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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01068613
Recruitment Status : Completed
First Posted : February 15, 2010
Last Update Posted : May 4, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: QAX028 Drug: Tiotropium Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2010
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium [ Time Frame: 7 days treatment ]

Secondary Outcome Measures :
  1. Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium [ Time Frame: 7 days treatment ]
  2. Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo [ Time Frame: 7 days treatment ]
  3. Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients [ Time Frame: 7 days treatment ]
  4. Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028 [ Time Frame: 7 days treatment ]
  5. Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients [ Time Frame: 7 days treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01068613

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

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01068613     History of Changes
Other Study ID Numbers: CQAX028A2201
First Posted: February 15, 2010    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Long acting muscarinic antagonist

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action