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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: QAX028; Drug: QAX028; Drug: Tiotropium; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, CA
      • Advanced Clinical Research Institute, 1211 W. La Palma Ave
  • Illinois
    • Normal, Illinois, United States, IL61761
      • Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive
  • South Carolina
    • Spartanburg, South Carolina, United States, SC 29303
      • Spartanburg Medical Research, 485 Simuel Road
  • Tennessee
    • Knoxville, Tennessee, United States, TN 37920
      • New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo to QAX028 via inhalation device
Active Comparator: Tiotropium	Drug: Tiotropium; Tiotropium via inhalation device
Experimental: QAX028 high dose	Drug: QAX028; QAX028 60 mcg via inhalation device; Drug: QAX028; QAX028 20 mcg via inhalation device
Experimental: QAX028 low dose	Drug: QAX028; QAX028 60 mcg via inhalation device; Drug: QAX028; QAX028 20 mcg via inhalation device

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CQAX028A2201 from the Novartis Clinical Trials website

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: February 12, 2010
• First Submitted That Met QC Criteria: February 12, 2010
• First Posted (Estimate): February 15, 2010

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: COPD; Long acting muscarinic antagonist
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: CQAX028A2201