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

- 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.
- Functional exercise capacity [ Time Frame: measured by the 6-minute walking distance (6MWD) test ]
- Dyspnoea [ Time Frame: measured by the Medical Research Council dyspnoea score ]

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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 |
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

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
Principal Investigator: | Valderramas R Silvia, pHD | Federal University of Sao Paulo |
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 |
COPD Hypertonic saline Quality of life Dyspnoea. |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |