Study with adult asthmatic patients to understand how asthma symptoms are perceived by comparing two inhalers.
- Conditions
- Moderate to severe asthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-001449-11-IT
- Lead Sponsor
- CHIESI FARMACEUTICI S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 75
1.Subject’s and/or subject legal representative’s written informed consent obtained prior to any study related procedure.
2.Age: >=18 and <=75 years of age.
3.Diagnosis of asthma: Established diagnosis of permanent asthma for at least 6 months prior to screening/randomisation visit, with documented history of variable respiratory symptoms and confirmed variable expiratory airflow limitation according to the description in the Box 1-2 of the 2020 GINA Report.
4.Current asthma therapy: Subject on maintenance therapy treated by Foster® (CHF1535 100/6 µg pMDI) for at least 6 months prior to screening/randomisation visit (A subject under Foster® MART indication is eligible).
5.Asthma control: Asthma Control Test (ACT) >= 20 at screening/randomisation visit.
6.Ability to comply with the protocol: Subject must have a cooperative attitude and the ability to be trained to use correctly the diary and answer the Visual Analogue Scale (VAS), to be able to perform the required outcomes measurements and the ability to understand the risks involved.
7.Subject willing and able to use their electronic device to download the application to fill in the study e-diary and to enable video communication.
8.Female subjects:
a.WOCBP fulfilling one of the following criteria:
i.WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until Visit 4 or
ii.WOCBP with non-fertile male partners (contraception is not required in this case).
For the definition of WOCBP and of fertile men and the list of highly effective birth control methods, refer to Appendix 4.
or
b.Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile, as per definitions given in Appendix 4). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator’s request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1. Pregnant or lactacting woman
2. History of 'at risk' asthma: history of near fatal asthma, hospitalisation for asthma in intensive care unit which in the judgement of the investigator may place the subject at undue risk
3. Recent exacerbation: asthma exacerbation requiring systemic corticosteroids or emergency room admission or hospitalization within 4 weeks prior to screening/randomization visit
4. Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine.
5. Asthma requiring more than 1 inhaler for manteinance treatment and than more 1 inhaler for reliever treatment
6. Asthma requiring use of biologics: asthma subject treated with chronic systemic corticosteroids or anti-IgE or other monoclonal or polyclonal antibodies.
7. Respiratory disorders rather than asthma
8. Subject with lower respiratory tract infection that required use of antibiotics within 4-6 weeks prior to screening/randomization
9. Current smoker or ex-smoker with a smoking current use/history of >= 10 pack-years
10. Cardiovascular disease
11. Other concurrent disease
12. Subject with a known or suspected history of alcohol and/or substance drug abuse within 12 months prior to screening/randomisation visit
13. Subject who has received any investigational drug within the last 30 days (60 days for biologics) or a more appropriate time as determinated by the investigator
14. Contra-indications to Foster®
15. History of hypersensitivity to Foster® or any of its components or a history of other allergy that in the opinion of the investigator controindicates the subject's participation
16. Subject mentally or legally incapacitated
17. Blind, colour blind subject or any other dyschromatopsia
18. Known psychiatric disorders that may interfere with successful completion of this protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the perception of symptoms and the psychopharmacological aspects in moderate to severe asthma subjects comparing two inhalers of CHF1535 100/6 µg pMDI.;Secondary Objective: NA;Primary end point(s): 1. Percentages of subjects (for questions with categorical outcome) or summary measures (for questions with continuous outcome) to questions covering subjects’ preference of device and outcome assessments;;Timepoint(s) of evaluation of this end point: Day 43 (Visit 4)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline in reliever medication use after 14 days of treatment; Change from baseline in AQLQ score after 14 days of treatment; Adverse Events and Serious Adverse Events; Change from baseline in average VAS score evaluating subject perceptions of asthma symptoms after 7 days and 14 days of treatment;;Timepoint(s) of evaluation of this end point: After 14 days of treatment; After 14 days of treatment; Study duration; After 7 days and 14 days of treatment