Anti-inflammatory Effects Glycopyrronium

NCT04259164 | Completed Phase 3 DMC

• 1 other identifier: ABR70842
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Double-blind, randomized, two-way cross-over study with two treatment periods. 28 subjects with asthma will be randomized in 1:1 ratio to treatment A) Indacaterol/Mometasone 150/160 μg once daily and treatment B) Indacaterol/Glycopyrronium/Mometasone 150/50/80 μg once daily for period 1. For period 2, subjects will be crossed over to the other treatment arm. Subjects will be screened during the first visit. After inclusion subjects will be seen for 3 visits during the Run-in period, 3 visits during treatment period 1 and 3 visits during treatment period 2. During these visits patients will be clinically characterized and exposed to allergen challenge tests.

Conditions

Asthma; Allergic Asthma

Keywords

Asthma; Anti-inflammatory; Allergen

Outcome Measures

Primary Outcomes (1)

• % of sputum eosinophils

  Percentage of sputum eosinophils

  24 hours after allergen challenge at the end of each treatment period vs. control allergen challenge

Study Arms (2)

QMF149

ACTIVE COMPARATOR

Mometasone furoaat / Indacaterol

Drug: QMF149

QVM149

EXPERIMENTAL

Mometasone furoaat / Indacaterol / Glycopyrronium

Drug: QVM149

Interventions

QVM149 DRUG

Anti-inflammatory effect of Glycopyrronium added to Mometasone / Indacaterol

Also known as: Mometasone/Indacaterol/Glycopyrronium

QVM149

QMF149 DRUG

Mometasone / Indacaterol

Also known as: Mometasone/Indacaterol

QMF149

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study.
• Male or female adult patients aged between 18 and 65 years old.
• 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).
• Patients with presence of allergy against house dust mite, cat or grass pollen.
• PC20 histamine or equivalent ≤ 8 mg/ml.
• 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.
• Patients able to produce sputum of sufficient quality for evaluation of cell differential counts 24 hours after the baseline allergen challenge at Visit 3.

You may not qualify if:

• Diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
• FEV1 \< 70% of predicted at baseline or \< 1.5 liters.
• An asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1.
• Respiratory tract infection or clinically significant asthma worsening as defined by Investigator within 4 weeks prior to Visit 1.
• Ever required intubation for a severe asthma attack/exacerbation.
• Presence of clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures).
• Treated with LAMA for asthma within 3 months prior to Visit 1.
• Known with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention.
• Known with any chronic conditions affecting the upper respiratory tract (e.g. chronic sinusitis or polyposis nasi) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study. Allergic rhinitis is allowed.
• History of chronic lung diseases other than asthma, including (but not limited to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
• Uncontrolled Type I or Type II diabetes.
• Clinically significant laboratory abnormality at Visit 1.
• Use of other investigational drugs within 30 days or 5 half-lives of enrollment, until the expected pharmacodynamics effect has returned to baseline, whichever is longer.
• Clinically significant condition such as (but not limited to) unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left ventricular failure, arrhythmia, uncontrolled hypertension, cerebrovascular disease, psychiatric disease, neurodegenerative diseases, or other neurological disease, uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia, hyper adrenergic state, or ophthalmologic disorder or patients with a medical condition that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
• Diagnosis of paroxysmal (e.g., intermittent) atrial fibrillation.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Novartis: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

MeSH Terms

Conditions

Asthma

Interventions

Mometasone Furoate; QMF149; indacaterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Maarten Van den Berge, Dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double-blind, randomized, two-way cross-over study with two treatment periods.

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: September 10, 2020
• Primary Completion: December 29, 2022
• Study Completion: December 29, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

NL (1)