Predictive Factors in Response to Inhaled Corticoids in C... | NCT02715167

Studies
Predictive Factors in Response to Inhaled Corticoids in Chronic Cough

NCT02715167

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown status

Last Update Posted

Mar 22, 2016Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

Budesonide novolizer
Placebo

Countries

Not provided

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

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Apr 2016Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Mar 4, 2016

First Submission Date that Met QC Criteria

Mar 16, 2016

First Posted Date

Mar 22, 2016Estimated

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

Mar 16, 2016

Last Update Posted Date

Mar 22, 2016Estimated

Description Module

Brief Summary

The hypothesis is that a high fractional exhaled nitric oxide can predict the response to inhaled corticoids in chronic cough.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Budesonide	Active Comparator	Inhaled corticoids	Drug: Budesonide novolizer
Group Placebo	Placebo Comparator	Placebo by inhalation	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Budesonide novolizer	Drug		Group Budesonide
Placebo

Measure	Description	Time Frame
Leicester cough questionnaire		5 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronic cough

Exclusion Criteria:

active smoker
treated by corticoids during the previous month
use of angiotensin-converting-enzyme inhibitor

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rougui Ihsan, MD	Contact			ihsan.rougui@hotmail.com

Overall Officials

Not provided

Locations

Not provided