A clinical trial to assess the most efficacious dose of bronchodilator, Glycopyrrolate, to add to the existing treatment (Foster®, Beclomethasone + Formoterol) for the development of a new triple therapy in a single aerosol for the treatment of patients suffering from severe COPD.

• Conditions: Chronic Obstructive Pulmonary Disease; MedDRA version: 14.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-003588-31-HU
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-20
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Male and female adults (40 = age = 80 years) with written informed consent obtained prior to any study-related procedure.
2. Outpatients with a diagnosis of COPD (according to GOLD guidelines) with:
A smoking history of at least 10 pack years (pack-years = ((number of cigarettes per day x number of years)/20). Current and ex-smokers are eligible.
(Smoking cessation therapy must be completed within 3 months prior to screening visit and smoking status shall not change after screening and during the study period)
- A Post-bronchodilator 30%=FEV1<60% of the predicted normal value
- A Post-bronchodilator FEV1/FVC < 0.7
- An increase from baseline of FEV1 value 30 min after 80µg ipratropium of at least 60mL
3. Patients treated with double therapy with inhaled corticosteroids/long-acting ß-agonist combination or with triple therapy with inhaled corticosteroids/long-acting ß-agonist combination and long-acting anticholinergic (tiotropium) if taken for not more than one month at stable regimen before screening.
4. A cooperative attitude and ability to be trained to use correctly the pMDI inhalers.

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 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108

Exclusion Criteria

1.Pregnant or lactating women.
In case of childbearing potential, patients and/or their partner must be willing to use an approved method of contraception unless they meet the post-menopausal definition (amenorrhea>12 Mo or >6 Mo with FSH >40 mIU/ml). Methods of contraception may include one or more of the following ones: Surgical sterilization, hormonal contraception, double-barrier methods and periodic abstinence
Reliable contraception should be maintained throughout the study.
2.Diagnosis of asthma or history of allergic rhinitis or atopy.
3.Participation in another clinical trial where investigation drug was received less than 8 weeks prior to first intake of the study medication.
4.Hospitalisation for COPD or pneumonia within 3 month prior to screening
5.Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics in the 4 weeks prior to screening and during the run-in period.
6.Patients treated with oral/parenteral ß2-agonists or nebulised bronchodilators or PDE inhibitors in the 4 weeks prior to screening and during the run-in period.
7.Use of antibiotics for a lower respiratory tract infection in the 4 weeks prior to screening and during the run-in period.
8.Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
9.Known respiratory disorders other than COPD including but not limited to alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
10.Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic.
11.History of hypersensitivity to M3 Antagonists, ß2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial.
12.History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit
13.An abnormal and clinically significant 12-lead ECG that results in active medical problem.
14.Electrocardiogram (ECG) (12 lead) with QTcF >450 ms for males or QTcF > 470 ms for females.
15.Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the feasibility of the results of the study according to investigator’s judgement.
16.Patients with serum potassium levels < 3.5 mEq/L (or 3.5 mmol/L).
17.Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. uncontrolled coronary artery disease, uncontrolled hypertension); uncontrolled gastrointestinal disease (e.g. active peptic ulcer); neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, or other which may impact the feasibility of the results of the study according to investigator’s judgment.
18.Evidence of heart failure (NYHA class IV).
19.Changes in dose, schedule, formulation or product of oral xanthine derivatives (eg theophylline) in the three months prior to screening visit.
20.Change in dose, schedule, formulation or product of ß-blockers in the month prior to screening.

Study & Design

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