Safety and Efficacy of Multiple Doses of QAX028 in Chroni... | NCT01068613

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

NCT01068613

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 19, 2020Actual

Enrollment

62Actual

Phase

Phase 2

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

QAX028
QAX028
Tiotropium
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Feb 12, 2010

First Submission Date that Met QC Criteria

Feb 12, 2010

First Posted Date

Feb 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

May 2, 2012

Certification/Extension First Submitted that Passed QC Review

May 2, 2012

Certification/Extension First Posted Date

May 4, 2012Estimated

Last Update Submitted Date

Dec 11, 2020

Last Update Posted Date

Dec 19, 2020Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
QAX028 high dose	Experimental	Drug: QAX028
QAX028 low dose	Experimental	Drug: QAX028
Tiotropium	Active Comparator	Drug: Tiotropium
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QAX028	Drug	QAX028 60 mcg via inhalation device	QAX028 high dose
QAX028

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Advanced Clinical Research Institute, 1211 W. La Palma Ave		Anaheim	California	CA	United States

References Module

Citations

Not provided

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

ID	Term
D012602	Scopolamine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds