Clinical trial NCT04886999: Study in Adult Patients With Moderate to Severe Asthma
Official title: An Exploratory, Double-blind, Randomised, Multicenter, Psychopharmacological Study in Adult Patients With Moderate to Severe Asthma to Compare Two Pressurised Metered-Dose Inhalers (pMDIs) on Patients' Perception of Asthma Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2021-05-14
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Exploratory, double-blind, randomised, multicenter, 2x2 cross-over study
Primary purpose: OTHER

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 last approximately 6 weeks for each subject.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Summary measures (for questions with continuous outcome) to report patients' expectations of their symptoms change at Day 15 (Visit 2)
timeFrame: At Day 15 (Visit 2)
measure: Summary measures (for questions with continuous outcome) to report patients' expectations of their symptoms change at Day 29 (Visit 3)
timeFrame: At Day 29 (Visit 3)
measure: Summary measures (for questions with continuous outcome) to report patients' expectations of their symptoms change at Day 43 (Visit 4)
timeFrame: At Day 43 (Visit 4)
measure: Percentages of subjects (for questions with categorical outcome) to evaluate patients' preference of device at Day 43 (Visit 4)
timeFrame: At Day 43 (Visit 4)
measure: Percentages of subjects (for questions with categorical outcome) to evaluate patients' perception of inhalers changes at Day 43 (Visit 4)
timeFrame: At Day 43 (Visit 4)
measure: Change from baseline in average Visual Analogic Scale score of subjects' perceptions of asthma symptoms after 14 days of treatment
timeFrame: After 14 days of treatment
measure: Change from baseline in average Visual Analogic Scale score of subjects' perceptions of asthma symptoms after the first 7 days of treatment
timeFrame: After the first 7 days of treatment
measure: Change from baseline in rescue medication use
timeFrame: After 14 days of treatment
measure: Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) score
timeFrame: After 14 days of treatment
Secondary outcomes:
measure: Occurrence of Treatment Emergent Adverse Event (TEAEs), adverse drug reactions (ADRs), severe ADRs, serious ADRs, serious TEAEs (Serious Adverse Events), non-serious TEAEs, severe TEAEs
timeFrame: From date of the first study drug intake unil date of study treatment, or date of death or up to 14 days after date of the last study drug intake, whichever came first
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Chiesi 38011
city: Battipaglia
country: Italy
facility: Chiesi 38009
city: Cagliari
country: Italy
facility: Chiesi 38006
city: Catanzaro
country: Italy
facility: Chiesi 38010
city: Genova
country: Italy
facility: Chiesi 38003
city: Milan
country: Italy
facility: Chiesi 38001
city: Napoli
country: Italy
facility: Chiesi 38005
city: Palermo
country: Italy
facility: Chiesi 38004
city: Roma
country: Italy
facility: Chiesi 38002
city: Sassari
country: Italy
facility: Chiesi 38007
Study officials:
affiliation: Chiesi Farmaceutici S.p.A.
name: Eva Topole, MD
role: STUDY_DIRECTOR
References: