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

NCT ID: NCT01664767

Last Updated: 2013-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thermal water inhalation

Patients will perform 12 days of sulfur thermal water inhalation

Group Type: EXPERIMENTAL

Sulfur Thermal water

Intervention Type: OTHER

Isotonic saline inhalation

Patients will perform 12 days of isotonic saline inhalation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Sulfur Thermal water

Intervention Type: OTHER

Placebo

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terme di Riolo Spa

UNKNOWN

Sponsor Role: collaborator

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Alberto Papi, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Research Centre on Asthma and COPD, University of Ferrara

Ferrara, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 24453924 (View on PubMed)

Other Identifiers

RTUNIFE01

Identifier Type: -

Identifier Source: org_study_id