A 26-week treatment, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety and tolerability of NVA237 in patients with chronic obstructive pulmonary disease.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

1. Male or female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
2. Patients with moderate to severe stable COPD (Stage II or Stage III) according to the (GOLD Guidelines 2008).
3. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
4. Patients with a post-bronchodilator FEV1 =30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (day -14)
5. Patients, according to daily electronic diary data between Visit 2 (-14) and Visit 3 (day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3 (For scoring information see Section 7.4.3.1.)

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

Exclusion Criteria

1. Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
2. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/ml, OR have past 6 weeks from surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception:
• surgical sterilization (e.g., bilateral tubal ligation),
• double barrier method (diaphragm plus condom)
• hormonal contraception (implantable, patch, oral, IM), and copper coated IUD), if accepted by local regulatory authority and ethics committee.
• At the discretion of the investigator, total abstinence is acceptable in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance; if accepted by local regulatory authority and ethics committee.
• Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. NOTE: Reliable contraception should be maintained throughout the study
3. Patients requiring long term oxygen therapy (> 15 h a day) 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 between Visit 1 (day -21) and Visit 3 (day 1).
4. Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1 (day -21). Patients who develop a lower respiratory tract infection or COPD exacerbation during the screening period (up to Visit 3 (day 1)) will not be eligible, but will be permitted to be re-screened at a later date (at least 6 weeks after the resolution of the lower respiratory tract infection).
5. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to):
• unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable AF)
• history of malignancy of any organ system (including lung cancer), 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.
• narrow-angle glaucoma
• symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention
• any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
6. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at visit 1) or onset of symptoms prior to age 40 years.
7. Patients with known history and diagnosis of ?-1 antitrypsin deficiency
8. Patients involved in the active phase of a supervised pulmonary rehabilitation programme
9. Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by x-ray to be no longer active) or clinically significant bronchiectasis
10. Patients with allergic r

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • Confirm that NVA237 50µg o.d. (delivered via a SDDPI) vs. placebo significantly increases trough FEV1 (defined as mean evaluation at 23 h 15 min and 23h 45min post dose) following 12 weeks of treatment in patients with moderate to severe COPD (GOLD Guidelines 2008);Secondary Objective: • Evaluate the effect of NVA237 (50µg o.d.) vs. placebo on breathlessness measured using the Transition Dyspnea Index (TDI) after 26 weeks treatment.<br>• Evaluate the effect of NVA237 (50µg o.d.) vs. placebo on health status by measuring the total score of the St George’s Respiratory Questionnaire (SGRQ) after 26 weeks treatment.<br><br>Other secondary objectives are outlined in the Protocol.;Primary end point(s): - FEV1<br>- Transitional Dyspnea Index

Secondary Outcome Measures