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Tests treatment safety and results for Asthma
Official title Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma
ClinicalTrials.gov ID: NCT05222529
What this study is testing
What is Glycopyrronium bromide 25ug?
Glycopyrronium bromide 25ug is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for asthma.
Also referred to as NVA237.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to characterize the bronchodilator effect, systemic exposure and safety/tolerability of two different doses of inhaled glycopyrronium, when compared to placebo. Outcome of this study will be used to determine the dose of inhaled glycopyrronium for the development of fixed dose combination indacaterol/mometasone/glycopyrronium (QVM149) for children aged 6 to less than 12 years old with moderate to severe asthma.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11
You may be able to join if
- Confirmed diagnosis of asthma for at least 6 months
- Signed informed consent by parent(s)/legal guardian(s) and assent by the pediatric participant (depending on local requirements)
- Participant on stable dose of inhaled low-to-medium dose ICS with one additional controller for at least 4 weeks prior to run-in
- Pre-Bronchodilator FEV1 ≥60% to ≤90% of predicted normal at beginning of Run-in and randomization. If FEV1 eligibility criteria are not met at -45min...
- FEV1 reversibility, done using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in visit (Visit 20): increase \> and/or = 12%...
You likely can't join if
- Systemic corticosteroid use for any reason within 3 months of Run-in
- Participants on low to medium mono ICS alone
- Participants requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Screening (Visit...
- Participants who have had an asthma attack/exacerbation requiring a) systemic corticosteroids (SCS) or b) hospitalization or c) emergency room visit...
- Participants with a known narrow-angle glaucoma, bladder dysfunction, bladder outlet obstruction or any other conditions where anticholinergic...
- Participants with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in and confirmed at Baseline (prior to...
See the full eligibility criteria
- Confirmed diagnosis of asthma for at least 6 months
- Signed informed consent by parent(s)/legal guardian(s) and assent by the pediatric participant (depending on local requirements)
- Participant on stable dose of inhaled low-to-medium dose ICS with one additional controller for at least 4 weeks prior to run-in
- Pre-Bronchodilator FEV1 ≥60% to ≤90% of predicted normal at beginning of Run-in and randomization. If FEV1 eligibility criteria are not met at -45min pre-dose of the End of Run-in (Visit 30), the visit can be...
- FEV1 reversibility, done using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in visit (Visit 20): increase \> and/or = 12% (performed according to American Thoracic Society (ATS)/European...
- Demonstrated acceptable inhaler use technique for Diskus/Accuhaler (prior to run-in) and Breezhaler (prior to randomization) and able to complete spirometry procedures prior to randomization.
- A parent/legal guardian must be designated to complete all e-Diary entries and attend all clinic visits with the participant.
- Parents/legal guardian must be willing and able to assist the child with the procedures outlined in the protocol, e.g. compliance with study medication, completion of electronic participant diary
- Female participants of child-bearing potential, who might become sexually active, must be informed of the need to prevent pregnancy during the study using effective contraceptive methods. The decision on the...
- Systemic corticosteroid use for any reason within 3 months of Run-in
- Participants on low to medium mono ICS alone
- Participants requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Screening (Visit 1) and/or in the four weeks prior to the Run-in visit
- Participants who have had an asthma attack/exacerbation requiring a) systemic corticosteroids (SCS) or b) hospitalization or c) emergency room visit, within 3 months prior to Screening (Visit 1), or more than 3 separate...
- Participants with a known narrow-angle glaucoma, bladder dysfunction, bladder outlet obstruction or any other conditions where anticholinergic treatment is contraindicated prior to Screening (Visit 1)
- Participants with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in and confirmed at Baseline (prior to randomization) (Fridericia method) is prolonged (\> 450 msec for boys...
- Suspected or documented active infections (bacterial, viral, fungal, mycobacterial or other, including active SARS-CoV-2, tuberculosis or atypical mycobacterial disease) of the upper or lower respiratory tract, sinus or...
- History of Type I diabetes or uncontrolled Type II diabetes
- Participants who are sexually active at screening
- Hemoglobin levels outside normal ranges at Run-in (Visit 20)
- Female patients of childbearing potential (e.g., are menstruating) who do not agree to abstinence or, if they become sexually active during study participation, do not agree to the use of contraception as defined in the...
The study team makes the final eligibility decision.
Where it's taking place
- Rousse, Bulgaria
- Sevlievo, Bulgaria
- Sofia, Bulgaria
- Ibague, Tolima Department, Colombia
- Guatemala City, GTM, Guatemala
- Guatemala City, Guatemala
- Debrecen, Hajdu Bihar Megye, Hungary
- Budapest, Hungary
- Eger, Hungary
- Kaposvár, Hungary
- Nagykanizsa, Hungary
- Szigetvár, Hungary
- Tarnów, Poland, Poland
- Lodz, Łódź Voivodeship, Poland
- George, Western Cape, South Africa
- Cape Town, South Africa
- Esplugues, Barcelona, Spain
- Sabadell, Barcelona, Spain
- Mérida, Extremadura, Spain
- Barcelona, Spain
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rousse, Bulgaria; Sevlievo, Bulgaria; Sofia, Bulgaria; Ibague, Tolima Department, Colombia; Guatemala City, GTM, Guatemala; Guatemala City, Guatemala and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.