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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT01377792
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of Cystic fibrosis
* Over 6 years old
* FEV1 over than 30%
* Must be able to perform a spirometry
* Must be able to perform induced sputum
* Must tolerate the maximum dose of 10 ml hypertonic saline
* No oral neither intravenous treatment within the previous 2 weeks before the beginning of the study
* No treatment with hypertonic saline in the 2 weeks before
Exclusion Criteria:
* No clinical diagnosis of Cystic Fibrosis
* No tolerance of 10 ml of hypertonic saline
* Positive pregnancy test
* No tolerance of Beta2-agonist
* Treatment with corticosteroids
* FEV1 \< 30%
* Liver and/or lung transplantation
* Oxygen treatment
* Hospital admission within the 4 previous weeks
* Oral or intravenous antibiotic treatment within the 2 previous weeks
* Smokers
* Pulmonary colonisation with Burkholderia cepacia complex
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT01377792
Study Brief:
Protocol Section:
NCT01377792