The purpose of this study was to determine the effect of salmeterol, tiotropium bromide and its combination in patients with acute exacerbation of COPD.
Design
The randomized clinical trials with single blinded and parallel design in three group.
Settings and conduct
This double-blind study will be conducted on patients with acute exacerbated COPD referred to the Emergency Department of Shahid Beheshti Hospital. Participants in the study will be placed randomly divided into three groups: salmeterol spray, tiotropium bromide capsule, Combination of salmeterol spray and tiotropium bromide capsule.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 35 years and Patients reporting at least 10 packets of cigarette smoking.
Exclusion criteria: Severe associated comorbidities (cardiac and renal) and Patients with prostate hypertrophy and closed glaucoma.
Intervention groups
For intervention group 1 salmeterol spray, internvention 2 an inhalable capsule of tiotropium bromide and intervention 3 a combination will be administered separately for 15 days during admission.
Main outcome variables
Arterial blood gas; COPD severity; dyspnea
General information
Reason for update
Acronym
COPD
IRCT registration information
IRCT registration number:IRCT20190123042466N1
Registration date:2019-04-07, 1398/01/18
Registration timing:prospective
Last update:2019-04-07, 1398/01/18
Update count:0
Registration date
2019-04-07, 1398/01/18
Registrant information
Name
Omid Otroshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
otroshi-om@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-04-25, 1398/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Salmetrol, Tiotropium, and their Combination in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Public title
The Effect of Salmetrol, Tiotropium, and their Combination in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute exacerbation of COPD
Age over 35 years
Spirometry or previous histories consistent with chronic obstructive pulmonary disease
Patients reporting at least 10 packets of cigarette smoking
Exclusion criteria:
Acute coronary syndrome
Severe associated comorbidities (cardiac and renal)
Patients with a recent history of myocardial infarction
Patients with prostate hypertrophy and closed glaucoma
Patients with allergic rhinitis or atopy
Age
From 35 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into three groups of 36 people using a computer-generated random numbers and through randomized block design
Blinding (investigator's opinion)
Double blinded
Blinding description
The person analyzing the study data would not know who was receiving the which drug until the end of the data analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan University of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2018-12-24, 1397/10/03
Ethics committee reference number
IR.Kaums.REC.1397.085
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
Dyspnea in daily living
Timepoint
At the beginning of the study and 15 days after the start of treatment
Method of measurement
The modified Medical Research Council scale
2
Description
Severity of chronic obstructive pulmonary disease
Timepoint
At the beginning of the study and 15 days after the start of treatment
Method of measurement
Chronic obstructive pulmonary disease assessment Test
Secondary outcomes
1
Description
Arterial blood gas parameters
Timepoint
At the beginning of the study and 15 days after the start of treatment
Method of measurement
Arterial blood gases
Intervention groups
1
Description
Intervention group: Salmeterol spray will be used three times a day with a dose of 25 micrograms for 15 days.
Category
Treatment - Drugs
2
Description
Intervention group: A thiotropium bromide capsule is given by mouth using Handihaler as an inhaler form twice a day with a dose of 18 micrograms for 15 days
Category
Treatment - Drugs
3
Description
Intervention group: Combination of salmeterol spray with a dose of 25 micrograms twice a day and a thiotropium bromide capsule at a dose of 18 micrograms once a day for 15 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Mohammad Ali Saba
Street address
Ghotbe Ravandi Boulevard, Kashan University of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
+98 31 5554 0022
Email
Saba-ma@kaums.ac.ir
Web page address
http://kaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hmidreza Banafshe
Street address
Ghotbe Ravandi Boulevard, Kashan University of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
+98 31 5554 0022
Email
Saba-ma@kaums.ac.ir
Web page address
http://kaums.ac.ir/
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
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
Kashan University of Medical Sciences
Full name of responsible person
MohammadAli Saba
Position
Pulmonologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ghotbe Ravandi Boulevard, Kashan University of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
+98 31 5554 0022
Email
aba-ma@kaums.ac.ir
Web page address
http://kaums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
MohammadAli Saba
Position
Pulmonologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ghotbe Ravandi Boulevard, Kashan University of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
+98 31 5554 0022
Email
Saba-ma@kaums.ac.ir
Web page address
http://kaums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
MohammadAli Saba
Position
Pulmonologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ghotbe Ravandi Boulevard, Kashan University of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
+98 31 5554 0022
Email
Saba-ma@kaums.ac.ir
Web page address
http://kaums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is done, After the study is completed
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available