MedPath

The therapeutic effect of inhaled budesonide in patients with unexplained chronic cough.

Phase 3
Recruiting
Conditions
unexplained chronic cough.
Cough
Registration Number
IRCT2013031212419N2
Lead Sponsor
The budget will be funded by researchers.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
68
Inclusion Criteria

age over 18 years; unexplained chronic cough for more than 8 weeks; absence of underling cardiac diseases; do not using smoking and drugs; absence of clinical and para-clinical asthma evidence; normal chest x-ray; normal spirometry; absence of eosinophilic bronchitis (sputum eosinophil percentage less than 3%); negative (normal) inhaled methacholine provocation test; signed written consent; absence of pregnancy and breast feeding; did not taking steroids during the last 3 months; do not receive any treatment for chronic cough before and during study; do not taking Angiotensin converting enzyme inhibitors (ACEI).
Exclusion criteria: dissatisfaction to continuing cooperation in each stage of the study; exacerbation or other accidents which requiring treatment; lack of returning within 48 hours of the deadline for second visit.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Budesonide inhalation treatment response in Numeric Cough Score questionnaire. Timepoint: Before intervention and a day after it. Method of measurement: Questionnaire.;Budesonide inhalation treatment response in visual analogue scale score. Timepoint: Before intervention and a day after it. Method of measurement: Questionnaire.
Secondary Outcome Measures
NameTimeMethod
Budesonide inhalation treatment response with Forced Oscillation Technique spirometry parameters. Timepoint: Before intervention in two periods; before and after methacholine challenge test and a day after intervention. Method of measurement: Forced Oscillation Technique spirometry.;Budesonide inhalation treatment response with Fractional Exhaled Nitric Oxide. Timepoint: Before intervention and the day after it. Method of measurement: Fractional Exhaled Nitric Oxide test.
© Copyright 2025. All Rights Reserved by MedPath