1. Home
  2. Approved trials
  3. » فارسی

Comparison the effect of salbutamol via nebulizer, spray with and without spacer on pulmonary function in Chronic Obstructive Pulmonary Disease (COPD)

Protocol summary

Study aim
Comparison the effect of salbutamol via nebulizer, spray with and without spacer on pulmonary function in chronic obstructive pulmonary disease (COPD)
Design
The clinical trial with parallel and randomized groups with time series design and measurements will be made at reasonable intervals (based on scientific texts) and consecutively.
Settings and conduct
The research area will be the Shohada hospitals in Qaen. In this clinical trial study, 66 patients with COPD will be selected and randomly allocated in three groups of Sprays, Spacer, and Nebulizer by the method of 6-permutation blocks. Before the intervention, lung function indicators will be measured using a spirometry device, the respiratory rate, and the percentage of oxygen saturation of the blood using a pulse oximetry device. Then patients will be given in one group Salbutamol by spray, patients in the second group Salbutamol through a spacer, and the third group Salbutamol through nebulizer. Then, 15, 30, 60, and 90 minutes later, spirometry will be performed again and respiratory indicators will be determined. This will be done on two consecutive days.
Participants/Inclusion and exclusion criteria
Patients with COPD between the ages of 40 and 75 who are alert and able to speak and communicate and do not have underlying diseases such as diabetes and kidney and heart failure, etc., and the spirometry test has a ratio of 0.7> FEV1 / FVC.
Intervention groups
Then patients in first group will be given Salbutamol by spray, patients in the second group Salbutamol through Spacer and the third group Salbutamol through Nebulizer.
Main outcome variables
Lung function "lung volumes and capacities"

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200228046634N1
Registration date: 2021-05-15, 1400/02/25
Registration timing: retrospective

Last update: 2021-05-15, 1400/02/25
Update count: 0
Registration date
2021-05-15, 1400/02/25
Registrant information
Name
Maryam Derogar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3249 6362
Email address
derogar.m.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of salbutamol via nebulizer, spray with and without spacer on pulmonary function in Chronic Obstructive Pulmonary Disease (COPD)
Public title
The effect of salbutamol on pulmonary volumes and capacities
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in research Abnormal spirometry test including 0.7≥ FEV1/FVC ratio Age of 40-75 years old Physical ability to perform spirometry maneuvers Lack of pregnancy With body mass index between 18.5 - 25 Stages 1-4 of the disease based on GOLD criteria No specific intervention related to COPD or other possible diseases other than routine treatments Having awareness, the power of speech and communication Having a stable physiological state to answer questions No spirometry contraindications (uncontrolled blood pressure, infectious respiratory infection, active hemoptysis, recent eye or ear surgery, rupture of the tympanic membrane, recent history of CVA or pulmonary embolism, history of myocardial infarction or unstable angina in the last 6 weeks)
Exclusion criteria:
Severely ill patients with COPD exacerbation with loss of consciousness or need for intubation Patients with comorbidity disorders such as heart failure, kidney, liver and diabetes Asthma, pneumonia and severe respiratory failure with cyanosis and confusion
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
The research units will be selected as available in terms of study entry criteria and will be randomly assigned to the three groups of sprays, spacer and nebulizer using triple permutation blocks. In this method, if we consider the spray group A, the spacer group B, and the nebulizer group C, the six possible states in the triple blocks will be ABC-BAC-BCA-ACB-CAB-CBA, Each of these blocks will be assigned a number(We determine the number assigned to each block and it starts from 1). These numbers will be poured into a container and one of these numbers will be removed randomly by drawing lots at the beginning of sampling.Based on the selected number and the corresponding block, patients will be included in the study.After the arrival of the first three patients according to the designated block, a number was randomly removed from the container and sampling will continue.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study has a time series design

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Science
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabadوووو
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2020-01-27, 1398/11/07
Ethics committee reference number
IR.GMU.REC.1398.149

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease (COPD)
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
The pulmonary volumes and capacities
Timepoint
The Measurement of pulmonary volumes and capacities at the beginning of the study and 15, 30, 60 and 90 minutes after the beginning of the intervention
Method of measurement
Perform the spirometry test in two consecutive days

2

Description
The respiratory indicators
Timepoint
At the beginning of the study and 15, 30, 60 and 90 minutes after the beginning of the intervention
Method of measurement
The Respiratory Rate by counting the number of chest ups and downs and the percentage of oxygen saturation of the blood using the pulseoximetry device

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group: receiving 200 micro grams of Salbutamol Equivalent to 2 puffs via Salbutamol spray under the Ventalex brand two minutes apart at a time.
Category
Treatment - Drugs

2

Description
The intervention group: receiving 200 micro grams of Salbutamol Equivalent to 2 puffs through Salbutamol spray under the Ventalex brand through spacer manufactured by Spadana Medical Technology Company two minutes apart at a time..
Category
Treatment - Drugs

3

Description
Intervention group: receiving 2.5 mg of Salbutamol solution of the Astalin brand through nebulizer type of ultrasound made by Rastak Medical Technology Company in one turn .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Qaen Shohada hospital
Full name of responsible person
Dr. Mohammad Reza Arefifar
Street address
Shafa Street, Qaen Shohada hospital
City
Qaen
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3162 8000
Email
public_r@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Derogar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 4, Boostan 1Ave, Baharesttan Blvd, Farmandari Town
City
Gaen
Province
South Khorasan
Postal code
9861411957
Phone
+98 56 3249 6362
Email
dm.derogar72@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Kokab Basiri Moghaddam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
Email
K.basiri@gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Derogar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan 3, Farmandari Town
City
Qaen
Province
South Khorasan
Postal code
9861411957
Phone
+98 56 3249 6362
Fax
Email
derogar.m.stu@gmu.ac.ir

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
Potential data will be shared after unidentifiable individuals.
When the data will become available and for how long
Get started 8 months after the publication of results
To whom data/document is available
The researcher on academic institutions
Under which criteria data/document could be used
The information should not be changed.
From where data/document is obtainable
E-mail Maryam Derogar: dm.derogar72@gmail.com
What processes are involved for a request to access data/document
The E-mail to the given address and provide sufficient and acceptable information. Information will be given if data is acceptable.
Comments
Loading...