Anti-inflammatory effects of Glycopyrronium

Phase 1

• Conditions: Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-001762-14-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-29
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 28

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 = 8 mg/ml.
6.Drop in FEV1 > 20% during the early asthmatic response and drop in FEV1 > 15% during the late asthmatic response, i.e. between 3-8 hours after allergen challenge.
7.Patients able to produce sputum of sufficient quality for evaluation of cell differential counts 24 hours after the baseline allergen challenge at Visit 3.

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 28
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 ½ 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 <70% of predicted or < 1.5 liters.
4.Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1. If patients experience an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit, they may be re-screened 6 weeks after recovery from the exacerbation.
5.Patients who have had a respiratory tract infection or clinical significant asthma worsening as defined by Investigator within 4 weeks prior to Visit 1. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
6.Patients who have ever required intubation for a severe asthma attack/exacerbation.
7.Patients who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator’s medical judgment at risk participating in the study.
8.Patients treated with a LAMA for asthma within 3 months prior to Visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified