Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT00826163

BT-B-01-MG-14-5114

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

stable COPD

Active Comparator group

Description:

Postbronchodilator FEV1\> or = 50% predicted

Treatment:

Drug: Budesonide

Asthma

Sham Comparator group

Description:

Postbronchodilator FEV1 \> or = 50% predicted

Treatment:

Drug: Budesonide