Evaluation of the effect of budesonide nebulizer in patients with exacerbated COPD

Comparison and evaluation of the effect of budesonide nebulizer with oral systemic steroids on the amount of peak expiratory flow rate (PEFR) change using peak flowmetry of patients with exacerbated chronic obstructive pulmonary disease (COPD) referred to the emergency department; Non-inferiority Double-Blind Randomized Clinical Trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180523039800N1

Enrollment

Registered

2018-10-30

Start date

2018-09-06

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

Chronic obstructive pulmonary disease. Chronic obstructive pulmonary disease with (acute) exacerbation

Interventions

Intervention 1: Intervention group: ?Budesonide nebulizer (inhaled steroid), Jaber ebne Hayyan Co., 0.5 mg, 3 times, every 30 minutes, and single dose oral placebo tablet. Intervention 2: Control grou

Eligibility

Sex/Gender

All

Age

15 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients with exacerbated COPD following respiratory infection 15-70 years old Disease severity of moderate to severe based on GOLD scoring

Exclusion criteria

Exclusion criteria: Exacerbated COPD with a cause other than respiratory infection History of asthma, allergic rhinitis or atopy History of systemic corticosteroids more than 1500 micrograms/ day over the past month Patients with decreased consciousness Known psychological disorder and inability to cooperate in the study

Design outcomes

Secondary

Measure	Time frame
Variation in FEV1 percentage. Timepoint: 30 and 60 minutes and 3, 6, 12 and 24 hours later. Method of measurement: Spirometry.	—

Primary

Measure	Time frame
Variation in peak expiratory flow rate. Timepoint: 30 and 60 minutes, and 3, 6, 12, and 24 hours later. Method of measurement: Peak flow meter device.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTina Mirrajei

Tehran University of Medical Sciences

tina_mirrajei@yahoo.com+98 21 6693 9010

Outcome results

None listed

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