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

NCT ID: NCT00545311

Last Updated: 2008-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2007-10-31

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

NVA237

Group Type: EXPERIMENTAL

NVA237

Intervention Type: DRUG

2

NVA237

Group Type: EXPERIMENTAL

NVA237

Intervention Type: DRUG

3

NVA237

Group Type: EXPERIMENTAL

NVA237

Intervention Type: DRUG

4

NVA237

Group Type: EXPERIMENTAL

NVA237

Intervention Type: DRUG

5

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

NVA237

Intervention Type: DRUG

NVA237

Intervention Type: DRUG

NVA237

Intervention Type: DRUG

NVA237

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

Novartis Investigative site

Copenhagen, , Denmark

Novartis investigative site

Berlin, , Germany

Novartis investigative site

Mönchengladbach, , Germany

Novartis Investigative Site

Munich, , Germany

Countries

Denmark; Germany

Other Identifiers

CNVA237A2103

Identifier Type: -

Identifier Source: org_study_id