A 52-week treatment, randomized, double-blind, placebo-controlled, with open label tiotropium, parallelgroupstudy to assess the efficacy, safety and tolerability of NVA237 in patients with chronic obstructivepulmonary disease - ND
- Conditions
- Chronic obstructive pulmonary diseaseMedDRA version: 9.1Level: LLTClassification code 10009032
- Registration Number
- EUCTR2008-008394-63-IT
- Lead Sponsor
- ovartis Pharma Service AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1065
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
1. Pregnant women or nursing mothers
2. Women of child-bearing potential, as defined in the protocol
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 a history of long QT syndrome or whose QTc measured at Visit 1 (day -21) (Fridericia method) is
prolonged (>450 ms for males or >470 for females).
8. Treatments for COPD and allied conditions: the following medications should not be used between Visits 1
(day -21) and 3 (day 1).
The minimum washout prior to Visit 2 (Day -14) is specified below. For patients in the Holter monitor sub-group
minimum washout is prior to the day before Visit 2 (day -15):
The long acting anticholinergic agent tiotropium:7 days.
Short acting anticholinergics: 8 h
Fixed combinations of β2-agonists and inhaled corticosteroids: 48 hours. (Patients taking fixed combinations of
β2-agonists and inhaled corticosteroids must be switched to the equivalent inhaled corticosteroid as monotherapy
plus salbutamol/albuterol as rescue therapy at least 48 hours prior to Visit 2)
Long-acting β2-agonists: 48 h
Short acting β2-agonists (other than those prescribed in the study): 6 h
Theophylline (any formulation): 7 days
Combinations of inhaled short acting anticholinergics and short acting β2-agonists: 12 hours
9. Patients who need the following treatments for COPD and allied conditions unless they have been stabilized
as follows:
Inhaled corticosteroids, in recommended and constant doses and dose regimens (previously given as part of a
fixed dose combination of LABA + ICS) at least one month prior to Visit 1.
Intranasal corticosteroids, in recommended and constant doses and dose regimens - at least one month prior to
Visit 1.
H1 antagonists at least 5 days prior to Visit 1.
10. Long term oral prednisone therapy (or equivalent), defined as ≥
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To confirm that NVA237 50&#956;g o.d. (delivered via a SDDPI) vs placebo significantly increases mean 24 h<br>post-dose (trough) FEV1 following 12 weeks of treatment in patients with moderate to severe COPD (GOLD<br>Guidelines 2008);Secondary Objective: evaluate the effect of NVA237 (50&#956;g o.d.) vs placebo on breathlessness measured using the Transition Dyspnea<br>Index (TDI) after 26 weeks treatment.<br> evaluate the effect of NVA237 (50&#956;g o.d.) vs placebo on the total score of the St Georges Respiratory<br>Questionnaire (SGRQ) after 52 weeks treatment.;Primary end point(s): Mean trough FEV1 after 12 weeks treatment imputed with LOCF
- Secondary Outcome Measures
Name Time Method