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AsthmaPhase 3NCT04259164

Anti-inflammatory Effects Glycopyrronium

A Phase 3 study testing QVM149 and QMF149 in people with Asthma and Allergic Asthma, run by University Medical Center Groningen at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma, Allergic Asthma
What is being tested?
QVM149 and QMF149
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteNetherlands
Study dates
10 Sep 2020to 29 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Smoking history ≥ 10 pack-years. Ex-smokers are eligible for inclusion if they quit smoking for at least 6 months prior to Visit 1.
  • 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.
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  • 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.
  • History of myocardial infarction within 12 months prior to Visit 1.
  • Concomitant use of agents known to prolong the QT interval unless it can be permanently discontinued for the duration of study.
  • History of long QT syndrome or QTc measured at Visit 1 (Fridericia method) is prolonged (> 450 msec for males and > 460 msec for females).
  • Clinically significant ECG abnormality at Visit 1.
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  • History of hypersensitivity to lactose, any of the study drugs or its excipients, or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
  • On maintenance immunotherapy (desensitization) for allergies for less than 3 months prior to Visit 1 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 1 but expected to change throughout the course of the study.
  • Unable to use the Breezhaler dry powder inhaler or a metered dose inhaler.
  • History of alcohol or other substance abuse that based on judgement of the investigator would interfere with study conduct.
  • Known history of non-compliance to medication.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and for 5-times the terminal half-life after stopping medication.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Groningen

    Groningen, 9713GZ

Other trials in Netherlands

About this study

Official title: Evaluation of the Anti-inflammatory Effects of Glycopyrronium Added to Indacaterol/Mometasone on the Allergen-induced Late Asthmatic Response

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.

Being tested
QVM149, QMF149
Keywords
Asthma, Anti-inflammatory, Allergen
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QVM149Drug

    Also called Mometasone/Indacaterol/Glycopyrronium

    Anti-inflammatory effect of Glycopyrronium added to Mometasone / Indacaterol

  • QMF149Drug

    Also called Mometasone/Indacaterol

    Mometasone / Indacaterol

Study groups in NCT04259164
Study groupRoleWhat they receive
QMF149Active comparatorMometasone furoaat / Indacaterol
Receives: Drug: QMF149
QVM149ExperimentalMometasone furoaat / Indacaterol / Glycopyrronium
Receives: Drug: QVM149

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. % of sputum eosinophils

    Percentage of sputum eosinophils

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2020
  2. Study start10 Sep 2020
  3. Primary completion29 Dec 2022
  4. Study completion29 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Double-blind, randomized, two-way cross-over study with two treatment periods.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04259164
Sponsor's protocol ID
ABR70842
Status last verified
Jan 2023
First submitted
4 Feb 2020
Last updated
12 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QVM149 and QMF149 in people with Asthma and Allergic Asthma, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% of sputum eosinophils (time frame: 24 hours after allergen challenge at the end of each treatment period vs. control allergen challenge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04259164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.

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