CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
Blood collection +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02345135
NCT02345135N/ACompleted

Susceptibility to Infections in Patients With Ataxia Telangiectasia : A Prospective Follow-up Study

Johann Wolfgang Goethe University Hospital·interventional·Posted Jan 26, 2015·Updated Nov 30, 2017

In Brief

A clinical study evaluating Blood collection, Lung function measurement, and 1 other intervention for Ataxia Telangiectasia and 3 related conditions. Completed, enrolled 41 participants.

Detailed Summary

Death in Ataxia telangiectasia (A-T) is usually due to cancer or chronic lung failure around 20 years of age. Despite low lymphocyte counts (CD3, CD4, CD8 and CD19), IgA and IgG subclass deficiency opportunistic and acute severe respiratory infections are rare. The prevailing wisdom is that an immunoglobulin replacement therapy is not necessary in most of the patients. However no placebo controlled trials have been performed so far. The aim of this trial was to investigate the prevalence of mild and severe respiratory infections and / or chronic cough in classical A-T patients compared to healthy controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsCSL Behring

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 26, 2015
Enrollment StartSep 1, 2012
Primary CompletionJan 31, 2016
Study CompletionJul 31, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.4 years ago

Interventions

Blood collectionprocedure

In all patients with Ataxia telangiectasia blood was collected at each visit date to determine blood count, lymphocyte subpopulation count and immunoglobulin levels in serum (IgA, IgG, IgM, IgE), as well as alpha feto protein (AFP).

Lung function measurementprocedure

In all patients - Ataxia telangiectasia and healthy controls - a lung function measurement was done to determine vital capacity (VC), forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF) and Tiffenau index.

Symptom diarybehavioral

All patients - Ataxia telangiectasia and healthy controls - were requested to keep a symptom diary for the months September to March of the years 2012/2013 and 2013/2014 to determine days with symptoms as coughing during day and night, cold and fever, as well missing days at kindergarten/school/work, intake of medication (especially antibiotic treatment) and hospitalisations.