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IRCT20181015041353N1 IRCT 2018-11-01 Zahedan University of Medical Sciences The effectiveness of Tiotropium bromide in patients with severe asthma Study of the effectiveness of Tiotropium bromide in patients with severe asthma 2018-11-22 anticipated 60 Complete https://irct.ir/trial/34528 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: Patients are randomly assigned to either placebo group or intervention using permuted block randomization.Permuted block randomization is a way to randomly allocate a participant to a treatment group, while maintaining a balance across treatment groups. Each “block” has a specified number of randomly ordered treatment assignments, Blinding description: Samples and clinical personnel (physicians , nurses ,physiotherapists and etc) who have responsibility of taking care of the patients and who ever has any direct contact with samples are blinded and researcher and and evaluator and The Data and Safety Monitoring Board (DSMB) are not blinded. 3 Condition 1: Moderate persistent asthma with status asthmaticus. Condition 2: Severe persistent asthma. Intervention 1: Intervention group: Name of drug : Capsule - Inhalation Tiotropium bromide 18 micrograms daily (one puff daily) for 4 weeks separately in phase 1 and 2, Made in India by CIPA. Intervention 2: Control group: Placebo. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Decision is under discussion of related and advisor Professors of the research.
public Seyed Mohammad Ali Mir Jahanbakhsh
Ali ibne abitaleb Hospital, Salamat Blvd., Persian Gulf Highway, Zahedan, Iran
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5564 dr.mirjahan@zaums.ac.ir Zahedan University of Medical Sciences scientific Seyed Mohammad Ali Mir Jahanbakhsh
Ali ibne abitaleb Hospital, Salamat Blvd., Persian Gulf Highway, Zahedan, Iran
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5564 dr.mirjahan@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Patients with severe asthma who have been treated with routine anti-asthma drugs Being under treatment with routine anti-asthma drugs Labeled as grade 4 or 5 of asthma Age of 18 years and more 18 years no limit Both Pregnancy lactation (Breastfeeding) Using hormonal contraceptives drugs High pregnancy probability Chronic obstructive pulmonary disease (COPD) Having other pulmonary diseases Infection of the respiratory system Audio cord performance dysfunction smokers with more than 10 pack per year History of taking muscarinic anticholinergic drugs History of taking other anticholinergic drugs Inability to use the drugs prescribed in this study J45.42 J45.5 Moderate persistent asthma with status asthmaticus Severe persistent asthma Treatment - Drugs Placebo Intervention group: Name of drug : Capsule - Inhalation Tiotropium bromide 18 micrograms daily (one puff daily) for 4 weeks separately in phase 1 and 2, Made in India by CIPA Control group: Placebo Forced expiratory volume in 1 second (FEV1). Timepoint: At the beginning and after Four weeks of phase one, and four weeks after the start of phase two. Between the two phases is a four weeks long washout period. Method of measurement: Spirometry. Asthma control test (ACT) score. Timepoint: At the beginning and after Four weeks of phase one, and four weeks after the start of phase two. Between the two phases is a four weeks long washout period. Method of measurement: By test score. The need for oral or injection of steroids. Timepoint: At the beginning and after Four weeks of phase one, and four weeks after the start of phase two. Between the two phases is a four weeks long washout period. Method of measurement: By the physician. Need of hospitalization. Timepoint: At the beginning and after Four weeks of phase one, and four weeks after the start of phase two. Between the two phases is a four weeks long washout period. Method of measurement: By the physician. Zahedan University of Medical Sciences Approved 2018-08-12 Ethics committee of Zahedan University of Medical Sciences ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)