The effectiveness of Tiotropium bromide in patients with severe asthma

Phase 3

Recruiting

Conditions: Condition 1: Moderate persistent asthma with status asthmaticus. Condition 2: Severe persistent asthma.
Moderate persistent asthma with status asthmaticus
Severe persistent asthma
J45.42

Registration Number: IRCT20181015041353N1

Lead Sponsor: Zahedan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.