Safety and Tolerability QAT370 Compared to Tiotropium in... | NCT00532350

Studies
Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease

NCT00532350

Sponsor

Novartis

Status

Completed

Last Update Posted

Dec 19, 2020Actual

Enrollment

22Actual

Phase

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

QAT370
Placebo
Tiotropium

Countries

Germany

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

Sep 2010

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

Jul 2007

Primary Completion Date

Not provided

Completion Date

Jan 2008Actual

First Submitted Date

Sep 19, 2007

First Submission Date that Met QC Criteria

Sep 19, 2007

First Posted Date

Sep 20, 2007Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2020

Last Update Posted Date

Dec 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	QAT370	Drug: QAT370
2	Placebo Comparator	Placebo	Drug: Placebo
3	Active Comparator	Tiotropium	Drug: Tiotropium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QAT370	Drug		1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Forced expiratory volume in 1 second		Days 1 and 7

Secondary Outcomes

Measure	Description	Time Frame
Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity.		Days 1 and 7

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients between 40 and 80 years of age with controlled COPD.
Women must be surgically sterilized or postmenopausal. Additional birth control and post-menopausal information will be available at time of enrollment.
Body mass index (BMI) must be within the range of 18 to 32 kg/m2

Exclusion Criteria:

Participation in any interventional clinical investigation with 4 weeks of study start
Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start
Past medical personal or close family history of clinically significant ECG abnormalities
Any medical condition that may interfere with exercise testing or that may make spirometry unsafe
A known hypersensitivity to the drug.
History of immunocompromise, including a positive HIV test result.
History of drug or alcohol abuse within 12 months of study start
Any condition that may compromise patient safety

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

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	Investigative site	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis investigative site		Berlin			Germany
Novartis Investigative site

Label	URL
Results for CQAT370A2103 can be found on the Novartis Clinical Trial Results Website	View source

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069447	Tiotropium Bromide

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided