16 carriers, with an unadjusted odds ratio of 6 (p=0.009). In the cohort not receiving salmeterol, there was no evidence of any genotype-dependent increases in school absences due to asthma (odds ratio=1). In addition, the Arg/Arg children on salmeterol had a significantly increased risk of extended school absence of over 1 week from asthma with an adjusted odds ratio of 6 (p= 0.019).
Currently, British Thoracic Society/Scottish Intercollegiate Guidelines Network recommendations suggest the use of regular long-acting β2-agonists as add on therapy in children with asthma who are inadequately controlled on inhaled steroids. The guidelines suggest the use of leukotriene antagonists (e.g. montelukast) if a combination of inhaled salmeterol and inhaled steroids fail to control symptoms.
There are 1 million children with asthma in the UK. 150,000-170,000 children carry the Arg/Arg-16 genotype.
The Arg/Arg-16 children with asthma may constitute a significant population that is likely to show better asthma control with a leukotriene antagonist in comparison to long-acting β2-agonists. We have already demonstrated that school absences constitute a suitable primary outcome measure for the testing of this hypothesis.
Hypothesis:
Children with asthma carrying the Arg/Arg-16 genotype on step 2 of the BTS guidelines (inhaled steroids plus salbutamol according to need) have fewer school absences over a period of 1 year on oral montelukast compared to inhaled salmeterol
Objectives:
To perform a randomized controlled trial (parallel design) of oral montelukast versus inhaled salmeterol on children with a history of school absences/hospital admissions due to asthma over the past year using school absences from asthma over a period of 1 year as the primary outcome
Treatment Groups and Duration:
Inclusion/exclusion criteria- All children and adolescents (5-18 years) with asthma in Tayside (Scotland) known (a) to carry the Arg/Arg-16 genotype and (b) currently on inhaled steroids and (c) inhaled bronchodilators according to need will be telephoned or contacted through home visits to establish if they have had (a) any school absences from asthma or (b) out-of-hours visits to GP/hospital visits or admissions due to asthma over the previous 12 months. The presence of serious respiratory or multi-system disease (e.g. cystic fibrosis, cancer under current treatment) will constitute exclusion criteria for the study. All patients fulfilling the above inclusion and exclusion criteria will be invited to participate in the study.
Plan for each visit - First visit: (a) Documentation of patient details (b) Baseline spirometry; (c) Exhaled nitric oxide measurements (d) Respiratory quality-of-life (Juniper); (e) Saliva sample for eosinophilic cationic protein (f) discontinuation of current asthma medication for the period of the study; (g) randomization to receive either (a) Flixotide (fluticasone) as per current inhaled steroid dose (therapeutic ratio of 2:1 for beclomethasone / budesonide versus fluticasone) plus oral montelukast; or (b) Seretide (salmeterol plus equivalent dose of fluticasone) plus placebo for montelukast for a period of 1 year.
2nd -5th visits, month 3, 6, 9: 3-monthly spirometry, exhaled nitric oxide, saliva for eosinophilic cationic protein, document school absences for asthma, hospital admissions/hospital or out-of-hours GP visits over the 3-month period.
Month 12: end of study - spirometry, exhaled nitric oxide, saliva for eosinophilic cationic protein, document school absences for asthma, hospital admissions/hospital or out-of-hours GP visits over final 3-month period, measure quality-of-life.
Physical monitoring of compliance will be performed by using inhalers provided with counters and tablet dispensers that allow counting of number used.
Doses and dosage regimens:
The following doses and dosage regimens will be used for the study Seretide 100 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Seretide 250 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Seretide 500 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Flixotide Accuhaler 50 micrograms per blister, 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 100 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 250 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 500 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Doses of montelukast or placebo: upto 6 years 4 mg once daily; 6-14 years 5 mg once daily; 15 years and above 10 mg once daily.
Rescue medication: Subjects will be advised treatment with inhaled salbutamol 200 to 1000 micrograms via metered dose inhaler and volumatic device, if cough, breathlessness, increasing symptoms on exercise, or other symptoms of asthma occur. The dose will be advised to be repeated once every four to six hours. The regimen will be advised to be continued for 3-4 days, and up to a week, in case of persistence of symptoms. The research nurse conducting the study will ensure that the subject has an adequate supply of salbutamol via metered dose inhaler and large volume spacer (volumatic) at the start of the study. This will be confirmed at each visit.
Key Efficacy Parameters:
- Primary outcome: Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children
- Secondary outcomes that will also be tested:
- Oral montelukast is associated with reduced out-of hours visits/hospital visits or admissions in comparison to inhaled salmeterol over a period of 1 year
- Oral montelukast is associated with a reduction in airway resistance in comparison to inhaled salmeterol over a period of 1 year
- Oral montelukast is associated with reduced exhaled nitric oxide levels in comparison to inhaled salmeterol over a period of 1 year
- Oral montelukast is associated with reduced salivary eosinophilic cationic protein levels in comparison to inhaled salmeterol over a period of 1 year
- Oral montelukast is associated with improved asthma specific quality-of-life in comparison to inhaled salmeterol over a period of 1 year
- Oral montelukast is associated with improved morning peak expiratory flow rate in comparison to inhaled salmeterol over a period of 1 year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Salmeterol, MontelukastThe active comparator arm consists of Flixotide® (fluticasone propionate) via accuhaler (Diskus) dry powder inhaler device as per current inhaled steroid dose plus oral montelukast |
| 2 | Placebo comparator | Drug: Montelukast PlaceboThe placebo comparator arm consists of Seretide® (salmeterol plus equivalent dose of fluticasone) via accuhaler dry powder inhaler device as per current inhaled steroid dose plus placebo for montelukast |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- To carry the Arg/Arg-16 genotype and
- Currently on inhaled steroids and
- Inhaled bronchodilators according to need will be telephoned or contacted through home visits to establish if they have had:
Key exclusion criteria (1 listed)
- The presence of serious respiratory or multi-system disease (e.g. cystic fibrosis, cancer under current treatment)
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 PlaceboSeretide 100 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Seretide 250 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Seretide 500 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Doses of montelukast or placebo: up to 6 years 4 mg once daily; 6-14 years 5 mg once daily; 15 years and above 10 mg once daily | Drug | 2 |
| Salmeterol, MontelukastFlixotide Accuhaler 50 micrograms per blister, 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 100 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 250 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 500 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Doses of montelukast or placebo: up to 6 years 4 mg once daily; 6-14 years 5 mg once daily; 15 years and above 10 mg once daily | Drug | 1 |
Primary outcome
Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children
Time frame: Every 3 months
1 secondary outcome
Oral montelukast is associated with improved asthma specific quality-of-life in comparison to inhaled salmeterol over a period of 1 year
Time frame: Every 3 months
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 24 Mar 2011.
- Background: PubMed 16772309Palmer CN, Lipworth BJ, Lee S, Ismail T, Macgregor DF, Mukhopadhyay S. Arginine-16 beta2 adrenoceptor genotype predisposes to exacerbations in young asthmatics taking regular salmeterol. Thorax. 2006 Nov;61(11):940-4. doi: 10.1136/thx.2006.059386. Epub 2006 Jun 13.
- Derived from this study: PubMed 23126384Lipworth BJ, Basu K, Donald HP, Tavendale R, Macgregor DF, Ogston SA, Palmer CN, Mukhopadhyay S. Tailored second-line therapy in asthmatic children with the Arg(16) genotype. Clin Sci (Lond). 2013 Apr;124(8):521-8. doi: 10.1042/CS20120528.
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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.
Somnath Mukhopadhyay, FRCPCH,PhD principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salmeterol, Montelukast in people with Asthma, run by University of Dundee at 1 site in United Kingdom.
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 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 24 Mar 2011. 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 United Kingdom. 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.
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?
Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children (time frame: Every 3 months). 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 NCT00655616, 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 24 Mar 2011.