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In vivo assessment of the molecular mechanism of inhaled combination of beclomethasone and formoterol on cell differentiation factors and airway remodelling in COPD

In vivo assessment of the molecular mechanism of inhaled combination of beclomethasone and formoterol on cell differentiation factors and airway remodelling in COPD - Molecular action of beclomethason/formoterol in COPD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-000155-14-AT
Enrollment
Unknown
Registered
2013-11-22
Start date
2013-12-13
Completion date
Unknown
Last updated
2015-07-10

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

Conditions

COPD

Interventions

Trade Name: Foster Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: BECLOMETASONE DIPROPIONATE CAS Number: 5534-09-8 Concentration unit: µg microgram(s) Concentration type: equal

Sponsors

Med. Universität Wien, Universitätsklinik für Innere Medizin II
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Planned bronchoscopy stabel COPD GOLD 0-III (standard therapy) Age 18-80 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: exacerbation of COPD, COPD Gold IV systemic therapy with cortison

Design outcomes

Primary

MeasureTime frame
Main Objective: We hypothesise that inhalation of Foster synchronises the activation (nucleus accumulation) of the cell differentiation and proliferation regulating transcription factors (glucocorticoid receptors, C/EBP-a, PPAR-?); while Wnt/ß-catenin should either be suppress or located in the cytosol.;Secondary Objective: 1. cell differentiation factors, namely the glucocorticoid receptor, C/EBP-a and PPAR-? are located in the cytosol in tissue samples of untreated patients. 2. if the inhalation of Foster within 60 minutes activates the 3 differentiation factors (glucocorticoid receptor, C/EBP-a and PPAR-?), regardless of the underlying disease. 3. if the effect of the inhaled Foster on the 3 cell differentiation factors occurs independent of the cell type in the bronchial wall, or if there is a disease and cell type specific modification of the drug's action. 4. determine the activation of Wnt/ß-catenin activity in vivo before and after inhalation of Foster and aim to characterise the disease and cell type specific inhibition of Wnt/ß-catenin activity by Foster. 5. analyse the effect of Foster inhalation on histone acetylation and DNA methylation by in situ hybridisation, if sufficient tissue material is available.;Primary end point(s): refer to objectives;Timepoint(s) of evaluation of this end point: refer to objectives—

Secondary

MeasureTime frame
Secondary end point(s): refer to objectives;Timepoint(s) of evaluation of this end point: refer to objectives—

Countries

Austria

Contacts

Public ContactSubinvestigator

Dr. C. Lambers

christopher.lambers@meduniwien.ac.at00431404004776

Outcome results

None listed

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