Sodium chloride

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

other: Publication

Adequacy of study:

supporting study

Study period:

2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The publication has sufficient information for the interpretation of results.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Inhaled hypertonic saline produces small increases in lung function in patients with cystic fibrosis

Author:

Elkins et al.

Year:

2006

Bibliographic source:

The Journal of Pediatrics July 2006

Materials and methods

Type of study / information:

Long-term use of inhaled hypertonic saline solution improve pulmonary function in people with cystic fibrosis.

Endpoint addressed:

not applicable

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

None

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium chloride

EC Number:

231-598-3

EC Name:

Sodium chloride

Cas Number:

7647-14-5

Molecular formula:

ClNa

IUPAC Name:

sodium chloride

Details on test material:

- Name of test material (as cited in study report): Hypertonic Saline Solution (HS)

Method

Ethical approval:

not specified

Details on study design:

Patients were randomly assigned to inhale 4 mL of either 7% hypertonic saline solution (HS) or 0.9% (control) saline solution twice daily for 48 weeks, with quinine sulfate (0.25 mg/mL) added to each solution to mask the taste. A bronchodilator was given before each dose, and other standard therapies were continued during the trial.

Exposure assessment:

not specified

Details on exposure:

The linear rate of change in pulmonary function, reflected by the forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and forced expiratory flow at 25% to 75% of FVC, during the 48 weeks of treatment.

Results and discussion

Results:

The rate of change in pulmonary function did not differ significantly between groups (P .79). However, the absolute difference in pulmonary function between groups was significant (P .03) when averaged across all post-randomization visits in the 48-week treatment period. As compared with
the control group, the HS group had significantly higher FVC (by 82 mL; 95% confidence interval, 12 to 153) and FEV1 (by 68 mL; 95% confidence interval, 3 to 132) values but similar values of forced expiratory flow at 25% to 75% of FVC. The HS group also had significantly fewer pulmonary exacerbations (relative reduction, 56%; P.02) and a significantly higher percentage of patients without exacerbations (76% vs 62%, P .03, number needed to treat 8). HS was not associated with worsening bacterial infection or inflammation.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Hypertonic saline solution preceded by a bronchodilator is an inexpensive, safe, and effective additional therapy for patients with CF.

Executive summary:

Patients were randomly assigned to inhale 4 mL of either 7% hypertonic saline solution (HS) or 0.9% (control) saline solution twice daily for 48 weeks, with quinine sulfate (0.25 mg/mL) added to each solution to mask the taste. A bronchodilator was given before each dose, and other standard therapies were continued during the trial.

The linear rate of change in pulmonary function, reflected by the forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and forced expiratory flow at 25% to 75% of FVC, during the 48 weeks of treatment.

The rate of change in pulmonary function did not differ significantly between groups (P .79). However, the absolute difference in pulmonary function between groups was significant (P .03) when averaged across all post-randomization visits in the 48-week treatment period. As compared with

the control group, the HS group had significantly higher FVC (by 82 mL; 95% confidence interval, 12 to 153) and FEV1 (by 68 mL; 95% confidence interval, 3 to 132) values but similar values of forced expiratory flow at 25% to 75% of FVC. The HS group also had significantly fewer pulmonary exacerbations (relative reduction, 56%; P.02) and a significantly higher percentage of patients without exacerbations (76% vs 62%, P .03, number needed to treat 8). HS was not associated with worsening bacterial infection or inflammation.

Hypertonic saline solution preceded by a bronchodilator is an inexpensive, safe, and effective additional therapy for patients with CF.