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Clinical Trials/NCT01664767
NCT01664767
Completed
Not Applicable

Placebo Controlled Study Evaluating the Modulatory Effects of Sulfur Thermal Water Inhalation on Superoxide Anion Levels in Exhaled Breath Condensate in COPD Patients

Università degli Studi di Ferrara1 site in 1 country40 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Sponsor
Università degli Studi di Ferrara
Enrollment
40
Locations
1
Primary Endpoint
Superoxide anion levels in exhaled breath condensate
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways characterized by fixed airflow obstruction, with important systemic co-morbidities. The obstruction is usually progressive and irreversible despite chronic therapy. Cigarette smoking is the major cause of this disease. COPD is an important cause of morbidity and mortality worldwide. Numerous studies have shown that oxidative stress plays a key role in the pathogenesis of COPD. In particular, the active metabolites of oxygen such as superoxide anion and the hydroxyl radical are unstable molecules that can trigger significant oxidative processes at the cellular level. These molecules can alter the extracellular matrix remodeling, cell respiration, cell proliferation, cellular repair and the immune response in the lung. All these events are key elements in the pathogenesis of COPD.

Currently available treatments for COPD (i.e. long-acting bronchodilators and inhaled corticosteroids) have not demonstrated a significant in vivo antioxidant effect. The thermal inhalation treatments are a therapeutic strategy used since many years in an empirical way in patients with COPD. Indeed, the evidence of effectiveness of spa treatment in patients with COPD are very limited.

The aim of this in vivo study is to evaluate the modulatory effects of sulfur thermal water inhalation on oxidant stress in the airways of stable COPD patients.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
June 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Università degli Studi di Ferrara
Responsible Party
Principal Investigator
Principal Investigator

Alberto Papi, MD

Professor

Università degli Studi di Ferrara

Eligibility Criteria

Inclusion Criteria

  • Forty stable moderate to severe COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2 and 3), according to international guidelines.
  • FEV1/FVC ratio post-bronchodilator \<70%
  • 30% \< FEV1 \< 80%

Exclusion Criteria

  • Concomitant lung diseases (e.g. lung cancer)
  • Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation.

Outcomes

Primary Outcomes

Superoxide anion levels in exhaled breath condensate

Time Frame: 12 days

Levels of superoxide anion levels will be measured at recruitment (day 0) and after 12 days of inhalation. Changes between day 12 and day 0 will be evaluated.

Secondary Outcomes

  • Superoxide anion levels in exhaled breath condensate(42 day)
  • Inflammatory cell counts in induced sputum(42 days)
  • Clinical outcomes(42 days)

Study Sites (1)

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