A research study to evaluate the effect of a new medicine (glycopyrrolate) administered on top of a licensed medicine (Qvar) in patients with uncontrolled asthma
- Conditions
- uncontrolled asthmaMedDRA version: 17.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-001442-16-DE
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Patient’s written informed consent obtained prior to any study-related procedures
2. Male or female patients aged =18 and =75 years.
3. History of asthma = 5-year and diagnosed before the age of 40 years.
4. Patients with uncontrolled asthma on low-medium doses of Inhaled Corticosteroid (ICS) (200 – 1000 µg daily dose BDP non-extrafine or estimated clinical comparable dose) at a stable dose for at least 4 weeks prior to screening.
5. Patients with a pre-bronchodilator FEV1 =40% and <90% of their predicted normal value, after appropriate washout from bronchodilators, at screening and at the end of the run-in period.
6. Patients with a positive response to the reversibility test at screening within 30 minutes after administration of 400 µg of salbutamol pMDI, defined as ?FEV1 = 12% and = 200mL over baseline.
7. Patients with uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire© (ACQ) =1.5 (criterion must be met at screening and at the end of the run-in period).
8. Patients with a co-operative attitude and ability to be trained to correctly use the pMDI and the electronic peakflow meter.
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
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 in the last year which may place the patient at risk.
3. Hospitalisation, emergency room admission or use of systemic corticosteroids for asthma exacerbation in the 4 weeks prior to screening visit or 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 current therapy for gastroesophageal reflux disease (GERD) 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, bronco-carcinoma, lung carcinoma or any other significant lung disease which may interfere with data evaluation.
8. Patients with a medical history or current diagnosis of COPD as defined by the GOLD guidelines (2014).
9. Current smokers or ex-smokers with total cumulative exposure equal or more than 10 pack-years or having stopped smoking one year or less prior to screening visit.
10. Any change in dose, schedule or formulation of ICS in the 4 weeks prior to screening visit.
11. Patient had used any of the following treatments 4 weeks before screening visit: inhaled long-acting ß2-agonists (LABAs), inhaled long acting muscarinic antagonists (LAMAs), inhaled ICS/LABA fixed combinations, theophylline, leukotriene modifiers, cromolyn sodium, nedocromil sodium, systemic anticholinergics, systemic corticosteroids (12 weeks for slow release corticosteroids).
12. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are using at least one or more reliable methods of contraception.
13. Patients who received any investigational new drug or participated in clinical study either within the last 8 weeks (or 5 half-lives for biologic products with slow elimination) before screening.
14. Patients who have clinically significant cardiovascular condition according to investigator’s judgement
15. 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
16. Patients whose electrocardiogram (12-lead ECG) shows QTcF >450 ms for males or QTcF >470 ms for females at screening or at randomisation visits.
17. 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.
18. Unstable concurrent disease
19. Patients having received a live-attenuated virus vaccination within
two weeks prior to screening or during the run-in phase
20. Patients mentally or legally incapacitated.
21. Patients with a history of alcohol or drug abuse.
22. Patients with known intolerance/hypersensitivity or contra-indication to treatment with ß2-agonists, inhaled corticosteroids, anti-cholinergics or propellant gases/excipients.
23. Patients with major surgery in the 3 months prior to screening visit or planned surgery during the trial.
24. Patients being treated with anti-IgE antibodies.
25. Patients treated wit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the superiority of CHF 5259 pMDI (glycopyrrolate bromide) (50 µg total daily dose) versus placebo in terms of FEV1 AUC0-12h normalised by time on Day 42.<br>;Secondary Objective: Key Secondary objective<br>To evaluate the superiority of CHF 5259 pMDI (50 µg total daily dose) versus placebo in terms of peak FEV1 on Day 42.<br><br>Secondary objectives<br>? To evaluate the effect of CHF 5259 on other lung function parameters and on clinical outcome measures.<br>? To assess the safety and tolerability of study treatments.;Primary end point(s): FEV1 AUC0-12h normalised by time on Day 42;Timepoint(s) of evaluation of this end point: Day 42<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline in peak FEV1 .<br>Safety (Adverse Events and Adverse Drug Reactions)<br>;Timepoint(s) of evaluation of this end point: Day 42<br>(across the study for the safety)