Hypertonic saline in primary ciliary dyskinesia: a pilot study

Phase 4

Completed

Conditions: 10024970
Kartagener syndrome
Primary ciliary dyskinesia
10038686
10004018

Registration Number: NL-OMON40843

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

o Diagnosis of primary ciliary dyskinesia
o * 18 years of age
o Capable of performing lung function tests.
o The forced expiratory volume in one second (FEV1), measured at screening, has to be within 10 % of the best value obtained during the previous six months and at least 40% of the predicted value for height, age and sex.

Exclusion Criteria

o Smoking
o FEV1 < 40 %.
o Use of Pulmozyme or other mucolytics or non-routine antibiotics in the previous 30 days.
o A decline in lung function of more than 15 % or oxyhemoglobin of < 90% after test nebulisation with hypertonic saline at screening visit17.
o Women with a current or intended pregnancy during the trial
o Diagnosis of quinine sulphate allergy
o Myasthenia Gravis
o Lambert-Eaton syndrome
o Optic neuritis
o Tinnitus
o Atrium fibrillation and other currently severe cardiac disease
o Epilepsy
o Glucose 6PD deficiency

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in St. George's Respiratory Questionnaire score.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change in Quality of Life questionnaire for bronchiectasis patients score, lung<br /><br>function, lung clearance index, sputum culture results, inflammatory markers in<br /><br>sputum and blood, exacerbation frequency. </p><br>