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History of Changes for Study: NCT00639236
Effectiveness and Safety of Inhaling Hypertonic Saline in Patients With Chronic Obstructive Pulmonary Disease
Latest version (submitted March 19, 2008) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 19, 2008 None (earliest Version on record)
Comparison Format:

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Study NCT00639236
Submitted Date:  March 19, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: 017/04
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
Secondary IDs: 017/04
Open or close this module Study Status
Record Verification: March 2008
Overall Status: Completed
Study Start: May 2004
Primary Completion: September 2004 [Actual]
Study Completion: November 2006 [Actual]
First Submitted: March 14, 2008
First Submitted that
Met QC Criteria:
March 19, 2008
First Posted: March 20, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 19, 2008
Last Update Posted: March 20, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Federal University of São Paulo
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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.
Open or close this module Conditions
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Hypertonic saline
Quality of life
Dyspnoea.
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 68 [Actual]
Open or close this module Arms and Interventions
Intervention Details:
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.
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Study Officials: Valderramas R Silvia, pHD
Principal Investigator
Federal University of Sao Paulo
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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