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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT03055793
Eligibility Criteria:
Inclusion Criteria:
* Men or women patients with asthma over 18 years
* Compliant to treatment
* Compliant to the study procedures
* Signed consent form after written study information
* Patients with Asthma to start treatment with the inhaled combination of budesonide / formoterol at doses 100 / 6mcg, 200 / 6mcg, 400/12 mcg, through Elpenhaler® device may be included in the study. Under current SPC, the drug Pulmoton® indicated in the regular treatment of asthma, wherein the administration of the combination (inhaled corticosteroid and long-action beta2-agonist) is appropriate, namely in patients:
* patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled beta2-agonists short-acting or
* already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists Note: Pulmoton® 100/6 micrograms / dose is not suitable for patients with severe asthma.
Exclusion Criteria:
* Men or women with Asthma patients under 18 years
* Non-compliance to treatment
* Non-compliance to study procedures
* Do not signed patient consent
* Incorrect use of inhaled therapies
* Patients with COPD (any stage)
* Patients already receiving any combination ICS / LABA at entry into the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03055793
Study Brief:
Protocol Section:
NCT03055793