Study in Adult Patients With Moderate to Severe Asthma (FEEL)

Chiesi

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Behavioral: Exploratory study on patient's perception of Asthma symptoms

Study type: Interventional

Funder types: Industry

Identifiers

NCT04886999

CLI-01535AA0-02

2021-001449-11 (EudraCT Number)

Details and patient eligibility

About

The CLI-01535AA02-2 Study is an exploratory study designed to compare two pressurised metered Dose inhalers on subject's perception of asthma symptoms.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups

Inhaler A CHF1535 100/6 µg pMDI

Experimental group

Description:

Active ingredient: Fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg. Excipients: HFA-134a, Ethanol anhydrous, Hydrochloric acid. Presentation: Canister containing 120 doses plus actuator.

Treatment:

Behavioral: Exploratory study on patient's perception of Asthma symptoms

Inhaler B CHF1535 100/6 µg pMDI

Active Comparator group

Description:

Active ingredient: Fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg. Excipients: HFA-134a, Ethanol anhydrous, Hydrochloric acid. Presentation: Canister containing 120 doses plus actuator

Treatment:

Behavioral: Exploratory study on patient's perception of Asthma symptoms