Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
FLUIDDA nv
Age
6–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and pre-menarchial female children aged 6-12yrs on visit 1. Pre-menarchial females are defined in this study as girls with breast stage 1 or 2 and no menarche.
Parents or guardian must be able to understand and complete to protocol requirements, instructions and protocol-stated restrictions. Parents/guardians must give written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Diagnosis of asthma at least 6 months previous prior to screening.
Children must be controlled on their existing asthma treatment at screening as defined by ACT or childhood ACT score of ≥ 20 and PEF\>80%.
Children must be taking a stable regime of SABA/ LABA on an as need basis, with or without Leukotriene Antagonists and inhalation corticosteroids.
All children must be competent to perform the required tests.
Children must be available to complete the study and comply with study primary objective investigations.
Children must be able to withhold from short acting bronchodilators for 6 hours.
You may not be if
As a result of the medical interview, physical examination or screening investigations, the responsible physician considers the patient unsuitable for inclusion to the study.
Children who have a past or present disease, or have had previous surgery which as judged by the Investigator, may affect patient safety or influence the outcome of the study.
The child has received an investigational drug or participated in any other research trial within 30 days, or twice the duration of the biological effect of any drug (whichever is longer).
The child has had a respiratory tract infection within two weeks of the start of the study.
Children who have had an exacerbation of disease requiring hospitalization for \> 24 hrs within four weeks prior to inclusion.
Children who are unwilling or unable to follow any of the procedures outlined in the protocol.
Child is mentally incapacitated.
Clareo Health | Modelling of the Upper Airway in Children With Controlled Asthma
