Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Hospital, Antwerp
With
Chiesi Farmaceutici S.p.A.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients with moderate asthma as defined by the current GINA guidelines. Patients can belong to 2 categories:
Group 1 (n=15 to 20, at least 4 current smokers): Patients not well controlled (partially controlled or uncontrolled according to the GINA guidelines) when using medium daily dose of ICS or medium dose ICS + long acting inhaled 2-agonists (LABA) (for definition please refer to the addendum in section 15) given for at least 6 weeks as large-particle formulation (non extra-fine).
Group 2 (n=15 to 20, at least 4 current smokers ): Patients well controlled (according to GINA guidelines) when using medium daily dose of ICS + LABA (for definition please refer to the addendum in section 15) given for at least 6 weeks as large-particle formulation (non extra-fine).
2. Male or female patients aged ≥18 years
3. Patients with a documented diagnosis of asthma according to the GINA guidelines
4. Patients with a co-operative attitude and ability to be trained to correctly use the Foster NEXThaler DPI
5. Written informed consent obtained
You may not be if
1. Patients treated with extra-fine ICS either alone or with LABA
2. Pregnant or lactating females or females at risk of pregnancy at screening and not willing to use an appropriate contraception method during the study period
3. Inability to carry out pulmonary function testing
4. History of near fatal asthma
5. Hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks
6. Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
7. Cancer
8. Current alcohol or drug abuse
9. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
10. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
11. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
12. Patients treated with any non-permitted concomitant medication
Clareo Health | Study to Assess the Effect of the NEXThaler® Device (DPI - Dry Powder Inhaler) on the Central and Peripheral Airway Dimensions in Asthmatic Patients
