Safety and Tolerability of Multiple Inhaled NVA237 Doses in Chronic Obstructive Pulmonary Disease (COPD) Patients

A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Inhaled NVA237 Doses at Four Dose Levels in COPD Patients

This study will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses of the NVA237 in mild and moderate COPD patients .

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Placebo; Drug: NVA237

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Novartis Investigative Site
• Germany
  • Berlin, Germany
    • Novartis Investigative Site
  • Moenchengladbach, Germany
    • Novartis Investigative Site
  • Munich, Germany
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and/or female patients aged from 40-75 years of age with mild to moderate COPD.
• Diagnosis of mild/moderate COPD, according to the GOLD guidelines.
• Bronchodilatory response to ipratropium at screening
• Current or ex-smokers with a smoking history of >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.
• Female patients must have been surgically sterilized at least 6 months prior to screening or: Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion.
• Lab and post-bronchodilator values within a certain range.
• Body mass index (BMI) must be within the range of 18 to 32 kg/m2.

Exclusion Criteria:

• Any significant medical condition that in the opinion of the Investigator may compromise patient safety, patient compliance, interfere with evaluations, or preclude completion of the trial.
• Any medical condition that may make spirometry unsafe
• History of glaucoma, symptomatic prostatism or urinary retention.
• Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations and for any other limitation of participation based on local regulations. Previous participation in a study with either the investigational or comparator drugs does not exclude a patient from participation in this study.
• Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
• Significant illness (other than respiratory illness) within the two weeks prior to dosing.
• Clinically significant ECG abnormalities indicative of an unstable underlying cardiac problem, e.g. recent myocardial infarction, 2nd/3rd degree heart block, or a family history grandparents, parents and siblings of a prolonged QT-interval syndrome.
• History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.
• History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.
• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
• History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
• Patients who are unable to demonstrate appropriate use of the Concept 1 device at screening

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 5; Placebo	Drug: Placebo
EXPERIMENTAL: 1; NVA237	Drug: NVA237
EXPERIMENTAL: 2; NVA237	Drug: NVA237
EXPERIMENTAL: 3; NVA237	Drug: NVA237
EXPERIMENTAL: 4; NVA237	Drug: NVA237

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetics (PK) of NVA237 following single and repeated once-daily inhaled NVA237 doses

Secondary Outcome Measures

Outcome Measure
-Pharmacodynamics (PD) and PK/PD relationships of NVA237 following single and repeated once-daily inhaled NVA237 doses -Safety and tolerability of NVA237 following single and repeated once-daily inhaled NVA237 doses

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Study Completion (ACTUAL): October 1, 2007

Study Registration Dates

• First Submitted: October 15, 2007
• First Submitted That Met QC Criteria: October 15, 2007
• First Posted (ESTIMATE): October 17, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): January 8, 2008
• Last Update Submitted That Met QC Criteria: December 27, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: multiple inhaled, NVA237, COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Glycopyrrolate
• Other Study ID Numbers: CNVA237A2103