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

NCT01664767 | Completed

• 1 other identifier: RTUNIFE01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Thermal water; Oxidative stress; Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Superoxide anion levels in exhaled breath condensate

  42 day

• Inflammatory cell counts in induced sputum

  42 days

• Clinical outcomes

  42 days

Study Arms (2)

Thermal water inhalation

EXPERIMENTAL

Patients will perform 12 days of sulfur thermal water inhalation

Other: Sulfur Thermal water

Isotonic saline inhalation

PLACEBO COMPARATOR

Patients will perform 12 days of isotonic saline inhalation

Other: Placebo

Interventions

Sulfur Thermal water OTHER

Thermal water inhalation

Placebo OTHER

Isotonic saline inhalation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• % \< FEV1 \< 80%

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead
• Terme di Riolo Spa: collaborator

Study Sites (1)

Research Centre on Asthma and COPD, University of Ferrara

Ferrara, 44121, Italy

Location

Related Publications (1)

• 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.

  PMID: 24453924 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: August 14, 2012
• Study Start: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 30, 2013

Record last verified: 2013-12

Locations

IT (1)