Evaluation of the anti-inflammatory effects of glycopyrronium added to indacaterol/mometasone on the allergen-induced late asthmatic response

Evaluation of the anti-inflammatory effects of glycopyrronium added to indacaterol/mometasone on the allergen-induced late asthmatic response - Anti-inflammatory effects of Glycopyrronium

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49783

Enrollment

Registered

2020-07-02

Start date

2020-09-10

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

asthma

Interventions

Indacaterol/glycopyrronium/Mometasone (QVM) 150/50/80 µg once daily versus Indacaterol/Mometasone (QMF) 150/160 µg once daily

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Male and female adult patients aged between 18 and 65 years old. 3. Patients with a diagnosis of asthma for at least 6 months prior to Visit 1 with current asthma severity of step 1-3 (GINA 2018). 4. Patients with presence of allergy against house dust mite, cat or grass pollen. 5. PC20 methacholine

Exclusion criteria

Exclusion criteria: 1. Patients who have a smoking history >= 10 pack-years (Note: 1 pack is equivalent to 20 cigarettes. 10 pack years = 1 pack/day x 10 years or * pack/day x 20 years). Ex-smokers are eligible for inclusion if they quit smoking for at least 6 months prior to Visit 1. 2. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). 3. Patients with severe airway obstruction at baseline, FEV1

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the reduction in the percentage of sputum eosinophils 24 hours after allergen challenge at the end of each treatment period vs. control allergen challenge.	—

Secondary

Measure	Time frame
Change from baseline after allergen challenge of: • Cell differential counts in blood and sputum 24 hours after allergen challenge. • Bronchial and alveolar nitric oxide. • Multiple Breath Nitrogen Washout (Lung Clearance Index (LCI), Scond, Sacin). • Lung function (FEV1, FEV1/FVC, FEF25, FEF50, FEF75, FEF25-75). • Body plethysmography (RV (% predicted), RV/TLC % predicted). • Impulse Oscillometry. Resistance (R5, R20, R5-20) and Reactance at 5 Hertz (IOS). • Genome-wide mRNA and miRNA expression in sputum and in epithelial cells derived from nasal epithelial brushes.	—

Measure

Time frame

Change from baseline after allergen challenge of: • Cell differential counts in blood and sputum 24 hours after allergen challenge. • Bronchial and alveolar nitric oxide. • Multiple Breath Nitrogen Washout (Lung Clearance Index (LCI), Scond, Sacin). • Lung function (FEV1, FEV1/FVC, FEF25, FEF50, FEF75, FEF25-75). • Body plethysmography (RV (% predicted), RV/TLC % predicted). • Impulse Oscillometry. Resistance (R5, R20, R5-20) and Reactance at 5 Hertz (IOS). • Genome-wide mRNA and miRNA expression in sputum and in epithelial cells derived from nasal epithelial brushes.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)