Status:
COMPLETED
Study in Adult Patients With Moderate to Severe Asthma
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The CLI-01535AA02-2 Study is an exploratory study designed to compare two pressurised metered Dose inhalers on subject's perception of asthma symptoms.
Detailed Description
Outpatients attending the hospital clinics/study centers will be recruited. Moderate to severe asthma adult subjects will be recruited. A total of 75 subjects will be enrolled. The whole study will la...
Eligibility Criteria
Inclusion
- Subject's and/or subject legal representative's written informed consent obtained prior to any study related procedure.
- Age: ≥18 and ≤75 years of age.
- Established diagnosis of permanent asthma for at least 6 months prior to screening/randomisation visit
- Subject on maintenance therapy treated by Foster® (CHF1535 100/6 µg pMDI) for at least 6 months prior to screening/randomisation visit
- Asthma Control Test (ACT) ≥ 20 at screening/randomisation visit.
- Subject must have a cooperative attitude and the ability to be trained to use correctly the diary and answer the Visual Analogue Scale (VAS)
- Subject willing and able to download the application on their personal electronic device to fill in the study e-diary.
- Female subject of non-childbearing potential defined as physiologically incapable of becoming pregnant or female subject + male Partner must be willing to use a highly effective birth control method from the signature of the informed consent and until Visit 4
Exclusion
- Pregnant or lactating woman
- History of 'at risk' asthma
- Recent exacerbation
- Non-permanent asthma
- Asthma requiring more than 1 inhaler for maintenance treatment and more than 1 inhaler for reliever treatment.
- Asthma requiring use of biologics
- Respiratory disorders
- Lower tract respiratory infection
- Current smoker or ex-smoker with a smoking current use/history of ≥ 10 pack-years
- Cardiovascular diseases
- subject with historical or current evidence of uncontrolled concurrent disease such as but not limited to hyperthyroidism, diabetes mellitus or other endocrine disease; haematological disease; autoimmune disorders
- Alcohol/drug abuse
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04886999
Start Date
February 24 2022
End Date
February 1 2023
Last Update
February 20 2024
Active Locations (10)
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1
Chiesi 38011
Bari, Italy
2
Chiesi 38009
Battipaglia, Italy
3
Chiesi 38006
Cagliari, Italy
4
Chiesi 38010
Catanzaro, Italy