NL-OMON40843CompletedPhase 4
Hypertonic saline in primary ciliary dyskinesia: a pilot study - Hypertonic saline in primary ciliary dyskinesia
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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 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 Atrium fibrillation and other currently severe cardiac disease
- •o Glucose 6PD deficiency
Investigators
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