Influence of a Inhaled Corticosteroid Therapy Versus Cort... | NCT00515775

Studies
Influence of a Inhaled Corticosteroid Therapy Versus Corticosteroid + LABA Therapy on the FeNO of Asthmatic Children

NCT00515775

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Feb 13, 2009Estimated

Enrollment

27Estimated

Phase

Not provided

Conditions

Allergic Asthma

Interventions

Not provided

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

Oct 2008

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

Sep 2005

Primary Completion Date

Jun 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Aug 13, 2007

First Submission Date that Met QC Criteria

Aug 13, 2007

First Posted Date

Aug 14, 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

Feb 12, 2009

Last Update Posted Date

Feb 13, 2009Estimated

Description Module

Brief Summary

The purpose of the study is to investigate, whether the FeNO concentration of asthmatic children is influenced differently by inhaled corticosteroid compared to inhaled corticosteroid + long acting beta agonist. The study hypothesis is that the FeNO concentration is more decreased in patients with a combination therapy compared to those with a corticosteroid mono therapy.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

allergic asthma since > 6 months equal or lower corticosteroid therapy before study entry FEV1>50%

Exclusion Criteria:

severe asthma respiratory infection within the last 4 weeks smoking

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Allergic asthmatics

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Vogelberg, MD	University Children´s Hospital, Technical University of Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Children´s Hospital, Technical University of Dresden		Dresden		01307	Germany