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
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
Design
Non-inferiority Double-Blind Randomized Phase II Clinical Trial
Settings and conduct
This study is performed on patients with exacerbated COPD that is referred to the emergency service of Imam Khomeini, Shariati and Sina Hospitals. Patients entered into the study will randomly be allocated to intervention and control groups. The intervention group treated with placebo tablets and budenoside nebulizer half a milligrams every 30 minutes to 3 doses and standard treatment. The control group is treated with Prednisolone Fort 50 mg, placebo nebulizer, and standard treatment. Then, patients are assessed for the change in PEFR and FEV1 at 30, 60 minutes, and 3, 6, 12 and 24 hours intervals.
Participants/Inclusion and exclusion criteria
80 patients with moderate to severe COPD following and exacerbated COPD due to respiratory tract infection and aged 15 to 70 years are included and patients with COPD-induced non-respiratory tract infection, history of asthma, allergic rhinitis or atopy, history of systemic corticosteroid of more than 1500 micrograms per day during the previous month, decrease in consciousness, known psychological disorder and inability to cooperate in the study are excluded from the study.
Intervention groups
The intervention group receives a budesonide nebulizer and the control group receives oral systemic steroid.
Main outcome variables
Change in peak expiratory flow rate, Change in FEV1 percentage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180523039800N1
Registration date:2018-10-30, 1397/08/08
Registration timing:registered_while_recruiting
Last update:2018-10-30, 1397/08/08
Update count:0
Registration date
2018-10-30, 1397/08/08
Registrant information
Name
Tina Mirrajei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 6136
Email address
tina_mirrajei@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-06, 1397/06/15
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Evaluation of the effect of budesonide nebulizer in patients with exacerbated COPD
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 15 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple
Randomization unit: Individual
Stratified randomization is not included
Randomization Tool: Random number table
Allocation concealment: The product and placebo are delivered to the physician with code numbers. Then the treatments will be prescribed to the patient based on a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients, researchers, health care persons including its physician and nurse, and the outcome evaluator are blinded until the end of the study. For this purpose, the patients are divided into an intervention and control group based on the randomization table and the treatment sample or placebo is sent to the physician with a code and the physician performs the treatments according to the product label.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Sixth floor, University central building, Qods St, Keshavarz St.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.108
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with (acute) exacerbation
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
Variation in FEV1 percentage
Timepoint
30 and 60 minutes and 3, 6, 12 and 24 hours later
Method of measurement
Spirometry
Intervention groups
1
Description
Intervention group: ُBudesonide nebulizer (inhaled steroid), Jaber ebne Hayyan Co., 0.5 mg, 3 times, every 30 minutes, and single dose oral placebo tablet
Category
Treatment - Drugs
2
Description
Control group: Oral prednisolone fort (oral systemic steroid), Abu Raihan Co., 50 mg, single dose, and placebo nebulizer, 3 times, every 30 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency services of Tehran University of Medical Sciences
Full name of responsible person
Tina Mirrajei
Street address
Imam Khomeini Hospital, Keshavarz St
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9010
Email
tina_mirrajei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elnaz Vahidi
Street address
Imam Khomeini Hospital, Keshavarz St
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9010
Email
evahidi62@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tina Mirrajei
Position
Medicine residency
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Imam Khomeini Hospital, Keshavarz St
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9010
Email
tina_mirrajei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elnaz Vahidi
Position
assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Imam Khomeini Hospital, Keshavarz St
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9010
Email
evahidi62@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tina Mirrajei
Position
Medicine residency
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Imam Khomeini Hospital, Keshavarz St
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6693 9010
Email
tina_mirrajei@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shared after the unidentifiable of the patients
When the data will become available and for how long
6 months after paper publication
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
In term of analysis the data related to study outcomes
From where data/document is obtainable
tina_mirrajei@yahoo.com
What processes are involved for a request to access data/document
The request will be assessed by research committee of Tehran University of Medical Sciences which will be taken around 3 months