Effectiveness and Safety of Inhaling Hypertonic Saline in Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
hypertonic saline
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Hypertonic saline, Quality of life, Dyspnoea.
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Functional exercise capacity
Secondary Outcome Measures
Dyspnoea
Full Information
NCT ID
NCT00639236
First Posted
March 14, 2008
Last Updated
March 19, 2008
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00639236
Brief Title
Effectiveness and Safety of Inhaling Hypertonic Saline in Patients With Chronic Obstructive Pulmonary Disease
Official Title
Effectiveness and Safety of Inhaling Hypertonic Saline in the Functional Exercise Capacity of Patients With Chronic Obstructive Pulmonary Disease: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Hypertonic saline, Quality of life, Dyspnoea.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
hypertonic saline
Intervention Description
inhaled hypertonic saline (at a dose of 5 ml of a 3% solution) three times a week, combined with a program of physical exercises.
Primary Outcome Measure Information:
Title
Functional exercise capacity
Time Frame
measured by the 6-minute walking distance (6MWD) test
Secondary Outcome Measure Information:
Title
Dyspnoea
Time Frame
measured by the Medical Research Council dyspnoea score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valderramas R Silvia, pHD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19245725
Citation
Valderramas SR, Atallah AN. Effectiveness and safety of hypertonic saline inhalation combined with exercise training in patients with chronic obstructive pulmonary disease: a randomized trial. Respir Care. 2009 Mar;54(3):327-33.
Results Reference
derived
Learn more about this trial
Effectiveness and Safety of Inhaling Hypertonic Saline in Patients With Chronic Obstructive Pulmonary Disease
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