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The purpose of this study is to compare the superiority of CHF 1535 compared to CHF 718 in subjects with asthma on medium or high dose inhaled corticosteroids.
Full description
This is a phase III, multicenter, randomized, double-blind active controlled 2-arm parallel group to compare superiority of CHF 1535 pMDI compared to CHF 718 pMDI in terms of change from baseline in FEV1 AUC0-12h at Week 12.
After screening, eligible subjects will enter a 2-week run-in period using CHF 718 (BDP) pMDI 100µg, followed by a 12-week double-blind, treatment period. Screened subjects who were on a medium dose ICS or medium dose ICS-LABA prior to the study will be put on CHF 718 pMDI 100µg 2 inhalations BID (TDD 400µg) during the 2-week run in period. Screened subjects who were on a high dose ICS prior to the study will be put on CHF 718 pMDI 100µg 4 inhalations BID (TDD 800µg) during the 2-week run in period.
Following the run-in period, eligible subjects will be randomized to one of two study drug arms (using a 1:1 allocation ratio) for 12 weeks. A total of 6 clinic visits (V0- V5) and a follow-up call (V6) will be performed during the study.
During the study, daily symptoms, rescue medication use and compliance with the study drug will be recorded via a subject electronic diary. Subject concomitant medications, and adverse events will be assessed and recorded throughout the study. At study visits, subjects will undergo vital signs, physical exam, 12-lead ECG, PEF, and spirometry measurements, including serial spirometry at V2 and V5. Symptoms will be assessed through disease specific questionnaires. Routine hematology, blood chemistry, and serum pregnancy testing will be performed before enrollment and at end of study.
Enrollment
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Inclusion criteria
Informed consent: A signed and dated written informed consent obtained prior to any study-related procedures.
Sex and age: Male or female aged ≥18 and ≤75 years.
Diagnosis of asthma: A documented history of asthma for at least 1 year, with onset before age 40
Stable asthma therapy: Use of medium-dose ICS with or without a LABA or high-dose ICS alone for 3 months (at a stable dose for at least 4 weeks prior to screening).
Lung function: Subjects with a pre-bronchodilator FEV1 ≥40% and ≤85% of predicted, after appropriate washout from bronchodilators, at the screening and randomization visits. In addition, the absolute value of the first pre-dose FEV1 at randomization (V2) must be at least 80% of the pre-bronchodilator value attained at screening.
Reversibility post-bronchodilator: Subjects with a positive reversibility to bronchodilator at screening, defined as an increase in FEV1 > 12% and > 200mL compared to baseline within 30 minutes after 4 inhalations of albuterol HFA pMDI 90µg/actuation.
Note for IC#5 and IC#6: In case the reversibility and/or quality threshold is not met at screening, the test can be performed once before randomization.
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 signing of the informed consent form and until the follow-up contact or ii. WOCBP with non-fertile male partners (contraception is not required in this case).
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 2). 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).
Cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary/peak flow meter.
Exclusion criteria
Primary purpose
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580 participants in 2 patient groups
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Chiesi Clinical Trial Info
Data sourced from clinicaltrials.gov
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