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Safety, Tolerability and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide and Placebo in Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD) Patients.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568503
First Posted: December 6, 2007
Last Update Posted: April 28, 2011
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.
Information provided by:
Novartis
  Purpose
This will be a single dose Proof-of-Concept study in mild-to-moderate COPD patients. The study will investigate the safety and tolerability of QAX028 as well as the bronchodilatory effects of QAX028 compared to tiotropium and placebo in mild-to-moderate COPD patients.

Condition Intervention Phase
COPD Drug: QAX028 Drug: Placebo Drug: Tiotropium bromide Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Partially Blinded, Single-dose, Cross-over Proof of Concept Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide (Positive Control) and Placebo in Mild-to-moderate COPD Patients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety, tolerability and pharmacodynamics of a single dose of QAX028 compared to tiotropium bromide 18μg and to placebo. [ Time Frame: throughout the study ]

Secondary Outcome Measures:
  • The forced expiratory volume in 1 second (FEV1)and time profile using a kinetic pharmacodynamic (KPD) model on single doses of QAX028. Pharmacokinetics of inhaled doses of QAX028. [ Time Frame: throughout the study ]

Enrollment: 29
Study Start Date: October 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
QAX028 high dose
Drug: QAX028
Placebo Comparator: 2
Placebo
Drug: Placebo
Active Comparator: 3
Tiotropium bromide
Drug: Tiotropium bromide
Active Comparator: 4
QAX028 medium dose
Drug: QAX028
Active Comparator: 5
QAX028 low dose
Drug: QAX028

  Eligibility

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.


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

Inclusion Criteria:

  • Male or female patients aged 40-75 years with diagnosis of mild or moderate COPD
  • Current or X-smokers with a smoking history of >10 pack-years.
  • Screening ipratropium post-bronchodilation FEV1 at 1 h post-dose will be greater than 50% of the normal predicted FEV1 value.

Exclusion Criteria:

  • Patients who can not comply with the following washout periods for standard

COPD treatments as follows should be excluded:

  • Short-acting bronchodilators
  • Long-acting bronchodilators
  • Inhaled steroids

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00568503


Locations
Denmark
Novartis Investigator Site
Birkeroed, Denmark
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: NOVARTIS Novartis investigative site
  More Information

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00568503     History of Changes
Other Study ID Numbers: CQAX028A2102
First Submitted: December 5, 2007
First Posted: December 6, 2007
Last Update Posted: April 28, 2011
Last Verified: April 2011

Keywords provided by Novartis:
COPD/TIOTROPIUM/QAX028

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Tiotropium Bromide
Bromides
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants