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Is the function of HDL cholesterol impaired in COPD and whether inhaled steroids can improve HDL function?

Impact of systemic inflammation and oxidative stress on HDL function in the natural course of Chronic Obstructive Pulmonary Disease - A hospital based double blinded randomized placebo controlled study. - ISCOL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/03/006773
Enrollment
80
Registered
2016-03-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Severe exacerbation of Chronic Obstructive Pulmonary Disease requiring hospitalization.

Interventions

Intervention1: Inhaled budesonide plus standard treatment for COPD: Inhaled budesonide 400 micrograms twice daily for eight weeks along with standard treatment for COPD. Control Intervention1: Placebo

Sponsors

PSG Institute of Medical Sciences and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 40 years and above. Smoking history with more than 10 pack years. Physician diagnosed severe exacerbation of COPD requiring hospitalization. Willing to participate in the study adhering to its protocol.

Exclusion criteria

Exclusion criteria: History suggestive of asthma. History of past or coexisting malignancy, connective tissue disorders and other chronic inflammatory disorders. Coexisting poorly controlled diabetes mellitus (HbA1C > 8.5%), pneumonia and active tuberculosis. Subjects requiring ICU stay with or without life support for management of severe exacerbation of COPD. Mental status not competent enough to consent for the study.

Design outcomes

Primary

MeasureTime frame
Changes in lipids level, systemic inflammation oxidative stress and anti-inflammatory function of HDL during acute exacerbation of COPD and recovery to stable state.Timepoint: eight weeks

Secondary

MeasureTime frame
dynamics of PON1 activity during AECOPD and after recovery to stable state.Timepoint: eight weeks;impact of inhaled corticosteroids on the systemic inflammation, oxidative stress and HDL function in COPD.Timepoint: eight weeks;Influence of PON1 activity with lipid peroxidation, systemic inflammation oxidative stress and HDL function in COPD.Timepoint: eight weeks

Countries

India

Contacts

Public ContactRamalingam Sankaran

PSG Institute of Medical Sciences and Research

drrampsg@gmail.com9894618450

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026