Safety, Tolerability and Pharmacodynamics of QAX028 Compared to Open-Label Tiotropium Bromide and Placebo in Mild-to-Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients. - Full Text View

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 Tiotropium bromide

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

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

Keywords provided by Novartis:

COPD/TIOTROPIUM/QAX028

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides

Lung Diseases
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 15, 2009