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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.
Information provided by:
Novartis Identifier:
First received: December 5, 2007
Last updated: April 27, 2011
Last verified: April 2011
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
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


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

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
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Please refer to this study by its identifier: NCT00568503

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

Responsible Party: External Affairs, Novartis Identifier: NCT00568503     History of Changes
Other Study ID Numbers: CQAX028A2102
Study First Received: December 5, 2007
Last Updated: April 27, 2011

Keywords provided by Novartis:

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants processed this record on August 21, 2017