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Sponsor: Chiesi Farmaceutici S.p.A.
Conditions: Asthma
Interventions: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A), Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)
Countries: Italy
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.
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Bari, Italy
- Battipaglia, Italy
- Cagliari, Italy
- Catanzaro, Italy
- Genova, Italy
- Milan, Italy
- Naples, Italy
- Palermo, Italy
- Roma, Italy
- Sassari, Italy