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IRCT2013031212419N2 IRCT 2017-11-19 The budget will be funded by researchers. 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. 2017-11-22 anticipated 68 Complete https://irct.ir/trial/12478 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: After obtaining relevant permissions from the University, patients with a chronic cough (more than 8 weeks), are considered as potential cases of entry into the study. They will be visited by experienced pulmonologist as the routine; sinusitis and gastroesophageal reflux based on history and physical examination and other documents will be refused. Then standard Chest radiography (Posteroanterior and Lateral view), spirometry and the smear of sputum smear analysis for eosinophil's percentage. Will be done. Those who have normal spirometry and chest radiography and sputum eosinophil percentage is less than 3%, referred for further evaluation. For these patients, the Forced Oscillation Technique (FOT) and (FENO) Fractional Exhaled Nitric Oxide and inhaled methacholine provocation challenge test (MCT) will be done. At this point, who with normal MCT will be selected and the project will be present. The benefits and consequences of treatment used and the running way they completely explained. Cases will be entre to the study, will be performed FOT and will be complete the information in checklists if accept to sign the written satisfaction. Block randomization will be used to enter cases to each group and will be interviewed by a trained interviewer to question questionnaire Numeric Cough Quality Score (NCS), Visual analog scale (VAS) and other information as needed to study and complete in the Check - List for each patient. In case of need defects in the information will be completed by the interviewer during the study in pursuit of the phone. Turbuhalers will be a lottery into two groups (A or B), also encoded by a table of random numbers. All patients according to the protocol of the Center for Drug, Cetirizine 10 (Letizen®) milligram daily plus a coded Turbuhaler and educated for correct consumption (2 puffs every 12 hours). Turbuhalers will be labeled only by numeric codes without any distinguishable symptom from others. After 25 days of treatment, patients will be visited by pulmonologist again, and FOT, FENO will be done and will be interviewed to complete the needed information. Then patients discharge from study to continue their treatment process. This process till the completion of the sample size will continue. Obtained information in the checklists will be analyzed by in SPSS 23 software. During the analysis first, numerical codes replaced by letters (A/B) for each Turbuhaler and after analysis in the results letter codes will be replaced by drug or placebo group. So Code information will be sealed and maintained until the final analysis away from patients, researchers, interviewer, and analyzer to blind the study. 3 unexplained chronic cough. 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 days. Intervention 2: 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.
public Mahdi Yadollahzadeh
Imam Khomeini Hospital, End of Keshavarz Blv.
Tehran Iran (Islamic Republic of) 1419733141 +98 21669390019 m_yad@yahoo.com Tehran University of Medical Sciences scientific Mehrnaz Asadi Gharabaghi
Imam Khomeini Hospital, End of Keshavarz Blv.
Tehran Iran (Islamic Republic of) +98 21669390019 asadi_m@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Both R05 Cough Treatment - Drugs 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. 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. 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. The budget will be funded by researchers. Approved 2017-03-28 Ethics Committee of Tehran University of Medical Sciences - Imam Khomeini Hospital Imam Khomeini Hospital, End of Keshavarz Blv. Tehran Iran (Islamic Republic of)