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Clinical Trials/EUCTR2017-004424-29-NL
EUCTR2017-004424-29-NL
Active, not recruiting
Phase 1

Pharmacogenetics Use For Further treatment Improvement in childreN (PUFFIN) trial - PUFFI

Academic Medical Center0 sites25 target enrollmentDecember 21, 2017
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ConditionsChildren with persistent uncontrolled asthmaTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
DrugsRegistered long-acting beta2 agonists (LABA): salmeterol (generic, Serevent), formoterol (generic, Atimos, Oxis), olodacterol (Striverdi).Registered LABA/ICS combination products: salmeterol/fluticason (AirFluSal, generic, Seretide), beclometason or budesonide/formoterol (Foster, Bufoler, Duoresp, Flutiform, Symbicort), fluticasonfuroate/vilanterol (Relvar).Registered ICS: fluticasone, budesonide, beclometasone (generic, Qvar).

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Children with persistent uncontrolled asthma
Sponsor
Academic Medical Center
Enrollment
25
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 21, 2017
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Academic Medical Center

Eligibility Criteria

Inclusion Criteria

  • •\- Between 6\-18 years of age
  • •\- Doctor's diagnosis of asthma (ever) based on patient history, FEV1 reversibility \>\= 12% ever and/or bronchial
  • •hyperresponsiveness ever.
  • •\- Current asthma symptoms (based on ACT (\>\= 12 years) or c\-ACT (\< 12 years) score \<\= 19
  • •ICS use \>\= 3 months before inclusion (start dosage ICS treatment step 2 according to childhood asthma guideline (NVK))
  • •\- adequate inhalation technique
  • •\- self\-assessed good adherence to maintenance asthma treatment
  • •\- understanding of Dutch Language
  • •\- internet access at home, willing to fill in questionnaires
  • •Are the trial subjects under 18? yes

Exclusion Criteria

  • •\- active smoking
  • •\- congenital heart disease
  • •\- serious lung disease other than asthma
  • •\- LABA use in the past 6 months
  • •\- omalizumab use
  • •\- ICU admission in the previous year

Outcomes

Primary Outcomes

Not specified

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