Effects of Sulfur Thermal Water Inhalation on Airway Oxidative Stress in COPD Patients
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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 |
- 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.
- 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.
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2011 |
| Estimated 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 |
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| Contact: Alberto Papi, MD | +390532236908 | ppa@unife.it |
| Contact: Marco Contoli, MD | +390532236908 | ctm@unife.it |
| Italy | |
| Research Centre on Asthma and COPD, University of Ferrara | Recruiting |
| Ferrara, Italy, 44121 | |
More Information
No publications provided
| 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: | April 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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013