CYT003-QbG10 for Treatment of Allergic Asthma Bronchial | NCT00890734

Studies
CYT003-QbG10 for Treatment of Allergic Asthma Bronchial

NCT00890734

Sponsor

Cytos Biotechnology AG

Status

Completed

Last Update Posted

Feb 13, 2012Estimated

Enrollment

63Actual

Phase

Phase 2

Conditions

Allergic Bronchial Asthma

Interventions

CYT003-QbG10
Placebo

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

Feb 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

Apr 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Apr 28, 2009

First Submission Date that Met QC Criteria

Apr 29, 2009

First Posted Date

Apr 30, 2009Estimated

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

Feb 10, 2012

Last Update Posted Date

Feb 13, 2012Estimated

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

Description Module

Brief Summary

The purpose of the study is to test whether treatment with CYT003-QbG10 can improve asthma symptoms in patients with allergic bronchial asthma. The active treatment will be compared against placebo.

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

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: CYT003-QbG10
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CYT003-QbG10	Drug	subcutaneous injection	1
Placebo

Measure	Description	Time Frame
Markers for inflammation and asthma		1-3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persistent allergic asthma bronchial requiring long-term treatment with inhaled corticosteroids
Further criteria as defined in the study protocol

Exclusion Criteria:

Use of oral corticosteroids within past 3 months
Hospitalization for asthma exacerbation within past 6 months
Uncontrolled asthma
Contraindication to any study test or procedure
Further criteria as defined in the study protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cytos Investigator Sites		Luebeck, Berlin, Wiesbaden, Rodgau, Eisenach			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23384679	Derived	Beeh KM, Kanniess F, Wagner F, Schilder C, Naudts I, Hammann-Haenni A, Willers J, Stocker H, Mueller P, Bachmann MF, Renner WA. The novel TLR-9 agonist QbG10 shows clinical efficacy in persistent allergic asthma. J Allergy Clin Immunol. 2013 Mar;131(3):866-74. doi: 10.1016/j.jaci.2012.12.1561. Epub 2013 Feb 4.