The effectiveness of Tiotropium bromide in patients with severe asthma

Study of the effectiveness of Tiotropium bromide in patients with severe asthma

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20181015041353N1

Enrollment

Registered

2018-11-01

Start date

2018-11-22

Completion date

Unknown

Last updated

2019-01-14

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

Conditions

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

Interventions

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. Interve

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mohammad Ali Mir Jahanbakhsh

Zahedan University of Medical Sciences

dr.mirjahan@zaums.ac.ir+98 54 3329 5564

Outcome results

None listed

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