Efficacy of Tiotropium compared with salmeterol in control of dynamic hyperinflation in patients with chronic obstructive pulmonary disease admitted to Imam Reza Hospital,Tabriz
In this study ,From first day of August 2011 to the end of March 2012 all patients referred to pulmonology clinic of Imam Reza Hospital with a diagnosis of COPD in the early stages (stages 1, 2) and after obtaining entry and exit criteria, were randomly divided into two groups with Tiotropium (only Tiotropium with 18 microgram per day via inhalation ) and the classical treatment group (salmeterol 50 microgram twice daily via inhalation ) are classified in the Shadow of a baseline spirometry to measure IC and RV / TLC with Body Box spirometry , and after two months of the treatment again and repeat the above results will be compared for dynamic hyperinflation. Total number of patients about 80 .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201098659N1
Registration date:2012-02-29, 1390/12/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-29, 1390/12/10
Registrant information
Name
Payam Salehirad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4901
Email address
salehip@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Science
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2012-09-26, 1391/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Tiotropium compared with salmeterol in control of dynamic hyperinflation in patients with chronic obstructive pulmonary disease admitted to Imam Reza Hospital,Tabriz
Public title
Effect of Tiotropium in Patients with Chronic Obstructive Pulmonary Diseases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:( Patient with early stages of COPD ;Men and Weman between 40 to 80 years old.)
Exclusion criteria:( Patients under 40 and above 80 ;Patients with a history of asthma ;lung Lobectomy history ;cystic fibrosis ;patients treated with inhaled or oral corticosteroids in the previous three months : patients with other diseases associated with clinical problems in their daily activities ; also to make it still more complications possible heart attack in the use of this drug is definitely ruled out, people with heart problems, will be excluded from the study.)
.
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:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Department of Research and Technology A productivity, Third Floor, Central Building No. 2 , Golgasht st. , Tabriz
City
Tabriz
Postal code
Approval date
2012-01-08, 1390/10/18
Ethics committee reference number
5/4/8134
Health conditions studied
1
Description of health condition studied
Chronic Obstructive Pulmonary Diseases
ICD-10 code
J40,J47
ICD-10 code description
Chronic Lower Respiratory Diseaes
Primary outcomes
1
Description
Dynamic Hyperinflation measurements
Timepoint
Before and Two months after completion of drug
Method of measurement
Study Of Lung Volumes using Spirometry
Secondary outcomes
empty
Intervention groups
1
Description
First Group therapy with Tiotropium
(only Tiotropium18 microgram per day via inhalation for two months)
Category
Treatment - Drugs
2
Description
Second Group : Classical therapy ( with Salmeterol 50 microgram twice daily via inhalation for two months )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Subspeciality Lung Disease Clinic of Imam Reza Hospital, Tabriz