Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT01594151
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT01594151
Study Brief:
Protocol Section:
NCT01594151