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.

First Received: December 5, 2007 Last Updated: March 7, 2008 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00568503

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 I

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide Tiotropium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	36
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
1: Active Comparator QAX028 high dose	Drug: QAX028
2: Placebo Comparator Placebo	Drug: Placebo
3: Active Comparator Tiotropium bromide	Drug: Tiotropium bromide
4: Active Comparator QAX028 medium dose	Drug: QAX028
5: Active Comparator QAX028 low dose	Drug: QAX028

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568503

Locations

Denmark
Novartis Investigator Site
Birkeroed, Denmark

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

NOVARTIS

Novartis investigative site

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CQAX028A2102
Study First Received:	December 5, 2007
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00568503 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Novartis:

COPD/TIOTROPIUM/QAX028

Study placed in the following topic categories:

Neurotransmitter Agents
Cholinergic Antagonists
Anti-Asthmatic Agents
Cholinergic Agents
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides

Lung Diseases
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Anticonvulsants
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases

Bromides
Autonomic Agents
Lung Diseases
Therapeutic Uses
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Central Nervous System Agents
Anticonvulsants
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 06, 2009