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Hypertonic saline in Primary Ciliary Dyskinesia: a pilot study


- candidate number18375
- NTR NumberNTR4674
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2014
- Secondary IDs2013_198 METC
- Public TitleHypertonic saline in Primary Ciliary Dyskinesia: a pilot study
- Scientific TitleHypertonic saline in Primary Ciliary Dyskinesia: a pilot study
- ACRONYMHS study
- hypothesisWe hypothesize that bi-daily 5ml NaCl 7% nebulizations improve respiratory symptoms and quality of life in PCD patients compared to 5ml NaCl 0,9% nebulizations.
- Healt Condition(s) or Problem(s) studiedPrimary ciliary dyskinesia
- Inclusion criteria* Diagnosis of primary ciliary dyskinesia
* ≥ 18 years of age
* Capable of performing lung function tests.
* 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* Smoking
* FEV1 < 40 %.
* Use of Pulmozyme or other mucolytics or non-routine antibiotics in the previous 30 days.
* A decline in lung function of more than 15 % or oxyhemoglobin of < 90% after test nebulization with hypertonic saline at screening visit
* Women with a current or intended pregnancy during the trial
* Diagnosis of quinine sulphate allergy
* Myasthenia Gravis
* Lambert-Eaton syndrome
* Optic neuritis
* Tinnitus
* Atrium fibrillation and other severe cardiac heart disease
* Epilepsy
* Glucose 6PD deficiency
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-sep-2013
- planned closingdate1-jun-2015
- Target number of participants20
- InterventionsA: NaCl 7% nebulization with 0,25mg/ml quinine sulphate as taste masking agent
B: NaCl 0,9% nebulization with 0,25mg/ml quinine sulphate as taste masking agent
- Primary outcomePrimary research question:
- Is there a significant difference in change in the St. Georgeís Respiratory Questionnaire total and sub-scores (SGRQ) within intervention periods?
- Secondary outcomeSecondary research questions:
- Are there significant differences in change in the Quality of Life score for bronchiectasis patients score (QoL-B) , lung function, lung clearance index, respiratory culture results, inflammatory parameters in sputum and blood and exacerbation frequency?
- What are the effect sizes of these differences in PCD patients?
- Timepoints6 visits: baseline, 6 weeks, 12 weeks, 16 weeks, 22 weeks, 28 weeks.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. T. Paff
- CONTACT for SCIENTIFIC QUERIESMD. PhD. E.G. Haarman
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
PCD patiŽntenorganisatie
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD15-jul-2014 - 10-aug-2014


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