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

Clinical trial of recovery rate comparison in patients with unexplained chronic cough in the two groups receiving oral cetirizine with and without inhaled budesonide.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013031212419N2
Enrollment
68
Registered
2017-11-19
Start date
2017-11-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unexplained chronic cough. Cough

Interventions

Intervention 1: Intervention group or Intervene 1: Treatment will be done by cetirizine (letizen®) 10 milligram oral daily plus inhale budesonide Turbuhaler 200 microgram 2 puff every 12 hours for 25
Treatment - Drugs
Intervention group or Intervene 1: Treatment will be done by cetirizine (letizen®) 10 milligram oral daily plus inhale budesonide Turbuhaler 200 microgram 2 puff every 12 hours for 25 days.
Control group or Intervene 2: Treatment will be done by cetirizine (letizen®) 10 milligram oral daily plus Turbuhaler without effective drug (placebo) 2 puff every 12 hours for 25 days.

Sponsors

The budget will be funded by researchers.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi Yadollahzadeh

Tehran University of Medical Sciences

m_yad@yahoo.com+98 21669390019

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026