Wheeze And Intermittent Treatment; WAIT

• Research type

  Research Study

• Full title

  Parent-determined oral montelukast therapy for preschool wheeze with stratification for arachidonate-5-lipoxygenase (ALOX5) promoter genotype.

• IRAS ID

  35170

• Contact name

  Jonathan Grigg

• Sponsor organisation

  Barts and the London NHS Trust

• Eudract number

  2009-015626-11

• ISRCTN Number

  N/A

• Research summary

  A quarter of all UK children will have at least one attack of wheeze during the preschool period (10 months to 5 years 11 months of age). Severe attacks of wheeze in these young children are usually triggered by viral-colds. The aim of this trial is to assess whether the intermittent use of montelukast, a blocker of a substance that narrows the airways called leukotriene, is an effective treatment strategy in preschool wheeze. A further aim of the trial is to determine whether there is a subgroup of children that's highly responsive to montelukast due to differences in their genetic ability to produce leukotriene. The gene that we will focus on is ??ALOX5? since there is evidence that variations in ALOX5 alter montelukast responsiveness in adult asthmatics. Parents will start the trial medication (either active or inactive granules given once a day) whenever their child develops a cold, and stop the medication when their child's wheeze resolves. Parents will also give the trial medication for wheeze between colds. For each family the trial will last 12 months, and during this period children will continue to receive standard inhaled therapy. During this period we will assess the number of unscheduled attendances to a medical practitioner for wheeze. At the end of the trial, we will determine whether montelukast is effective and whether there is a difference in response to montelukast between the children with a particular variant of the ALOX5 gene. We will also assess whether responsiveness to montelukast is affected by other genes and their relationship between genes and the amount of leukotrienes excreted in the urine.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/110

• Date of REC Opinion

  23 Nov 2009

• REC opinion

  Favourable Opinion