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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00826163
Other study ID # BT-B-01-MG-14-5114
Secondary ID
Status Completed
Phase Phase 3
First received December 16, 2008
Last updated September 10, 2013
Start date January 2009
Est. completion date December 2009

Study information

Verified date September 2013
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- clinical diagnosis of COPD or asthma

- a ratio of prebronchodilator FEV1 to forced vital capacity (FVC) equal to or less than 0.70

- postbronchodilator FEV1 > or = 50% predicted

Exclusion Criteria:

- Exacerbation

- systemic corticosteroids

- DM, HIV and autoimmune disease

- immunosuppressive therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Budesonide
Inhaled budesonide 400 mcg twice a day for 2 weeks

Locations

Country Name City State
Thailand Kittipong Maneechotesuwan Bangkoknoi BKK

Sponsors (2)

Lead Sponsor Collaborator
Mahidol University National Science and Technology Development Agency, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sputum IL-8, IL-17 2 WEEKS No
Secondary The expression of NF-kappa B in sputum macrophages 2 WEEKS No
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