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 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT00385593
Eligibility Criteria:
Inclusion Criteria:
* Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).
* Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
* Either daily maintenance treatment with both inhaled GCS and LABA or daily treatment with inhaled GCS alone (i.e. without LABA)
* A history of suboptimal asthma control the month prior to enrolment as judged by the investigator
* Use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment
Exclusion Criteria:
* Previous treatment with Symbicort Single Inhaler;
* Use of any b-blocking agent, including eye-drops and oral GCS as maintenance treatment.
* Known or suspected hypersensitivity to study therapy or excipients.
* A history of smoking ≥ 10 pack years.
* Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00385593
Study Brief:
Protocol Section:
NCT00385593