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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20150210001 |
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Date of registration:
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10/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Aerobidol® Inhaler on pulmonary function in COPD patients
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Scientific title:
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Effects of Aerobidol® Inhaler on pulmonary function test parameters compared with Berodual® in COPD patients |
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Date of first enrolment:
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09/02/2015 |
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Target sample size:
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Recruitment status: |
Pending (Not yet recruiting) |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20150210001 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Kamon
Kawkitinarong |
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Address:
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Chest Unit, second floor, Sawad-Lom building, 1870 Rama IV Rd., Pathumwan
10330
Bangkok
Thailand |
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Telephone:
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0813111501 |
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Email:
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kamonkaw@hotmail.com |
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Affiliation:
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Department of Medicine Faculty of Medicine, Chulalongkorn University |
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Name:
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Kamon
Kawkitinarong |
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Address:
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Bangkok
10330
Thailand |
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Telephone:
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0813111501 |
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Email:
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kamonkaw@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients aged more than 40 years, smoking more than 10 packyears who diagnosed with COPD by spirometry (post bronchodilator FEV1/FVC less than 70%)
Exclusion criteria: Patients who cannot perform body plethysmography
COPD patients who have medical disease such as lung cancer, bronchiectasis, severe tracheobronchomalacia
Patients who refuse to join the study
Age minimum:
40 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aerobidol
COPD
pulmonary function
FEV1
RV
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chronic obstructive pulmonary disease
Aerobidol
COPD
pulmonary function
FEV1
RV
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Intervention(s)
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Aerobidol Inhaler,Berodual
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Aerobidol Inhaler is a trade name of locally made product which have dose and components similar to Berodual.,Berodual is a trade name of original product bronchodilator; in one puff of metered dose inhaler composed of ipratropium bromide 20 micrograms and fenoterol hydrobromide 50 micrograms.
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Experimental Drug,Active Comparator Drug
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Primary Outcome(s)
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FEV1, FVC, IC, RV, TLC 2 (pre-,post-) body plethysmography
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Secondary Outcome(s)
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satisfaction score, side effects 1 questionnaire
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Secondary ID(s)
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Aeocare-protocol-cop
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Source(s) of Monetary Support
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AeroCare Co.,Ltd
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Ethics review
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Status: Submitted, pending
Approval date:
Contact:
Faculty of Medicine Review Board of Ethic Committee
02-2564493 Ext. 14 or 15
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Results
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Results available:
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Date Posted:
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Date Completed:
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30/10/2015 |
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URL:
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