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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT01386151
Eligibility Criteria:
Inclusion Criteria:
* Age 18 - 60 years, either gender
* Confirmed diagnosis of asthma for \> 1 year as defined by BTS guidelines, requiring treatment with high dose inhaled corticosteroids +/- long acting β2 agonists, with persisting symptoms requiring use of short-acting beta agonist therapy \>3x/week.
* Never-smoker or ex-smoker, having stopped \>1 year ago, with \<10 pack year history.
* Subject must understand the procedures of the study and agree to participation in the study by providing written informed consent
* Subject considered fit enough to undergo lung function testing including provocation tests, and bronchoscopy.
* Subject must not be participating in another clinical trial or have done so within the last 12 weeks.
Exclusion Criteria:
* Patients requiring regular maintenance oral steroids for their asthma, or those who are adhering to symbicort SMART single inhaler regime.
* Pregnancy (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test \>5mIU/ml), an intention to become pregnant or breast-feeding (lactating).
* Subjects with active lung disease other than asthma
* Significant medical (cardiopulmonary, neurological, renal, endocrine, gastrointestinal, psychiatric, hepatic or haematological)co-morbidity which in the view of the investigator could impact on the interpretation of results or participation in the trial, or which is uncontrolled with standard treatment.
* Current participation in another clinical trial or previous participation within the last 12 weeks.
* Alcohol or active drug abuse.
* Ongoing allergen desensitisation therapy
* Regular use of sedatives, hypnotics, tranquilisers
* Cancer or previous history of cancer
* Inability to understand directions for dosing and study assessment.
* Inability to be contacted in case of emergency.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01386151
Study Brief:
Protocol Section:
NCT01386151