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COMPLETEDPHASE1

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

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

NCT00568503•Novartis

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Novartis Investigator Site

Birkeroed, Denmark

Key Dates

Start Date

October 1, 2007

Primary Completion Date

February 1, 2008

Completion Date

February 1, 2008

Last Updated

April 28, 2011

Enrollment

ACTUAL participants

Conditions

COPD

Interventions

QAX028

DRUG

Placebo

DRUG

Tiotropium bromide

DRUG

QAX028

DRUG

QAX028

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

Effect of Telenursing on Oral Health

NCT07462221

COPD

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RECRUITINGNA

Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

NCT07351929

COPD Exacerbation

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 28, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

Effect of Telenursing on Oral Health

Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

Probiotics in Pulmonaty Rehabilitation for COPD

Effects of Eccentric Exercise Training in Patients With COPD

Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3