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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT00476268
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of moderate to severe persistent asthma (according to GINA 2002 guidelines)
* FEV1 \> 40% and \< 80% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
* Patients already treated for at least 2 months with an association of inhaled corticosteroids plus LABA at doses of:
750 - 1000 µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs)
* Or patients naïve of LABA already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of SABA and/or with clinical symptoms \> 3 times in the week prior to inclusion
* A documented positive response to the reversibility test.
Exclusion Criteria:
* Pregnant or lactating females or women of childbearing potential without any efficient contraception.
* Heavy smokers defined as smoking for \> 10 pack years.
* Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids).
* Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer.
* Clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities.
* Patients with an abnormal QTc interval value in the ECG test, defined as \> 450 msec in males or \> 470 msec in females.
* Evidence of asthma worsening during the week preceding randomisation (e.g. PEF variability \> 30% during 2 consecutive days, SABA use \> 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00476268
Study Brief:
Protocol Section:
NCT00476268