Completed

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

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What is being tested

Sulfur Thermal water

+ Placebo

Other
Who is being recruted

Chronic Disease+6

+ Lung Diseases

+ Lung Diseases, Obstructive

From 50 to 80 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: November 2011
See protocol details

Summary

Principal SponsorUniversità degli Studi di Ferrara
Last updated: December 30, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2011

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversità degli Studi di Ferrara
Last updated: December 30, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesInflammationPulmonary Disease, Chronic Obstructive

Criteria

3 inclusion criteria required to participate
30% < FEV1 < 80%

FEV1/FVC ratio post-bronchodilator < 70%

Forty stable moderate to severe COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2 and 3), according to international guidelines

4 exclusion criteria prevent from participating
Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation

Asthma

Atopy

Concomitant lung diseases (e.g. lung cancer)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Patients will perform 12 days of sulfur thermal water inhalation

Group II

Placebo
Patients will perform 12 days of isotonic saline inhalation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Research Centre on Asthma and COPD, University of Ferrara

Ferrara, ItalyOpen Research Centre on Asthma and COPD, University of Ferrara in Google Maps
CompletedOne Study Center