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Effects Of extra-fine particle HFA-becLomethasone (HFA-QVAR) Versus course particle treatment In smokers and ex-smokers with Asthma

Effects Of extra-fine particle HFA-becLomethasone (HFA-QVAR) Versus course particle treatment In smokers and ex-smokers with Asthma - Effects of QVAR in smokers and ex-smokers with asthma

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38937
Enrollment
40
Registered
2013-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Asthma Astmatic bronchitis

Interventions

There are three treatment periods of two weeks: A: 2-week treatment with HFA-QVAR (TEVA) 200 *g b.i.d. B: 2-week treatment with HFA-Clenil (Chiesi) 400 *g b.i.d. C: 2-week treatment with HFA-Flutica

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *Males and females with a doctor*s diagnosis of asthma ;*Age between 18 and 65 years;*Current- and ex-smokers with * 5 packyears.;*Drop in FEV1 > 20% after provocation with small particle adenosine

Exclusion criteria

Exclusion criteria: *An asthma exacerbation during the last 6 weeks or upper respiration tract infection during the last 4 weeks prior to inclusion in the study. ;*Severe airway obstruction at visit 1, 2, of 3, i.e. FEV1

Design outcomes

Primary

MeasureTime frame
The primary end-parameter is the PD20 small particle adenosine. The co-primary objective (only in case of non-inferiority of QVAR on the primary objective) will be: Reduction in peripheral airways resistance (R5-R20) measured with IOS at the provocative dose of small particle adenosine causing the FEV1 to drop with 20% (PD20).—

Secondary

MeasureTime frame
* Twice daily symptoms (including night-time symptoms) and peakflow (PEF). * Resistance (R5, R20, R5-R20) and Reactance at 5 Herz (X5) with IOS. * Lung function (FEF25, FEF50, FEF75, FEF25-75, PEF, FEV1, FEV1/FVC, FVC/SVC * Body plethysmography (RV (%predicted), TLC, RV/TLC (%), FRC, FRC/TLC (%), FRC/TLC (%predicted), IC, RV/TLC %predicted). * Peripheral blood (cell differential counts). * Delta FVC during PD20 small particle adenosine. * Questionnaires (Asthma Control Questionnaire (ACQ), Bronchial Hyperresponsiveness Questionnaire (BHQ), and Clinical COPD Questionnaire (CCQ). * Multiple Breath Washout Analysis: Lung Clearance Index, Sacin and Scond before and after provocation test with AMP and small particle adenosine. * Genome-wide mRNA and miRNA expression, and DNA methylation in epithelial cells derived from nasal epithelial brushes. * inflammatory cytokines and chemokines in nasal lining fluid—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)