A randomized, double-blind, placebo controlled, parallel group, multi-center study, to assess the safety and tolerability of 28 days treatment with NVA237 (100 or 200µg once a day) in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10009033Term: Chronic obstructive pulmonary disease
- Registration Number
- EUCTR2007-000643-95-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
•Male or female adults aged 40 years or older.
•Patients with moderate to severe COPD according to the GOLD Guidelines (2006)
•Patients who have smoking history of at least 10 pack years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
•Patients with a post-bronchodilator FEV1 equal or greater than 30% of the predicted normal value and less than 80% of the predicted normal value, and post-bronchodilator FEV1/FVC less than 0.7 at visit 2. Predicted normal FEV1 should be calculated according to Quanjer predictive equations [Quanjer PH (1993)] (for details see Section 10 and Appendix 4)
•Written informed consent by the patient prior to initiation of any study-related procedure. (Study related procedures include the washout of inhaled beta 2-agonists, including the beta 2-agonist component of fixed dose combinations of inhaled beta 2-agonists and inhaled corticosteroids, prior to FEV1 measurements at visit 1)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to visit 1 or during the screening period
•Patients who have had a respiratory tract infection within 6 weeks prior to visit 1 or during the screening period
Patients who develop a respiratory tract infection during the screening period must discontinue from the trial, but will be permitted to re-enroll at a later date
•Patients with a history of asthma indicated by;blood eosinophil count > 400/mm3, Onset of symptoms prior to age 40 years.
•Patients with a history of long QT syndrome or whose QTc measured at visit 1 is prolonged.
•Patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
•Patients who, in the judgment of the investigator have a clinically relevant laboratory abnormality or a clinically significant condition such as unstable ischemic heart disease, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia, narrow-angle glaucoma, symptomatic prostatic hyperplasia, bladder-neck obstruction or moderate to severe renal impairment that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
•History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
Other medications / therapies
•Patients contraindicated for salbutamol treatment or who have shown an untoward reaction to inhaled anticholinergic agents.
•Patients who need the treatments for COPD and allied conditions unless they have had the minimum washout prior to visit 2 specified below:
•The long acting anticholinergic agent tiotropium: 7 days
•Short acting anticholinergics: 8 hours
•Fixed combinations of beta 2-agonists and inhaled corticosteroids: 48 hours
•Long-acting beta 2-agonists: 48 hours
•Short acting beta 2-agonists: 6 hours
•Theophylline: 7 days
•Combinations of inhaled anticholinergics and ß2 agonists: 24 hours
Patients taking steroid / ß2-agonist fixed combinations prior to visit 1 should be transferred to the same dose of steroid contained in the fixed combination and on-demand rescue medication for a period of 2 weeks prior to visit 2.
•Patients who need the following treatments for COPD and allied conditions unless they have been stabilized for at least one month prior to visit 1:
•Inhaled or nasal corticosteroids
•Cromoglycate, nedocromil, leukotriene antagonists in recommended and constant doses and dose regimens
•Patients taking ß blocking agents
Investigational drug / therapy use
•Use of other investigational drugs at the time of enrollment , or within 30 days or 5 half-lives of enrollment, whichever is longer
Ingredient hypersensitivity
•History of hypersensitivity to any of the study drugs including rescue medication or to drugs with similar chemical structures
Compliance / reliability / investigator’s judgment
•Patients who are in the opinion of the investigator known to be unreliable, or non-compliant, or with any condition or prior or present treatment rendering the patient ineligible for the study.
•Patients unable to use a dry powder inhaler (SDDPI) device or a pressurized MDI
•Patients unable to perform spirometry measurements or complete a diary card.
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Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method