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Effectiveness and Safety of Inhaling Hypertonic Saline in Patients With Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT00639236
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : March 20, 2008
Sponsor:
Information provided by:
Federal University of São Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: hypertonic saline Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2004
Actual Primary Completion Date : September 2004
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Intervention Details:
  • Other: hypertonic saline
    inhaled hypertonic saline (at a dose of 5 ml of a 3% solution) three times a week, combined with a program of physical exercises.

Outcome Measures
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Primary Outcome Measures :
  1. Functional exercise capacity [ Time Frame: measured by the 6-minute walking distance (6MWD) test ]

Secondary Outcome Measures :
  1. Dyspnoea [ Time Frame: measured by the Medical Research Council dyspnoea score ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639236


Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Valderramas R Silvia, pHD Federal University of Sao Paulo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Silvia Regina Valderramas, Evangelical Faculty of Paraná
ClinicalTrials.gov Identifier: NCT00639236    
Other Study ID Numbers: 017/04
017/04
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: March 20, 2008
Last Verified: March 2008
Keywords provided by Federal University of São Paulo:
COPD
Hypertonic saline
Quality of life
Dyspnoea.
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases