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Sponsored by: |
Federal University of São Paulo |
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Information provided by: | Federal University of São Paulo |
ClinicalTrials.gov Identifier: | NCT00639236 |
The use of inhaled hypertonic saline has been extensively documented in asthma, bronchiectasis, cystic fibrosis and COPD as method of bronchial challenge and sputum induction, but studies that evaluated others endpoints are required. The objective of this study was to analyse the effects of inhaling hypertonic saline compared with placebo with respect to functional exercise capacity, dyspnoea and quality of life. In a double-blind randomised parallel placebo-controlled trial, conducted at the Clínicas Integradas of the Evangelical Faculty of Paraná,sixty-eight patients (age 67 ± 6.5 years; FEV1 38.9 ± 16.2 predicted) were randomised to inhale 3% hypertonic saline (n=34) or placebo (n=34), combined with a program of exercise, three times a week, for 8-weeks.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease |
Other: hypertonic saline |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effectiveness and Safety of Inhaling Hypertonic Saline in the Functional Exercise Capacity of Patients With Chronic Obstructive Pulmonary Disease: a Randomized Trial |
Enrollment: | 68 |
Study Start Date: | May 2004 |
Study Completion Date: | November 2006 |
Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
Background: The use of inhaled hypertonic saline has been extensively documented in asthma, bronchiectasis, cystic fibrosis and COPD as method of bronchial challenge and sputum induction, but studies that evaluated others endpoints are required. Objective: To analyse the effects of inhaling hypertonic saline compared with placebo with respect to functional exercise capacity, dyspnoea and quality of life. Design and Setting: This was a double-blind randomised parallel placebo-controlled trial, conducted at the Clínicas Integradas of the Evangelical Faculty of Paraná. Methods: sixty-eight patients (age 67 ± 6.5 years; FEV1 38.9 ± 16.2 predicted) were randomised to inhale 3% hypertonic saline (n=34) or placebo (n=34), combined with a program of exercise, three times a week, for 8-weeks. Results: After the 8-weeks the treatment period, both groups showed significant changes in functional exercise capacity (p<0,001), dyspnoea (p<0,001) and quality of life. When compared both groups, there was a significant improvement in placebo group in functional exercise capacity (p<0,001). Conclusion: the present study concluded that inhaling HS reduces the functional capacity, compared to placebo and being associated with the appearance of coughs and bronchial spasms.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Evangelical Faculty of Paraná ( Silvia Regina Valderramas ) |
Study ID Numbers: | 017/04, 017/04 |
Study First Received: | March 14, 2008 |
Last Updated: | March 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00639236 History of Changes |
Health Authority: | Brazil: Ministry of Health |
COPD Hypertonic saline Quality of life Dyspnoea. |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Quality of Life Dyspnea Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |