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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01068613
First received: February 12, 2010
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: QAX028
Drug: Tiotropium
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium [ Time Frame: 7 days treatment ] [ Designated as safety issue: No ]
  • Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo [ Time Frame: 7 days treatment ] [ Designated as safety issue: No ]
  • Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients [ Time Frame: 7 days treatment ] [ Designated as safety issue: Yes ]
  • Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028 [ Time Frame: 7 days treatment ] [ Designated as safety issue: No ]
  • Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients [ Time Frame: 7 days treatment ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068613

Locations
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01068613     History of Changes
Other Study ID Numbers: CQAX028A2201
Study First Received: February 12, 2010
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
COPD
Long acting muscarinic antagonist

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Muscarinic Antagonists
Tiotropium
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013