A RESEARCH STUDY TO EVALUATE THE EFFECT OF A NEW MEDICINE (GLYCOPYRROLATE) COMPARED TO PLACEBO, BOTH BEING TAKEN ALTERNATELY IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
- Conditions
- CHRONIC OBSTRUCTIVE PULMONARY DISEASETherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]MedDRA version: 17.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855
- Registration Number
- EUCTR2013-005268-25-BG
- Lead Sponsor
- CHIESI FARMACEUTICI SPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
1. Male and female adults (40 = age = 80 years) with written informed
consent obtained prior to any study-related procedure.
2. Patients with a diagnosis of COPD at least 12 months before the
screening visit (according to GOLD guidelines, revised February 2013).
3. Current smokers or ex-smokers who quit smoking at least 6 months
prior to the screening visit.
4. A post-bronchodilator FEV1 < 60% of the predicted normal value and
a post-bronchodilator FEV1/FVC < 0.7 within 30 min after 4 puffs (4 x
100 µg) of salbutamol pMDI.
5. Patients with a positive response to the reversibility test at screening
within 30 minutes after administration of 400 µg (4 x 100 µg) of
salbutamol pMDI, defined as ?FEV1 = 5%.
6. Symptomatic patients at screening with a BDI focal score = 10.
7. Patients treated with double therapy for at least 1 month prior to
screening visit with either:
a. inhaled corticosteroids/long-acting ß2-agonist combination treatment
(fixed and/or free);
b. inhaled corticosteroids/long-acting muscarinic antagonist
combination.
8. Patients free of exacerbations for at least 1 month prior to screening
and during the run-in period.
9. A cooperative attitude and ability to be trained to use correctly the
pMDI inhaler.
10. A cooperative attitude and ability to be trained to use correctly the
electronic devices with COPD questionnaires.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. Inability to carry out pulmonary lung function testing, to comply with
study procedures or with study treatment intake.
2. Pregnant or lactating women and all women physiologically capable of
becoming pregnant (i.e. women of childbearing potential) UNLESS are
willing to use one or more of the reliable methods of
contraception.
3. Diagnosis of asthma or medical history of asthma.
4. Patients treated with long-acting antihistamines unless taken at
stable regimen at least 2 months prior to screening and to be maintained
constant during the study or if taken as PRN.
5. Use of antibiotics for a lower respiratory tract infection in the 4 weeks
prior to screening and during run-in period.
6. Patients requiring long term (at least 12 hours daily) oxygen therapy
for chronic hypoxemia.
7. Known respiratory disorders other than COPD which may impact the
efficacy or the safety of the study drug according to investigator's
judgement.
8. Patients who have a clinically significant cardiovascular condition
according to investigator's judgement
9. Patient with persistent, long standing persistent or permanent atrial fibrillation.
10. An abnormal and clinically significant 12-lead ECG which may impact
the safety of the patient according to investigator's judgement.
11. Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy
or bladder neck obstruction that in the opinion of the investigator would
prevent use of anticholinergic agents.
12. History of hypersensitivity to anticholinergics, ß2-agonist,
corticosteroids or any of the excipients contained in any of the
formulations used in the trial which may raise contra-indications or
impact the efficacy of the study drug according to the investigator's
judgement.
13. Clinically significant laboratory abnormalities indicating a significant
or unstable concomitant disease which may impact the efficacy or the
safety of the study drug according to investigator's judgement.
14. Patients with serum potassium levels <3.5 mEq/L (or 3.5 mmol/L)
or > 5.5 mEq/L (or 5.5 mmol/L).
15. Unstable concurrent disease: e.g. uncontrolled hyperthyroidism,
uncontrolled diabetes mellitus or other endocrine disease; significant
hepatic impairment; significant renal impairment; uncontrolled
gastrointestinal disease (e.g. active peptic ulcer); uncontrolled
neurological disease; uncontrolled haematological disease; uncontrolled
autoimmune disorders, or other which may impact the efficacy or the
safety of the study drug according to investigator's judgment.
16. History of alcohol abuse and/or substance/drug abuse within 12
months prior to screening visit.
17. Participation in another clinical trial where investigation drug was
received less than 8 weeks (or 5 half-lives for biologic products with
slow elimination) prior to screening visit.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the superiority of CHF 5259 pMDI versus placebo in terms of change from baseline in pre-dose morning FEV1 on Day 28.;Secondary Objective: To evaluate the effect of CHF 5259 pMDI in terms of FEV1 AUC0-12h normalised by time on Day 28.<br>To evaluate the effect of CHF 5259 pMDI on other lung function parameters, patient’s health status (symptom scores) and on clinical outcome measures.<br>To assess the safety and tolerability of the study treatment.;Primary end point(s): Change from baseline in pre-dose morning FEV1 on Day 28;Timepoint(s) of evaluation of this end point: DAY 28
- Secondary Outcome Measures
Name Time Method Secondary end point(s): FEV1 AUC0-12h normalised by time on Day 28;<br>change in other lung function parameters (trough and peak FEV1, FVC, IC,TDI score, SGRQ score, rescue medication intake).;Timepoint(s) of evaluation of this end point: DAY 1 AND/OR DAY 28