Skip to main content
MedPathMedPath Home
Clinical Trials/ACTRN12619000564156
ACTRN12619000564156
Completed
Phase 3

Improving outcomes of children and adults with primary ciliary dyskinesia: a multi-centre, double-blind, double-dummy, 2x2 partial factorial, randomised controlled trial using azithromycin and erdosteine

Menzies School of Health Research0 sites117 target enrollmentApril 10, 2019
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionsprimary ciliary dyskinesiaRespiratory - Other respiratory disorders / diseasesHuman Genetics and Inherited Disorders - Other human genetics and inherited disorders

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
primary ciliary dyskinesia
Sponsor
Menzies School of Health Research
Enrollment
117
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 10, 2019
End Date
July 11, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Children or adults (aged 2\-.65 years)
  • •2\.Known PCD (defined by genetics or through electron microscopy) or probable PCD defined as (a) chronic wet/productive cough and a PICADAR score of at least 5 with nasal nitric oxide measurement (nNO) less than 77 nL/min \[or equivalent cut\-offs] on 2 occasions (when nNO levels can be measured i.e. aged over 5 years) or (b) clinician assessment based on medical history
  • •3\.At least two exacerbations in the last 18 months or one hospitalisation for respiratory exacerbation in the last 18 months; AND
  • •4\. Plan to remain at one of the study sites for at least 15 months

Exclusion Criteria

  • •1\.Cystic fibrosis
  • •2\.On regular azithromycin (within the last 8 weeks) but if a participant is too unstable off azithromycin (defined by the participant’s primary specialist), the participant may be enrolled and will just be allocated to the erdosteine/placebo component (1:1 allocation)
  • •3\.Past (last 6 months) or current infection with non\-tuberculous mycobacteria
  • •4\.Contraindication for macrolide or erdosteine use (e.g. liver dysfunction, hypersensitivity, renal failure, deficiency of the cystathionine\-synthetase enzyme, phenylketonuria, active peptic ulcer)
  • •5\.Pregnant, pregnancy planned (in next 12 months) or nursing mothers
  • •6\. Abnormal ECG (QTc over 460 msec) or history of cardiac arrhythmia
  • •7\. Previously randomised
  • •8\. Hospitalised in the last 4 weeks for respiratory instability

Outcomes

Primary Outcomes

Not specified

Similar Trials

Not yet recruiting
Not Applicable
Improving the health of children and adolescents with autoinflammatory diseases
DRKS00032447Deutsches Rheuma-Foschungszentrum Berlin250
Completed
Not Applicable
A feasibility study of the Parents under Pressure programme for improving outcomes for children and families affected by opioid-dependent fathersParental substance misuse and its effects on children and familiesMental and Behavioural Disorders
ISRCTN43209618niversity of Stirling25
Not yet recruiting
Not Applicable
A comparison between computer based Positive Search Training and Cognitive Behavioural Training in children with anxiety disorders an Australian Childhood Anxiety Treatment Study (A-CATS)Anxiety disordersMental Health - Anxiety
ACTRN12619000085178Griffith University380
Completed
Not Applicable
The role of physical activity in improving the well-being of children and youthWell-being and self-conceptNot Applicable
ISRCTN12496336niversity of Southern Denmark1,800
Not yet recruiting
Not Applicable
Intervention Studies to Improve Children's Social-Emotional SkillsChildren&#39s Social-Emotional Skills
JPRN-UMIN000050803Tokyo Medical and Dental University60