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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00545311
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : January 8, 2008
Information provided by:

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: NVA237 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : July 2007
Actual Study Completion Date : October 2007

Arm Intervention/treatment
Experimental: 1
Drug: NVA237
Experimental: 2
Drug: NVA237
Experimental: 3
Drug: NVA237
Experimental: 4
Drug: NVA237
Placebo Comparator: 5
Drug: Placebo

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

Secondary Outcome Measures :
  1. -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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00545311

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Novartis Investigative site
Copenhagen, Denmark
Novartis investigative site
Berlin, Germany
Novartis investigative site
Moenchengladbach, Germany
Novartis Investigative Site
Munich, Germany
Sponsors and Collaborators
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Principal Investigator: Novartis Investigator site
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Responsible Party: External Affairs, Novartis Identifier: NCT00545311    
Other Study ID Numbers: CNVA237A2103
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: January 8, 2008
Last Verified: December 2007
Keywords provided by Novartis:
multiple inhaled, NVA237, COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs