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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00545311
First received: October 15, 2007
Last updated: December 27, 2007
Last verified: December 2007
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: NVA237
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Pharmacokinetics (PK) of NVA237 following single and repeated once-daily inhaled NVA237 doses

Secondary Outcome Measures:
  • -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

Enrollment: 40
Study Start Date: July 2007
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: 1
NVA237
Drug: NVA237
Experimental: 2
NVA237
Drug: NVA237
Experimental: 3
NVA237
Drug: NVA237
Experimental: 4
NVA237
Drug: NVA237
Placebo Comparator: 5
Placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545311

Locations
Denmark
Novartis Investigative site
Copenhagen, Denmark
Germany
Novartis investigative site
Berlin, Germany
Novartis investigative site
Moenchengladbach, Germany
Novartis Investigative Site
Munich, Germany
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00545311     History of Changes
Other Study ID Numbers: CNVA237A2103
Study First Received: October 15, 2007
Last Updated: December 27, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency

Keywords provided by Novartis:
multiple inhaled, NVA237, COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 22, 2014