Study in Adult Patients With Moderate to Severe Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2023-02-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Exploratory, double-blind, randomised, multicenter, 2x2 cross-over study

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Exploratory, double-blind, randomised, multicenter, 2x2 cross-over study

Study Groups

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Inhaler A CHF1535 100/6 µg pMDI

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.

Group Type EXPERIMENTAL

Exploratory study on patient's perception of Asthma symptoms

Intervention Type BEHAVIORAL

To assess the perception of symptoms and the psychopharmacological aspects in patients with moderate to severe asthma comparing two inhalers of CHF1535 100/6 µg pMDI

Inhaler B CHF1535 100/6 µg pMDI

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

Group Type ACTIVE_COMPARATOR

Exploratory study on patient's perception of Asthma symptoms

Intervention Type BEHAVIORAL

To assess the perception of symptoms and the psychopharmacological aspects in patients with moderate to severe asthma comparing two inhalers of CHF1535 100/6 µg pMDI

Interventions

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Exploratory study on patient's perception of Asthma symptoms

To assess the perception of symptoms and the psychopharmacological aspects in patients with moderate to severe asthma comparing two inhalers of CHF1535 100/6 µg pMDI

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No