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

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Other: Placebo; Other: Sulfur Thermal water

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44121
    • Research Centre on Asthma and COPD, University of Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermal water inhalation; Patients will perform 12 days of sulfur thermal water inhalation	Other: Sulfur Thermal water
Placebo Comparator: Isotonic saline inhalation; Patients will perform 12 days of isotonic saline inhalation	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superoxide anion levels in exhaled breath condensate	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.	12 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superoxide anion levels in exhaled breath condensate	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.	42 day
Inflammatory cell counts in induced sputum	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.	42 days
Clinical outcomes	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.	42 days

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara
• Collaborators: Terme di Riolo Spa

Publications and helpful links

General Publications

• Contoli M, Gnesini G, Forini G, Marku B, Pauletti A, Padovani A, Casolari P, Taurino L, Ferraro A, Chicca M, Ciaccia A, Papi A, Pinamonti S. Reducing agents decrease the oxidative burst and improve clinical outcomes in COPD patients: a randomised controlled trial on the effects of sulphurous thermal water inhalation. ScientificWorldJournal. 2013 Dec 23;2013:927835. doi: 10.1155/2013/927835. eCollection 2013.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 13, 2012
• First Posted (Estimate): August 14, 2012

Study Record Updates

• Last Update Posted (Estimate): December 30, 2013
• Last Update Submitted That Met QC Criteria: December 27, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Oxidative stress; Inflammation; COPD; Thermal water
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: RTUNIFE01