Protocol summary

Summary
This study desined to evaluate the effect of nebulized furosemide on dyspnea in chronic obstructive pulmonary disease. Inclusion criteria are patients with chronic obstructive pulmonary disease who had 40 year old or more. Exclusion criteria are advanced heart disease and lung fibrosis.90 patients with chronic obstructive pulmonary disease has been studied. These patients fall into two group of patients who receive salbuthamol and furosemide as nebulizer. One group receives 40 mg of furosemide as nebulizer for 7 minutes that the time needed for its nebulization. Other group receives 5 mg of salbuthamol as nebulizer for 5 minutes that the time is needed forb its nebulization.Both of them perform in one day. Dyspnea is assessed after each nebulization as primary end point.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201707126187N5
Registration date: 2017-08-25, 1396/06/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-25, 1396/06/03
Registrant information
Name
Mohammadi Saba
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
saba-ma@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between nebulized furosemide and salbuthamol on dyspnea improvment in chronic obstructive pulmonary disease patients reffered to shahid beheshti hospital
Public title
The effect of nebulized furosemide and salbuthamol on dyspnea in chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with chronic obstructive pulmonary disease based on their spirometry who had dyspnea according to class 3-5 mmrc Exclusion criteria: Advanced heart failure; Severe osteoarthritis; Inability to walking;Tracheal stenosis
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences Research Council
Street address
Ghotb Ravandi Blv
City
Kashan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
4078

Health conditions studied

1

Description of health condition studied
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
DYSPNEA
Timepoint
5 minute after nebulizer
Method of measurement
questionair

Secondary outcomes

1

Description
FEV1
Timepoint
15 minute after nebulizer
Method of measurement
spirometry

Intervention groups

1

Description
salbuthamol 2.5 mg
Category
Treatment - Drugs

2

Description
furosemide40 mg nebulizer
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan University of Medical Sciences
Full name of responsible person
Mohammadali Saba
Street address
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hamidi
Street address
Ghotb Ravandi Blv
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Mohammadali Saba
Position
Pulmonologist assisstant proffessor
Other areas of specialty/work
Street address
Ghotb Ravandi Blv
City
Kashan
Postal code
Phone
+98 36 13523
Fax
Email
mohammadali_saba@yahoo.comsaba-ma@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Mohammadali Saba
Position
Pulmonologist assisstant professor
Other areas of specialty/work
Street address
Ghotb Ravandi Blv
City
Kashan
Postal code
Phone
+98 36 13523
Fax
Email
mohammadali_saba@yahoo.comsaba-ma@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Mohammadali Saba
Position
Pulmonologist assisstant proffessor
Other areas of specialty/work
Street address
Ghotb Ravandi Blv shahid beheshti hospital
City
Kashan
Postal code
Phone
+98 36 13523
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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