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

NCT00545311 | Completed Phase 1

• 1 other identifier: CNVA237A2103
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 4

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)

Keywords

multiple inhaled, NVA237, COPD

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Study Arms (5)

1

EXPERIMENTAL

NVA237

Drug: NVA237

2

EXPERIMENTAL

NVA237

Drug: NVA237

3

EXPERIMENTAL

NVA237

Drug: NVA237

4

EXPERIMENTAL

NVA237

Drug: NVA237

5

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NVA237 DRUG

1

Placebo DRUG

5

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Lab and post-bronchodilator values within a certain range.
• Body mass index (BMI) must be within the range of 18 to 32 kg/m2.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (4)

Novartis Investigative site

Copenhagen, Denmark

Location

Novartis investigative site

Berlin, Germany

Location

Novartis investigative site

Mönchengladbach, Germany

Location

Novartis Investigative Site

Munich, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis

  Investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 17, 2007
• Study Start: July 1, 2007
• Study Completion: October 1, 2007
• Last Updated: January 8, 2008

Record last verified: 2007-12

Locations

DK (1); DE (3)