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

Phase 3

Completed

• Conditions: asthma; bronchitis; 10006436

• Registration Number: NL-OMON49783
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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 of 20% or more during the early asthmatic response and drop in
FEV1 of 15% or more 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.

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 < 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
• Study Design: Not specified