Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients

A Randomized, Double-blind, Double-dummy, Three Period Incomplete Cross-over Study to Evaluate the Safety and Efficacy of Multiple Daily Doses of QAX028 as Compared to Tiotropium Bromide (Positive Control) and Placebo in COPD Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01068613

Enrollment

Registered

2010-02-15

Start date

2010-01-31

Completion date

2010-08-31

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Long acting muscarinic antagonist

Brief summary

This study will assess the bronchodilator effects of multiple doses of QAX028 at two different dose levels when compared to tiotropium and placebo in a COPD population.

Interventions

DRUGQAX028

QAX028 60 mcg via inhalation device

DRUGTiotropium

Tiotropium via inhalation device

DRUGPlacebo

Placebo to QAX028 via inhalation device

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of COPD according to GOLD guidelines * Post-bronchodilator 30%≤FEV1\<80% of predicted normal and ost-bronchodilator FEV1/FVC \<0.7 * Smoking history of at least 10 pack years

Exclusion criteria

* Requiring oxygen therapy on a daily basis * Exacerbation of airway disease in the 6 weeks prior to screening or between screening and dosing * Lung reduction surgery * Respiratory tract infection in the 6 weeks prior to screening * Significant cardiac history * History of asthma with onset of symptoms prior to age 40 years * Active use of certain COPD medications, beta blockers Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium	7 days treatment

Secondary

Measure	Time frame
Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium	7 days treatment
Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo	7 days treatment
Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients	7 days treatment
Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028	7 days treatment
Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients	7 days treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026