uncontrolled asthma MedDRA version: 16.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: CHF 5259 pMDI
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: GLYCOPYRRONIUM BROMIDE
CAS Number: 596-51-0
Concentration unit: µg microgram(s)
Concentration typ
Sponsors
CHIESI FARMACEUTICI S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient’s written informed consent obtained prior to any study-related procedures. 2.Male or female patients aged =18. 3.Patients with uncontrolled asthma on medium doses of ICS+LABA (>500-1000 µg daily dose BDP non-extrafine or equivalent plus formoterol 24 µg or salmeterol 100 µg) at a stable dose for at least 4 weeks prior to screening. Drug* Medium daily dose BDP non-extrafine >500-1000 µg BDP extrafine >250-500 µg Budesonide >400-800 µg Ciclesonide >160-320 µg Fluticasone >250-500 µg Mometasone =400 µg-=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1.Inability to carry out pulmonary lung function testing, to comply with study procedures or with study treatment intake. 2.History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit or of frequent exacerbations which, in the judgement of the investigator, may place the patient at undue risk. 3.Hospitalisation, emergency room admission or use of systemic corticosteroids for asthma exacerbation in the 4 weeks prior to screening visit and during the run-in period. 4.Lower respiratory tract infection in the 4 weeks before the screening visit or during the run-in period. 5.Patients who are in therapy for gastroesophageal reflux disease (GERD) and/or patients with a medical history of GERD that leads to asthma symptoms. 6.Patients with a seasonal worsening of asthma and who cannot complete the study outside the relevant allergen season. 7.History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with data evaluation. 8.Patients who suffer from COPD as defined by the current GOLD guidelines. 9.Current smokers or ex-smokers with total cumulative exposure equal or more than 10 pack-years and /or having stopped smoking one year or less prior to screening visit. 10.Any change in dose, schedule, formulation of ICS + LABAs in the 4 weeks prior to screening visit. 11.Patients used to be or being treated with inhaled long-acting antimuscarinic drugs. 12.Patients being treated with anti-IgE antibodies 13.Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are using one or more reliable methods of contraception 14.Patients who have received an investigational drug within 2 months before screening visit. 15.Patients who have clinically significant cardiovascular condition according to investigator’s judgement 16.An abnormal and clinically significant 12-lead ECG that results in active medical problem which may impact the safety of the patient according to investigator’s judgement. 17.Patients whose electrocardiogram (12-lead ECG) shows QTcF >450 ms for males or QTcF >470 ms for females at screening or at randomisation visits. 18.Medical diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator, would prevent use of anticholinergic agents. 19.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration and, in the judgment of the investigator, would make the patient inappropriate for entry into this study, place the patients at undue risk or potentially compromise the results or interpretation of the study. 20.Patients having received a live-attenuated virus vaccination within two weeks prior to screening or during the run-in (inactivated influenza vaccination is acceptable provided it is not administered less than 48 hours prior to screening). 21.Patients mentally or legally incapacitated. 22.Patients with a history of alcohol or drug abuse. 23.Patients with known intolerance/hypersensitivity or contra-indication to treatment with ß2-agonists, inhaled corticosteroids, anti-cholinergics or propellant gases/excipients. 24.Patients with major surgery in the 3 months prior to screening visit and/or planned surgery during the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a free combination of CHF 5259 (glycopyrrolate bromide [GB]) at 3 dose levels plus Foster 100/6 µg (fixed combination of beclomethasone dipropionate [BDP] plus formoterol [FF]) in a metered dose inhaler by comparison with Foster 100/6 µg in terms of FEV1 AUC0-12h normalised by time on Day 42.;Secondary Objective: Key secondary objective To evaluate the efficacy of the free combination CHF 5259 plus Foster 100/6 µg by comparison with Foster 100/6 µg in terms of Peak FEV1 on Day 42. Secondary objectives To evaluate the effect of the free combination of CHF 5259 plus Foster 100/6 µg on other lung function parameters and on clinical outcome measures. To assess the safety and the tolerability of the study treatments ;Primary end point(s): FEV1 AUC0-12h normalised by time (FEV1 AUC0-12h absolute value / 12 hours);Timepoint(s) of evaluation of this end point: Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from Baseline in Peak FEV1 Safety (Adverse Events and Adverse Drug Reactions) ;Timepoint(s) of evaluation of this end point: Day 42 for peak FEV1 and across the study for the safety | — |
Countries
Bulgaria, Germany, Hungary, Italy, Poland, United Kingdom
Contacts
Public ContactClinical Study Manager
CHIESI FARMACEUTICI S.p.A
Outcome results
None listed