TARGET “Targeting the small airways in asthma”

TARGET “Targeting the small airways in asthma” Does fine particle ICS improve peripheral airway inflammation and function in patients with insufficient response to large particle ICS? - TARGET

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001143-31-DK

Enrollment

Registered

2013-06-28

Start date

2013-07-08

Completion date

Unknown

Last updated

2016-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 17.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Ciclesonide (Alvesco) Product Name: Ciclesonide Pharmaceutical Form: Inhalation vapour INN or Proposed INN: CICLESONIDE CAS Number: 141845-82-1 Concentration unit: µg microgram(s) Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Asthma diagnosed by at least one objective test within last 12 months: ? positive bronchial provocation test (mannitol or methacholine), ? reversibility to beta-2 agonist (> 12 %, and > 250 mL) or ? PEF variation (>20%) With 1. Treated with daily ICS +/- LABA for at least 3 months 2. Partly controlled or uncontrolled asthma according to GINA guidelines definitions, and 3. Positive mannitol bronchial provocation test (PD15 25 ppb) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Other lung diseases 2. Active smoking past 12 months 3. Ex-smokers ( 10 pack years) 4. Pregnancy or lactation 5. Respiratory infection (past 6 weeks)

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to clarify, whether patients with poor asthma control despite of ICS treatment, who also have signs of airways inflammation, demonstrate a greater reduction in their airway inflammation, when small particle ICS added to their treatment, rather than large particle ICS.;Secondary Objective: To investigate whether patients with poor asthma control despite of ICS treatment, who also have signs of airways inflammation, demonstrate a greater reduction in their airway dysfunction, when small particle ICS added to their treatment, rather than large particle ICS.;Primary end point(s): Change in FeNO (ppb) ;Timepoint(s) of evaluation of this end point: After 12 weeks treatment	—

Measure

Time frame

Main Objective: The aim of this study is to clarify, whether patients with poor asthma control despite of ICS treatment, who also have signs of airways inflammation, demonstrate a greater reduction in their airway inflammation, when small particle ICS added to their treatment, rather than large particle ICS.;Secondary Objective: To investigate whether patients with poor asthma control despite of ICS treatment, who also have signs of airways inflammation, demonstrate a greater reduction in their airway dysfunction, when small particle ICS added to their treatment, rather than large particle ICS.;Primary end point(s): Change in FeNO (ppb) ;Timepoint(s) of evaluation of this end point: After 12 weeks treatment

—

Secondary

Measure	Time frame
Secondary end point(s): ? Sputum % eosinphils, ECP and Eoxtaxin ? Serum eosinophils, ECP, eotaxin ? CANO (ppb) ? Small airways dysfunction (Forced oscillation technique. R5-25; index of the frequency dependence of resistance, a measure of small airways dysfunction) ? FEF25-75 ? ACQ score ;Timepoint(s) of evaluation of this end point: After 12 weeks treatment	—

Countries

Denmark

Contacts

Public ContactRespiratory Research Unit

Bispebjerg Hospital

celeste.porsbjerg@regionh.dk+4535313569

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026