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Completed

NCT Number: NCT01664767

Effects of Sulfur Thermal Water Inhalation on Airway Oxidative Stress in COPD Patients

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Centre on Asthma and COPD, University of Ferrara

Ferrara, 44121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Sulfur Thermal water

Other

Placebo

Other

Primary outcomes

  1. 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

  1. Superoxide anion levels in exhaled breath condensate

    Time frame: 42 day

    Levels of superoxide anion will be measured at recruitment (day 0), after 12 days of inhalation (day 12) and one month after the last day oh inhalation (day 42). Changes between day 42, day 12 and day 0 will be evaluated.

  2. Inflammatory cell counts in induced sputum

    Time frame: 42 days

    Inflammatory cell counts in induced sputum will be measured at recruitment (day 0), after 12 days of inhalation (day 12) and one month after the last day of inhalation (day 42). Changes between day 42, day 12 and day 0 will be evaluated.

  3. Clinical outcomes

    Time frame: 42 days

    Spirometry and the impact of COPD on patient quality of life (performed by the COPD Assessment Test (CAT)) will be measured at recruitment (day 0), after 12 days of inhalation (day 12) and one month after the last day of inhalation (day 42). Changes between day 42, day 12 and day 0 will be evaluated.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Collaborators

  • Terme di Riolo Spa

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 14, 2012
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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