No registrations found.
ID
Source
Brief title
Health condition
Primary Ciliary Dyskinesia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary research question:
- Is there a significant difference in change in the St. George’s Respiratory Questionnaire total and sub-scores (SGRQ) within intervention periods?
Secondary outcome
Secondary 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?
Study objective
We 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.
Study design
6 visits: baseline, 6 weeks, 12 weeks, 16 weeks, 22 weeks, 28 weeks.
Intervention
A: 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
T. Paff
Department of pulmonology
VU University Medical Center, Amsterdam
Room PK 4X 023
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4445491
t.paff@vumc.nl
T. Paff
Department of pulmonology
VU University Medical Center, Amsterdam
Room PK 4X 023
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4445491
t.paff@vumc.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4498 |
| NTR-old | NTR4674 |
| Other | METC : 2013_198 |