A multi-center, randomized, double-blind, placebo- controlled, two-period cross-over study to assess the effect of 50µg inhaled NVA237 on exercise endurance in patients with moderate to severe COPD - n/a

• Register: EUCTR
• Last refreshed on: 15 April 2013
• Main ID: EUCTR2010-018597-20-DE
• Date of registration: 29/06/2010
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: A multi-center, randomized, double-blind, placebo- controlled, two-period cross-over study to assess the effect of 50µg inhaled NVA237 on exercise endurance in patients with moderate to severe COPD - n/a
• Scientific title: A multi-center, randomized, double-blind, placebo- controlled, two-period cross-over study to assess the effect of 50µg inhaled NVA237 on exercise endurance in patients with moderate to severe COPD - n/a
• Date of first enrolment: 28/09/2010
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018597-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany, Italy, United Kingdom

Key inclusion & exclusion criteria

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 (clinical diagnosis in compliance with 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 =40 and < 70% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 during screening.
(Post refers to the highest postbronchodilator value after inhalation of 80 µg ipratropium bromide).
5. Increase in FEV1 from Pre-bronchodilator to Post-bronchodilator assessment of at least 5%
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); and women of child-bearing potential, UNLESS they meet protocol-specified requirements to prevent pregnancy
2. Patients who have had a COPD exacerbation (whether hospitalized or not) in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 4.
3. Patients with a Wmax value <20 W (as determined by the incremental cycle endurance test) at Visit 2.
4. Patients, whose exercise endurance time at sub-maximal workload is above 25 min at baseline
5. Patients with contraindications to cardiopulmonary exercise testing
6. 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
7. Patients with any history of asthma (as diagnosed by GINA guidlines)

Additional exclusion criteria are listed in the protocol.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease (COPD)
MedDRA version: 12.1 Level: LLT Classification code 10010952 Term: COPD

Intervention(s)

Product Name: Glycopyrrolate
Product Code: NVA237
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: GLYCOPYRRONIUM BROMIDE
CAS Number: 596510
Current Sponsor code: NVA237
Other descriptive name: Glycopyrrolate
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Primary end point(s): To determine the effect of 50 µg NVA237 compared with matching placebo inhaled once daily on exercise tolerance as measured by exercise endurance time during a sub-maximal constant-load cycle ergometry test (SMETT) after three weeks of treatment.

Secondary Objective: To determine the effect of 50 µg NVA237 compared with placebo on isotime inspiratory capacity (IC) during SMETT after three weeks of treatment.

Additional secondary and exploratory objectives are listed in the protocol.

Main Objective: To determine the effect of 50 µg NVA237 compared with matching placebo inhaled once daily on exercise tolerance as measured by exercise endurance time during a sub-maximal constant-load cycle ergometry test (SMETT) after three weeks of treatment.

Secondary ID(s)

CNVA237A2310

2010-018597-20-GB