Clinical trial NCT01068613: Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Long acting muscarinic antagonist
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-02-15
Enrollment: 62
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/exclusion criteria may apply

Primary outcomes:
measure: Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium
timeFrame: 7 days treatment
Secondary outcomes:
measure: Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium
timeFrame: 7 days treatment
measure: Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo
timeFrame: 7 days treatment
measure: Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients
timeFrame: 7 days treatment
measure: Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028
timeFrame: 7 days treatment
measure: Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients
timeFrame: 7 days treatment
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute, 1211 W. La Palma Ave
state: California
city: Normal
country: United States
facility: Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive
state: Illinois
city: Spartanburg
country: United States
facility: Spartanburg Medical Research, 485 Simuel Road
state: South Carolina
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway
state: Tennessee
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: