Clinical trial NCT00639236: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Hypertonic saline
Quality of life
Dyspnoea.
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-03-20
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional exercise capacity
timeFrame: measured by the 6-minute walking distance (6MWD) test
Secondary outcomes:
measure: Dyspnoea
timeFrame: measured by the Medical Research Council dyspnoea score
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Valderramas R Silvia, pHD
role: PRINCIPAL_INVESTIGATOR
References:
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.