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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT00220259
Eligibility Criteria:
Inclusion Criteria:
.Diagnosis of CF (positive sweat test or DNA analysis). .Age over 6.0 years (no upper limit). .FEV1 \> 40% predicted for gender, height and age. .Already taking ICS for at least 3 months. .Patients who are able to perform spirometry and can correctly use their prescribed inhaler.
.Patients whose parents or legal guardians are willing to give written informed consent for their child to participate in the study. The investigators will also obtain consent from the child whenever possible.
.Patients who are likely to cooperate with taking the study medication and attend the clinic at appointed times.
Exclusion Criteria:
* Taking oral corticosteroids, usually for allergic bronchopulmonary aspergillosis (ABPA), currently or within the previous month.
* Cases in which the clinician feels unhappy about stopping ICS due to severe lung disease or concomitant "asthma" (see below).
* Course of intravenous antibiotics (IVABs) within last month.
* Taking part in another drug trial within last 2 months. .Use of high doses of inhaled corticosteroids (greater than or equal to 2000mcg/d fluticasone for 17 years or over and greater than or equal to 1000mcg/d fluticasone if less than 17 years.
* Patients with any medical or psychological condition, which in the opinion of the investigators precludes their entry into the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT00220259
Study Brief:
Protocol Section:
NCT00220259