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:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT04946318
Eligibility Criteria:
Inclusion Criteria:
* All participants must have been treated with a fixed dose combination of fluticasone propionate/salmeterol in one of two doses in stable dose alone or with additional controllers at label approved dosage (allowed only: LTRA, LAMA, Theophylline or its derivatives).
* Participants completing the Treatment period and Follow-up period of study CSJ117A12201C and continuing with study CCSJ117A12201E1 must have completed the Treatment period of CSJ117A12201C (i.e. did not discontinue blinded study treatment prematurely) and Follow-up period of study CSJ117A12201C.
Exclusion Criteria:
* Participants who were enrolled into prior study CSJ117A12201C and developed a significant and/or permanent health condition during the prior study.
* Participants who experienced a serious and drug-related AE in the prior study CSJ117A12201C.
* Participants receiving any prohibited medications.
* Participants with a history or current diagnosis of ECG abnormalities.
* Pregnant or nursing (lactating) women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04946318
Study Brief:
Protocol Section:
NCT04946318