Extrait

Background and study aims Wheezing is a whistling sound caused by breathing through narrowed airways. It is a common problem in young children. Many preschool children have repeated wheezy episodes, and share characteristics with older children who have asthma. Like them, they are often treated with inhaled salbutamol. However, in the preschool years it is difficult to make a definite diagnosis of asthma, and there is much less consensus about treatment. The correct dose of inhaled salbutamol has been determined in adults and older children by studying their response to a range of doses. This has not been possible in children below 7 years of age who are unable to cooperate with the tests. Doctors commonly ask parents to use any dose between 200 to 1000 micrograms of salbutamol to help their child's wheezy spells. Recently, however, a lung function test that could be used for this purpose has been validated in young children. This study proposes to use this test (Rint) to find the correct dose range that produces an adequate response in most young children. Recent work also suggests that even large doses of salbutamol may not be effective in relieving symptoms in some children. We will define the extent of this problem, as there are alternative 'relievers' that could then be used to help these children. We will also explore whether a simple genetic test that could predict this lack of response. Who can participate? Children aged 2 years 6 months to 6 years 11 months, with recurrent wheeze (at least 3 episodes of wheezing over the previous 12 months) What does the study involve? Participants are randomly allocated to inhale one of four different doses of salbutamol. Lung function is tested before and 20 minutes after inhaling salbutamol. Saliva and urine samples are also collected. The one-off study visit lasts for around two and half hours and there is no follow up. What are the possible benefits and risks of participating? Involvement in the study and the resulting discussions may provide the parent/carer and child with a greater understanding of the processes causing wheeze. This study does not have any risk of physical or psychological harm, and there are no painful procedures. Some young children are bothered by the clicking sounds during the breathing test, so we spend a little time beforehand getting them used to the equipment. The researchers work with the parents to distract them during the measurements. The collection of the urine and saliva samples does not involve any risks to the child. Travel expenses to the hospital (up to £20) for the research study visit can be reimbursed. Where is the study run from? Royal Sussex County Hospital (UK) When is the study starting and how long is it expected to run for? January 2014 to June 2017 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Gemma Earl

Critère d'inclusion

• Topic: Children; Subtopic: All Diagnoses; Disease: All Diseases

Liens

• isrctn
• ictrp