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Clinical Trials/NL-OMON34039
NL-OMON34039
Completed
Phase 3

Peripheral targeting of inhaled rhDNase for chronic obstructive asthma in childhood. - IDOL (Inhaled DNase in Asthmatic children with Obstructive Lung function)

Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites60 target enrollmentTBD
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Conditionsasthma10038716

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
asthma
Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment
60
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Age 6 \- 18 years;
  • •Asthma diagnosed according to GINA guidelines;
  • •Treatment with at least 400 microg/day inhaled Budesonide or equivalent (dose constant for at least 6 months) and bronchodilators as needed or daily;
  • •Clinically stable asthma while using a constant dose of inhaled corticosteroids (ICS);
  • •Persistent peripheral airways obstruction as assessed by pulmonary function testing, defined as:
  • •o Dissociation between FVC and FEF75 values: FEF75 at least 20% (absolute % predicted) lower than FVC. ;FVC within normal limits (for this study defined as FVC \> 80% pred).

Exclusion Criteria

  • •Asthma exacerbation with hospital admission in last 3 months;
  • •Intensive Care Unit (ICU) admission for asthma in last year;
  • •Current respiratory tract infection;
  • •Inability to follow instructions of the investigator;
  • •Inability to inhale rhDNase;
  • •Concomitant medical conditions that effect inhaled treatment (e.g. cleft palate, severe airway malacia);
  • •Neuromuscular disease;

Outcomes

Primary Outcomes

Not specified

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