A research study to compare two formulations of beclometasone/formoterol pMDI on respiratory system.

Phase 1

• Conditions: Persistent asthma; MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-000353-50-GB
• Lead Sponsor: CHIESI FARMACEUTICI S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-26
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 24

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br> ;<br> 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.<br> •To evaluate the effect of two formulations of CHF 1535 100/6 µg pMDI on pre- and post-challenge impulse oscillometry and PK profile.<br> ;Primary end point(s): Average AX over 60 minutes profile ;<br> 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)<br>