Status:
COMPLETED
Effectiveness and Safety of Inhaling Hypertonic Saline in Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Federal University of São Paulo
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
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 evaluat...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00639236
Start Date
May 1 2004
End Date
November 1 2006
Last Update
March 20 2008
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