Persistent asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: CHF 1353 100/6 (AP) pMDI (Alternative Product)
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
Sponsors
CHIESI FARMACEUTICI S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients aged 18 years and above. - Patient’s written informed consent obtained prior to any study related procedures. - Patients with established diagnosis of persistent asthma for at least 6 months according to international guidelines. - Patients on 400-2000µg BDP equivalent of Inhaled Corticosteroids (ICS) per day +/- 2nd/3rd line therapy. - Patients with Forced Expiratory Volume in 1 second (FEV1) = 60% predicted at screening. - Patients with methacholine PC40 R5 = 8mg/ml at screening. - Non- or ex-smokers who smoked = 5 Pack-years and quitted smoking > 1 year prior to screening - Female patients must be either of non-childbearing potential or childbearing potential fulfilling one of the following criteria: o 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 the follow-up contact or o with non-fertile male partners (contraception is not required in this case). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: - Patients with any other respiratory diseases such as Chronic Obstructive Pulmonary Disease, bronchiectasis or Allergic Bronchopulmonary Aspergillosis, which in the opinion of the investigator are considered to be clinically significant and may have an impact on the study outcomes. - Patients with an asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement or 3 months if hospital admission was required or during the run-in period. - Exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine. - Patients with any known systemic clinically significant medical condition, and communicable disease that may endanger the health or safety of the patients. - Female patients who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to evaluate the effect of two formulations of CHF 1535 100/6 µg pMDI on AX (Area under the curve of Reactance) 0-60 minutes post IMP administration in asthmatic patients. ; Secondary Objective: • To evaluate the effect of two formulations of CHF 1535 100/6 µg pMDI on airway hyperresponsiveness (as methacholine PC40 R5) and reactivity (as Response Dose Ratio, RDR) in asthmatic patients. • To evaluate the effect of two formulations of CHF 1535 100/6 µg pMDI on pre- and post-challenge impulse oscillometry and PK profile. ;Primary end point(s): Average AX over 60 minutes profile ; Timepoint(s) of evaluation of this end point: AX post chronic IMP administration (V2 and V4) measured over 60 minutes vs AX baseline before the first IMP administration (V1 and V3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: • R20, R5-R20, R5, Respiratory System Reactance at 5 Hertz (X5) and Resonance Frequency (RF) post chronic IMP administration (V2 and V4) measured over 60 minutes vs R20, R5-R20, R5, X5 and RF baseline before the first IMP administration (V1 and V3) • AX, R20, R5-R20, R5, X5 and RF IOS pre-IMP at V2/V4 versus IOS baseline (pre-IMP) at V1/V3; • at V2/V4 IOS profile post IMP versus IOS pre-IMP; • PC40 R5 and RDR (Response dose ratio) during methacholine challenge at V2/V4 ; Secondary end point(s): • R20, R5-R20, R5, X5 and RF post chronic IMP administration (V2 and V4)over 60 minutes profile • AX, R20, R5-R20, R5, X5 and RF IOS pre-IMP at V2/V4, using IOS baseline parameters at V1/V3 as covariates • Average AX over 60 minutes profile with IOS pre-IMP (collected at V2/V4) instead of IOS baseline (collected at V1/V3) as covariate • PC40 R5 during methacholine challenge at V2/V4 • RDR (Response dose ratio) | — |
Countries
United Kingdom
Contacts
Public ContactClin Project Manager Hélène Prunier
CHIESI FARMACEUTICI S.p.A
Outcome results
None listed