Evaluation of therapeutic effect of Tiotropium Bromide in early stages of chronic obstructive pulmonary disease in patients of subspecialty clinics of Isfahan university of medical science in 2018 - 2019
Evaluation of therapeutic effect of Tiotropium Bromide in early stages of chronic obstructive pulmonary disease in patients of subspecialty clinics of Isfahan university of medical science in 2018 - 2019
Design
Randomized, controlled, parallel, double-blind clinical trial, phase 3.
Sample size is 46 in each group. Randomization by software.
Settings and conduct
this research will be hold in Isfahan university of medical sciences clinics in double-blinded (physician and patient) way.
Participants/Inclusion and exclusion criteria
1. age 40 - 85 years
2. Hx of COPD GOLD stage 1 ,2
3. FEV1/FVC ratio less than 0.7 after bronchodilator usage.
Intervention groups
Intervention group will receive 18 microgram tiotropium bromide inhlaer once daily for 6 months. placebo group will recieve placebo with same shape at the same times. Placebo will be made by pharmacology school. Medications will have no label and none of physician or patients know the type of drug. In next visits clinical situation and spirometry values will be evaluated in one, 3 and 6 months after first visit.
Main outcome variables
FEV1 - %FEV1 - FVC - FEV1/FVC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190524043684N1
Registration date:2019-10-13, 1398/07/21
Registration timing:prospective
Last update:2019-10-13, 1398/07/21
Update count:0
Registration date
2019-10-13, 1398/07/21
Registrant information
Name
Hazhir Moradi Khaniabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 5089
Email address
moradi.hazhir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of Tiotropium Bromide in early stages of chronic obstructive pulmonary disease in patients of subspecialty clinics of Isfahan university of medical science in 2018 - 2019
Public title
Evaluation of therapeutic effect of Tiotropium Bromide in early stages of chronic obstructive pulmonary disease in patients of subspecialty clinics of Isfahan university of medical science in 2018 - 201
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 40 - 80 years
History of COPD stage GOLD 1 , 2
FEV1 to FVC ratio less than 0.7 after bronchodilator use
Exclusion criteria:
Not signing informed consent
Age
From 40 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
patients allocated in two groups of intervention and control randomly by randomizer.org randomization software to produce a random sequence. After allocating a number based on random sequence, even numbers will be assigned to group A and odd numbers to group B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo will be used in this study. The placebo is completely similar in appearance to the main drug. Medication and placebo are indicated by the letters A and B. The patient, clinical caregiver, and outcome assessor will not know how the letters A and B are assigned to the drug and placebo. Drug and placebo are given by the researcher to the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences