NCT02715167

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable healthy

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

1 month

First QC Date

March 4, 2016

Last Update Submit

March 16, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Leicester cough questionnaire

    5 minutes

Study Arms (2)

Group Budesonide

ACTIVE COMPARATOR

Inhaled corticoids

Drug: Budesonide novolizer

Group Placebo

PLACEBO COMPARATOR

Placebo by inhalation

Drug: Placebo

Interventions

Budesonide novolizerDRUG
Group Budesonide
PlaceboDRUG
Group Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic cough

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Rougui Ihsan, MD

CONTACT

ihsan.rougui@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 22, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2016

Study Completion

December 1, 2017

Last Updated

March 22, 2016

Record last verified: 2016-03