WheezingPhase 3WAITNCT01142505
Wheeze and Intermittent Treatment
A Phase 3 study testing Mannitol and Montelukast in people with Wheezing, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
The clinical aim of this trial is to assess whether intermittent montelukast is an effective treatment strategy in preschool wheeze. The mechanisms aim of the trial is to determine whether there is a genetically highly-responsive subgroup of children. Read more about this study
- Who is it for?
- Ages 10 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Wheezing
- What is being tested?
- Mannitol and Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,358 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Feb 2014
- Phase
- Phase 3
- 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 10 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age ≥ 10 months and ≤ 5 years old on the day of the first dose of Investigational Medicinal Product
- two or more attacks of parent-reported wheeze
- at least one attack with wheeze validated by a clinician
- the most recent attack within the last 3 months
- contactable by telephone and able to attend one face-to-face review for issue of Investigational Medicinal Product
- parent or guardian able to give written informed consent for their child to participate in the study
Who cannot join
- any other chronic respiratory condition diagnosed by a clinician including structural airway abnormality (e.g. floppy larynx) and cystic fibrosis
- any chronic condition that increases vulnerability to respiratory tract infection such as severe developmental delay with feeding difficulty
- history of neonatal chronic lung disease
- current continuous oral montelukast therapy
- in a trial using an Investigational Medicinal Product in the previous 3 months prior to recruitment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parent-determined Oral Montelukast Therapy for Preschool Wheeze With Stratification for Arachidonate-5-Lipoxygenase (ALOX5) Promoter Genotype
The clinical aim of this trial is to assess whether intermittent montelukast is an effective treatment strategy in preschool wheeze. The mechanisms aim of the trial is to determine whether there is a genetically highly-responsive subgroup of children. In designing this trial the investigators have incorporated several novel aspects. First, parents will be able to adjust the use of oral montelukast to their child's symptoms. This allows the investigators to recruit both "episodic" and "multi trigger" patterns of preschool wheeze - and control for any change in wheeze pattern during the trial. Second, before the investigators issue the trial medication, the investigators will assess children's leukotriene genes, focusing primarily on a gene called ALOX5. This ALOX5 "stratification" step will ensure that an equal number of potentially "treatment-responsive" children receive the active drug (montelukast) and the dummy medicine - and the equal numbers will help the investigators to assess the role of ALOX5. For the trial, the investigators will first recruit 1,300 children with a history of preschool wheeze, then divide them into the group with "responsive" and "less responsive" genes by their ALOX5 status. The investigators will then issue parents with the trial medication; 50% will be given montelukast and 50% will be given dummy medication. Parents will start the trial medication whenever their child develops a cold, and stop the medication when wheeze resolve. Parents will also be able to give the trial medication for wheeze between colds. Over the 12 month trial period, the investigators will assess the number of unscheduled attendances to a medical practitioner for wheeze for each child. At the end of the trial, the investigators will determine whether montelukast is effective then whether there is a difference in response to montelukast between the 2 ALOX5 gene groups.
At the same time, the investigators will measure many other genes that may influence response to montelukast, as well as the amount of leukotrienes that are excreted in the urine before and during attacks. Using these results, the investigators will be able to both inform national treatment policy, and develop new concepts on the mechanism of preschool wheeze that will inform the development of new therapies. Since children will continue to receive "normal" inhaled therapy, there are no ethical issues in giving a dummy medicine to half of the 1300 children to be recruited. The study will be the largest trial in wheezy preschool children to date, and may open up genetic testing in preschool wheeze.
Read the detailed description
Background
A quarter of all UK children will have at least one attack of wheeze during the preschool period (1 to 5 years of age). Severe attacks of wheeze in these young children are usually triggered by viral-colds. The majority of affected children will only wheeze with colds, although these attacks may be severe and repeated resulting in GP attendances and hospital admissions. This pattern of wheeze is called "episodic" preschool wheeze. A minority of preschool children wheeze both with and between colds - a pattern that is called "multi-trigger" preschool wheeze. In real life this distinction is blurred, with preschool children changing their pattern of wheeze over time. What is clear is that asthma therapies that are effective in older children with classical "allergic" asthma may not necessarily be effective in preschool wheeze. For example, although a short-course of oral steroids is very effective in treating attacks of wheeze in school age children with "allergic" asthma, the investigators have shown in 2 major trials that a short course of oral steroids does not reduce the severity of attacks of preschool wheeze.
Recently, montelukast, an oral medicine that blocks a substance (leukotriene) that narrows the breathing tubes, has shown promise in preschool wheeze. However, to date, only modest benefits have been reported when large groups of children have been studied. One explanation for this, is that a significant proportion of preschool children do not respond to montelukast, but there is a subgroup who are genetically programmed to respond very well. Recent analysis of trials of montelukast suggests that this responsive subgroup may be defined by variations in leukotriene-producing genes. Thus an understanding of the role of leukotriene genes and leukotriene production in preschool wheeze may better target montelukast treatment in this age group, and inform the development of new therapies.
Trial Description
The clinical aim of this trial is to assess whether intermittent montelukast is an effective treatment strategy in preschool wheeze. The mechanisms aim of the trial is to determine whether there is a genetically highly-responsive subgroup of children. In designing this trial the investigators have incorporated several novel aspects. First, parents will be able to adjust the use of oral montelukast to their child's symptoms. This allows us to recruit both "episodic" and "multi trigger" patterns of preschool wheeze - and control for any change in wheeze pattern during the trial. Second, before the investigators issue the trial medication, the investigators will assess children's leukotriene genes, focusing primarily on a gene called ALOX5. This ALOX5 "stratification" step will ensure that an equal number of potentially "treatment-responsive" children receive the active drug (montelukast) and the dummy medicine - and the equal numbers will help us to assess the role of ALOX5. For the trial, the investigators will first recruit 1,300 children with a history of preschool wheeze, then divide them into the group with "responsive" and "less responsive" genes by their ALOX5 status. The investigators will then issue parents with the trial medication; 50% will be given montelukast and 50% will be given dummy medication. Parents will start the trial medication whenever their child develops a cold, and stop the medication when wheeze resolve. Parents will also be able to give the trial medication for wheeze between colds. Over the 12 month trial period, the investigators will assess the number of unscheduled attendances to a medical practitioner for wheeze for each child. At the end of the trial, the investigators will determine whether montelukast is effective then whether there is a difference in response to montelukast between the 2 ALOX5 gene groups.
At the same time, the investigators will measure many other genes that may influence response to montelukast, as well as the amount of leukotrienes that are excreted in the urine before and during attacks. Using these results, the investigators will be able to both inform national treatment policy, and develop new concepts on the mechanism of preschool wheeze that will inform the development of new therapies. Since children will continue to receive "normal" inhaled therapy, there are no ethical issues in giving a dummy medicine to half of the 1300 children to be recruited. The study will be the largest trial in wheezy preschool children to date, and may open up genetic testing in preschool wheeze.
- Conditions
- Wheezing
- Being tested
- Mannitol, Montelukast
- Keywords
- wheeze, preschool, leukotriene, montelukast, 5-lipoxygenase
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
Also called Pearlitol SD 200
4mg once daily granules for 10 days, given orally alone or with cold or warm food from the onset of a cold or wheezing attack.
MontelukastDrug
Also called Singulair
4mg once daily granules for 10 days, given orally alone or with cold or warm food from the onset of a cold or wheezing attack
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients in the placebo arm will be given an inactive version of the investigational medical product formed of the excipient mannitol (which is coated with the active drug montelukast in the active comparator arm) Receives: Drug: Mannitol |
| Montelukast | Active comparator | Patients in the active arm will be given an active version of the investigational medical product formed of the inactive excipient mannitol with a coating of active drug montelukast. Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for unscheduled medical attention
Number of times a child attends for an unscheduled medical opinion with respiratory problems over a 12 month period, as confirmed from medical records.
Measured: 12 months
Secondary outcomes (7)
Number of admissions to hospital
Measured: 12 months
Duration of admissions to hospital
Measured: 12 months
Number of unscheduled GP consultations for wheeze
The number of times a child is brought to his primary care/family doctor with wheeze
Measured: 12 months
Duration of wheezy episodes
The duration of wheezy episodes as recorded by parents on their diary cards.
Measured: 12 months
Severity of episodes by diary card
The severity of wheeze episodes as recorded in parent diary cards
Measured: 12 months
Parent's overall impression of efficacy of Investigational Medicinal Product
Parent's overall impression of efficacy of Investigational Medicinal Product as recorded in diary cards.
Measured: 12 months
Time to first attack of wheeze
Time to first attack of wheeze as recorded in parent diary card and researcher phonecalls.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2014
- Study completionFeb 2014
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 WheezingStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aberdeen, University of Leicester
- Responsible party
- Principal investigator, Jonathan Grigg, Queen Mary University of London
- Investigators
- Jonathan Grigg, BSc MBBS MD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142505
- Sponsor's protocol ID
- 08/43/03
- Other IDs
- 2009-015626-11, 2009
- Acronym
- WAIT
- Status last verified
- Apr 2014
- First submitted
- 10 Jun 2010
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grigg J, Whitehouse A, Pandya H, Turner S, Griffiths CJ, Vulliamy T, T Walton R, Price DB, Sanak M, Holloway JW, Noimark L, Lesosky M, Brugha R, Koh L, Nwokoro C. Urinary prostanoids in preschool wheeze. Eur Respir J. 2017 Feb 2;49(2):1601390. doi: 10.1183/13993003.01390-2016. Print 2017 Feb. No abstract available.
PubMed 28153869Nwokoro C, Pandya H, Turner S, Eldridge S, Griffiths CJ, Vulliamy T, Price D, Sanak M, Holloway JW, Brugha R, Koh L, Dickson I, Rutterford C, Grigg J. Intermittent montelukast in children aged 10 months to 5 years with wheeze (WAIT trial): a multicentre, randomised, placebo-controlled trial. Lancet Respir Med. 2014 Oct;2(10):796-803. doi: 10.1016/S2213-2600(14)70186-9. Epub 2014 Sep 8.
PubMed 25212745
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-determined Oral Montelukast Therapy for Preschool Wheeze With Stratification for Arachidonate-5-Lipoxygenase (ALOX5) Promoter Genotype
- ClinicalTrials.gov ID
- NCT01142505
- Acronym / sponsor ID
- WAIT / 08/43/03
- Conditions
- Wheezing
- Keywords
- wheeze, preschool, leukotriene, montelukast, 5-lipoxygenase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,358 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University of Aberdeen, University of Leicester
- Study start
- Nov 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Jun 2010 (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 clinical aim of this trial is to assess whether intermittent montelukast is an effective treatment strategy in preschool wheeze. The mechanisms aim of the trial is to determine whether there is a genetically highly-responsive subgroup of children. In designing this trial the investigators have incorporated several novel aspects. First, parents will be able to adjust the use of oral montelukast to their child's symptoms. This allows the investigators to recruit both "episodic" and "multi trigger" patterns of preschool wheeze - and control for any change in wheeze pattern during the trial. Second, before the investigators issue the trial medication, the investigators will assess children's leukotriene genes, focusing primarily on a gene called ALOX5. This ALOX5 "stratification" step will ensure that an equal number of potentially "treatment-responsive" children receive the active drug (montelukast) and the dummy medicine - and the equal numbers will help the investigators to assess the role of ALOX5. For the trial, the investigators will first recruit 1,300 children with a history of preschool wheeze, then divide them into the group with "responsive" and "less responsive" genes by their ALOX5 status. The investigators will then issue parents with the trial medication; 50% will be given montelukast and 50% will be given dummy medication. Parents will start the trial medication whenever their child develops a cold, and stop the medication when wheeze resolve. Parents will also be able to give the trial medication for wheeze between colds. Over the 12 month trial period, the investigators will assess the number of unscheduled attendances to a medical practitioner for wheeze for each child. At the end of the trial, the investigators will determine whether montelukast is effective then whether there is a difference in response to montelukast between the 2 ALOX5 gene groups.
At the same time, the investigators will measure many other genes that may influence response to montelukast, as well as the amount of leukotrienes that are excreted in the urine before and during attacks. Using these results, the investigators will be able to both inform national treatment policy, and develop new concepts on the mechanism of preschool wheeze that will inform the development of new therapies. Since children will continue to receive "normal" inhaled therapy, there are no ethical issues in giving a dummy medicine to half of the 1300 children to be recruited. The study will be the largest trial in wheezy preschool children to date, and may open up genetic testing in preschool wheeze.
Detailed description
Background
A quarter of all UK children will have at least one attack of wheeze during the preschool period (1 to 5 years of age). Severe attacks of wheeze in these young children are usually triggered by viral-colds. The majority of affected children will only wheeze with colds, although these attacks may be severe and repeated resulting in GP attendances and hospital admissions. This pattern of wheeze is called "episodic" preschool wheeze. A minority of preschool children wheeze both with and between colds - a pattern that is called "multi-trigger" preschool wheeze. In real life this distinction is blurred, with preschool children changing their pattern of wheeze over time. What is clear is that asthma therapies that are effective in older children with classical "allergic" asthma may not necessarily be effective in preschool wheeze. For example, although a short-course of oral steroids is very effective in treating attacks of wheeze in school age children with "allergic" asthma, the investigators have shown in 2 major trials that a short course of oral steroids does not reduce the severity of attacks of preschool wheeze.
Recently, montelukast, an oral medicine that blocks a substance (leukotriene) that narrows the breathing tubes, has shown promise in preschool wheeze. However, to date, only modest benefits have been reported when large groups of children have been studied. One explanation for this, is that a significant proportion of preschool children do not respond to montelukast, but there is a subgroup who are genetically programmed to respond very well. Recent analysis of trials of montelukast suggests that this responsive subgroup may be defined by variations in leukotriene-producing genes. Thus an understanding of the role of leukotriene genes and leukotriene production in preschool wheeze may better target montelukast treatment in this age group, and inform the development of new therapies.
Trial Description
The clinical aim of this trial is to assess whether intermittent montelukast is an effective treatment strategy in preschool wheeze. The mechanisms aim of the trial is to determine whether there is a genetically highly-responsive subgroup of children. In designing this trial the investigators have incorporated several novel aspects. First, parents will be able to adjust the use of oral montelukast to their child's symptoms. This allows us to recruit both "episodic" and "multi trigger" patterns of preschool wheeze - and control for any change in wheeze pattern during the trial. Second, before the investigators issue the trial medication, the investigators will assess children's leukotriene genes, focusing primarily on a gene called ALOX5. This ALOX5 "stratification" step will ensure that an equal number of potentially "treatment-responsive" children receive the active drug (montelukast) and the dummy medicine - and the equal numbers will help us to assess the role of ALOX5. For the trial, the investigators will first recruit 1,300 children with a history of preschool wheeze, then divide them into the group with "responsive" and "less responsive" genes by their ALOX5 status. The investigators will then issue parents with the trial medication; 50% will be given montelukast and 50% will be given dummy medication. Parents will start the trial medication whenever their child develops a cold, and stop the medication when wheeze resolve. Parents will also be able to give the trial medication for wheeze between colds. Over the 12 month trial period, the investigators will assess the number of unscheduled attendances to a medical practitioner for wheeze for each child. At the end of the trial, the investigators will determine whether montelukast is effective then whether there is a difference in response to montelukast between the 2 ALOX5 gene groups.
At the same time, the investigators will measure many other genes that may influence response to montelukast, as well as the amount of leukotrienes that are excreted in the urine before and during attacks. Using these results, the investigators will be able to both inform national treatment policy, and develop new concepts on the mechanism of preschool wheeze that will inform the development of new therapies. Since children will continue to receive "normal" inhaled therapy, there are no ethical issues in giving a dummy medicine to half of the 1300 children to be recruited. The study will be the largest trial in wheezy preschool children to date, and may open up genetic testing in preschool wheeze.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: MannitolPatients in the placebo arm will be given an inactive version of the investigational medical product formed of the excipient mannitol (which is coated with the active drug montelukast in the active comparator arm) |
| Montelukast | Active comparator | Drug: MontelukastPatients in the active arm will be given an active version of the investigational medical product formed of the inactive excipient mannitol with a coating of active drug montelukast. |
Who may qualify
- Ages
- 10 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- age ≥ 10 months and ≤ 5 years old on the day of the first dose of Investigational Medicinal Product
- two or more attacks of parent-reported wheeze
- at least one attack with wheeze validated by a clinician
- the most recent attack within the last 3 months
- contactable by telephone and able to attend one face-to-face review for issue of Investigational Medicinal Product
Key exclusion criteria (5 listed)
- any other chronic respiratory condition diagnosed by a clinician including structural airway abnormality (e.g. floppy larynx) and cystic fibrosis
- any chronic condition that increases vulnerability to respiratory tract infection such as severe developmental delay with feeding difficulty
- history of neonatal chronic lung disease
- current continuous oral montelukast therapy
- in a trial using an Investigational Medicinal Product in the previous 3 months prior to recruitment
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 |
|---|---|---|
| MannitolAlso: Pearlitol SD 2004mg once daily granules for 10 days, given orally alone or with cold or warm food from the onset of a cold or wheezing attack. | Drug | Placebo |
| MontelukastAlso: Singulair4mg once daily granules for 10 days, given orally alone or with cold or warm food from the onset of a cold or wheezing attack | Drug | Montelukast |
Primary outcome
Need for unscheduled medical attention
Time frame: 12 months
Number of times a child attends for an unscheduled medical opinion with respiratory problems over a 12 month period, as confirmed from medical records.
7 secondary outcomes
Number of admissions to hospital
Time frame: 12 months
Duration of admissions to hospital
Time frame: 12 months
Number of unscheduled GP consultations for wheeze
Time frame: 12 months
Duration of wheezy episodes
Time frame: 12 months
Severity of episodes by diary card
Time frame: 12 months
Parent's overall impression of efficacy of Investigational Medicinal Product
Time frame: 12 months
Time to first attack of wheeze
Time frame: 12 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 29 Apr 2014.
- Derived from this study: PubMed 28153869Grigg J, Whitehouse A, Pandya H, Turner S, Griffiths CJ, Vulliamy T, T Walton R, Price DB, Sanak M, Holloway JW, Noimark L, Lesosky M, Brugha R, Koh L, Nwokoro C. Urinary prostanoids in preschool wheeze. Eur Respir J. 2017 Feb 2;49(2):1601390. doi: 10.1183/13993003.01390-2016. Print 2017 Feb. No abstract available.
- Derived from this study: PubMed 25212745Nwokoro C, Pandya H, Turner S, Eldridge S, Griffiths CJ, Vulliamy T, Price D, Sanak M, Holloway JW, Brugha R, Koh L, Dickson I, Rutterford C, Grigg J. Intermittent montelukast in children aged 10 months to 5 years with wheeze (WAIT trial): a multicentre, randomised, placebo-controlled trial. Lancet Respir Med. 2014 Oct;2(10):796-803. doi: 10.1016/S2213-2600(14)70186-9. Epub 2014 Sep 8.
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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.
Jonathan Grigg, BSc MBBS MD principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mannitol and Montelukast in people with Wheezing, run by Queen Mary University of London 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 5 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 29 Apr 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Need for unscheduled medical attention (time frame: 12 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 NCT01142505, 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 29 Apr 2014; AzTrials last refreshed its copy on 29 Oct 2026.