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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

QAX028

Tiotropium

Placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Long acting muscarinic antagonist

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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/exclusion criteria may apply

Sites / Locations

Advanced Clinical Research Institute, 1211 W. La Palma Ave
Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive
Spartanburg Medical Research, 485 Simuel Road
New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

QAX028 high dose

QAX028 low dose

Tiotropium

Placebo

Arm Description

Outcomes

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

Secondary Outcome Measures

Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium

Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo

Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients

Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028

Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients

Full Information

NCT ID

NCT01068613

First Posted

February 12, 2010

Last Updated

December 11, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01068613

Brief Title

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

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Long acting muscarinic antagonist

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QAX028 high dose

Arm Type

Experimental

Arm Title

QAX028 low dose

Arm Type

Experimental

Arm Title

Tiotropium

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

QAX028

Intervention Description

QAX028 60 mcg via inhalation device

Intervention Type

Drug

Intervention Name(s)

QAX028

Intervention Description

QAX028 20 mcg via inhalation device

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Intervention Description

Tiotropium via inhalation device

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to QAX028 via inhalation device

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium

Time Frame

7 days treatment

Title

Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo

Time Frame

7 days treatment

Title

Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients

Time Frame

7 days treatment

Title

Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028

Time Frame

7 days treatment

Title

Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients

Time Frame

7 days treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Advanced Clinical Research Institute, 1211 W. La Palma Ave

City

Anaheim

State/Province

California

ZIP/Postal Code

Country

United States

Facility Name

Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive

City

Normal

State/Province

Illinois

ZIP/Postal Code

IL61761

Country

United States

Facility Name

Spartanburg Medical Research, 485 Simuel Road

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

SC 29303

Country

United States

Facility Name

New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

TN 37920

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5765

Description

Results for CQAX028A2201 from the Novartis Clinical Trials website

Learn more about this trial

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

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