Study in Adult Patients With Moderate to Severe Asthma
Study Identifier:
CLI-01535AA0-02
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Trial Documents
Protocol
Available Languages: English
Statistical Analysis Plan
Available Languages: English
Plain Language Summary
Available Languages: English, Italian
Study Details
Medical Condition
- Asthma
Study Drug
- Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A)
- Drug: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)
Date
Feb 2022 - Feb 2023
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Inclusion and Exclusion 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 and autoimmune disorders
- Alcohol/drug abuse
- Participation in an investigational trial within the last 30 days (60 days for biologics) or a more appropriate time as determined by the Investigator
- Contra-indications to Foster® constituted an exclusion criterion
- History of hypersensitivity to Foster® or any of its components or a history of any other allergy that in the opinion of the Investigator contra-indicated the subject's participation
- Subject mentally or legally incapacitated or subject accommodated in an establishment as a result of an official or judicial order
- Blind, colour-blind subject or any other dyschromatopsia
- Known psychiatric disorders that may have interfered with successful completion of this protocol according to the Investigator's judgment including schizophrenia, bipolar disorders and psychoses.
Healthy Volunteers
No
Protocol Summary
This study assessed the influence of pink vs. white pressurized metered-dose inhaler (pMDI) actuators on asthma symptoms perception. There was no prespecified primary objective. The following objectives were assessed:
- Change from baseline in average visual analog scale (VAS) score of the perception of asthma symptoms and burden over the first 7 days and all 14 days in each treatment period (Questions 3-6);
- Change from baseline in AQLQ score after 14 days of treatment in each period;
- Summary measures of psychopharmacological aspects (Questions 7-10);
- Patients' preference and perception of the devices (Questions 11-16);
- Change from baseline in reliever medication use over 14 days of treatment in each period (Question 2).
For both treatment periods, "baseline" for the questionnaire data was the 14-day period prior to the first treatment period, and for AQLQ was the value recorded at Visit 2.
Study Locations
Location
Status
Location
Chiesi Clinical Trial Site 38011
Bari, Italy
Status
N/A
Location
Chiesi Clinical Trial Site 38009
Battipaglia, Italy
Status
N/A
Location
Chiesi Clinical Trial Site 38006
Cagliari, Italy
Status
N/A
Location
Chiesi Clinical Trial Site 38010
Catanzaro, Italy
Status
N/A
Location
Chiesi Clinical Trial Site 38003
Genova, Italy
Status
N/A
Location
Chiesi Clinical Trial Site 38001
Milan, Italy
Status
N/A
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