Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effectiveness and Safety of Inhaling Hypertonic Saline in the Functional Exercise Capacity of Patients With Chronic Obstructive Pulmonary Disease: a Randomized Trial
Verified date | March 2008 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | November 2006 |
Est. primary completion date | September 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients with COPD diagnosis based on clinical findings and spirometry (FEV1 < 60% predict) according to American Thoracic Society20 clinically stable for at least the last month - aged between 40 and 75 years old - ex-smokers - without severe and/or unstable heart disease or any other pathologic conditions that could impair physical activities (e.g., cerebrovascular diseases and rheumatism), were included. - Respiratory medication was permitted, prior and throughout the duration of the study, such as bronchodilators and corticosteroids. Exclusion Criteria: - Patients with unstable lung disease (as evidenced by the administration of intravenous antibiotics for four weeks before screening) - evidence of reactive airways (FEV1 = 20 percent response to bronchodilatation or clinical diagnosis of asthma) were excluded |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional exercise capacity | measured by the 6-minute walking distance (6MWD) test | Yes | |
Secondary | Dyspnoea | measured by the Medical Research Council dyspnoea score | Yes |
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