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:
NCT01156818
Eligibility Criteria:
Inclusion Criteria:
* Physician diagnosed asthma.
* Poorly controlled asthma as per GINA Guidelines with frequent (i.e. \>5/week) use of reliever medications.
* Adequate comprehension level and demonstrated ability to perform unsupervised spirometry, wheezometry and use the symptom diary.
* Age range 8-80. Patients over 40 will only be included if they are lifetime non-smokers, who have demonstrated reversibility of airway obstruction (at least 12% improvement in FEV1.0 after bronchodilator).
* All patients included in the study will be routinely receiving either a short acting bronchodilator or a long acting bronchodilator twice daily as part of their regular medication. Additional doses of bronchodilator will be taken on an as needed basis. No change in regular medication will be made for the purposes of the study.
* Subject or subject's parents/guardians is/are able to comprehend and give informed consent for participation in the study.
Consent of treating physician.
Exclusion Criteria:
* Inability to perform spirometry and/or Wheezometry. Skin Disorder (burn, infection, or allergy) over upper chest (Child) or neck (Adult).
* Patients with other diseases, which in the opinion of the treating physician would interfere with the management of asthma and performance of the study according to the protocol.
* Hospitalization at recruitment, \[patients who get admitted while participating will continue to participate\].
P- hysician objection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
80 Years
Study:
NCT01156818
Study Brief:
Protocol Section:
NCT01156818