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

NCT00639236 | Completed Phase 4 DMC

• 1 other identifier: 017/04
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Hypertonic saline; Quality of life; Dyspnoea.

Outcome Measures

Primary Outcomes (1)

• Functional exercise capacity

  measured by the 6-minute walking distance (6MWD) test

Secondary Outcomes (1)

• Dyspnoea

  measured by the Medical Research Council dyspnoea score

Interventions

hypertonic saline OTHER

inhaled hypertonic saline (at a dose of 5 ml of a 3% solution) three times a week, combined with a program of physical exercises.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Related Publications (1)

• 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.

  PMID: 19245725 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Valderramas R Silvia, pHD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 20, 2008
• Study Start: May 1, 2004
• Primary Completion: September 1, 2004
• Study Completion: November 1, 2006
• Last Updated: March 20, 2008

Record last verified: 2008-03