Correlation Between Five Asthma Control Questionnaires | NCT01350661

Studies
Correlation Between Five Asthma Control Questionnaires

NCT01350661

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Status

Completed

Last Update Posted

Aug 10, 2015Estimated

Enrollment

99Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Belgium

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

Aug 2015

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

Jun 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

May 9, 2011

First Submission Date that Met QC Criteria

May 9, 2011

First Posted Date

May 10, 2011Estimated

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

Aug 7, 2015

Last Update Posted Date

Aug 10, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Inge Muylle, Dr. Inge Muylle, Centre Hospitalier Universitaire Saint PierrePrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire Saint PierreOTHER

Collaborators

Not provided

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

This observational study aims to assess the correlation between many questionnaires designed to assess the level of control of asthma. The five questionnaires will be submitted, at the same time and in a random order, to asthma patients. Some other parameters will be recorded (e.g. lung function, epidemiological data). The hypothesis is that the results of the questionnaires will be the same. If not, we will try to understand why.

The investigators will include 100 patients, stratified with relation to their level of asthma severity (25 patients for each level of severity - described by the GINA guidelines).

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

99Actual

Label	Type	Description	Intervention Names
Asthma control level assessment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of asthma control	The five questionnaires are completed succesively on the same time.	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of asthma confirmed by a pulmonologist
Patient have had a lung function testing on the same day than the questionnaires are fulfilled.
Age equal or upper than 18 years
Agreement to participate to this study

Exclusion Criteria:

Age under 18 years
Refusal to participate to this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients seen at the consultation of pulmonology of a tertiary hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU St Pierre; pulmonology department		Brussels		1000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23890766	Derived	Vermeulen F, de Meulder I, Paesmans M, Muylle I, Bruyneel M, Ninane V. Asthma control measurement using five different questionnaires: a prospective study. Respir Med. 2013 Sep;107(9):1314-21. doi: 10.1016/j.rmed.2013.07.003. Epub 2013 Jul 26.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases