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

This study has been completed.
Sponsor:
Collaborator:
Terme di Riolo Spa
Information provided by (Responsible Party):
Alberto Papi, MD, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT01664767
First received: August 10, 2012
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
Other: Sulfur Thermal water
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Placebo Controlled Study Evaluating the Modulatory Effects of Sulfur Thermal Water Inhalation on Superoxide Anion Levels in Exhaled Breath Condensate in COPD Patients

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Ferrara:

Primary Outcome Measures:
  • Superoxide anion levels in exhaled breath condensate [ Time Frame: 12 days ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Superoxide anion levels in exhaled breath condensate [ Time Frame: 42 day ] [ Designated as safety issue: No ]
    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.

  • Inflammatory cell counts in induced sputum [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    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.

  • Clinical outcomes [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: November 2011
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01664767

Locations
Italy
Research Centre on Asthma and COPD, University of Ferrara
Ferrara, Italy, 44121
Sponsors and Collaborators
Università degli Studi di Ferrara
Terme di Riolo Spa
  More Information

No publications provided by Università degli Studi di Ferrara

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alberto Papi, MD, Professor, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT01664767     History of Changes
Other Study ID Numbers: RTUNIFE01
Study First Received: August 10, 2012
Last Updated: December 27, 2013
Health Authority: Italy: National Institute of Health

Keywords provided by Università degli Studi di Ferrara:
COPD
Thermal water
Oxidative stress
Inflammation

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014