A Phase 2 interventional study of Glycopyrronium bromide 25ug and Placebo in Asthma, sponsored by Novartis Pharmaceuticals. Recruiting at 23 sites in 8 countries. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
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.
The study design is a double-blind, placebo controlled, randomized sequence, three-treatment, three-period, six-sequence, cross-over multiple-dose study to evaluate efficacy, pharmacokinetics, pharmacodynamics, and safety and tolerability of glycopyrronium bromide (bromide) in children from 6 to less than 12 years of age with asthma with forced expiratory volume in one second (FEV1) ≥60% and ≤ 90% of the predicted normal value for the participant.
This study will consist of 4 phases: Screening, Run-in, Treatment and Follow-up.
After the screening phase, participants will enter the Run-in Phase to further assess eligibility and those participants that meet all eligibility criteria will be randomized. Study treatment will be administered in addition to background asthma LABA+ICS controller therapy (salmeterol xinafoate 50µg/fluticasone propionate 100µg) from entering the run-in period, through to the end of the treatment phase, including the 2 wash-out periods. Participants will be randomized to one of 6 different sequences with an equal (1:1:1:1:1:1) randomization ratio. The Treatment Phase will last 10 weeks, and every sequence is divided in three treatment periods: Glycopyrronium bromide 12.5 µg, Glycopyrronium bromide 25µg or matching placebo dry powder in capsules for inhalation, via Breezhaler. Each treatment period lasts 2 weeks and 2 consecutive treatment periods are separated by a 2-week wash-out period. Participants who discontinue their study treatment prematurely will be required to return to the clinic for an Early Termination Visit. 30 days after last treatment date, a final telephone contact must be conducted for safety follow-up.
The total duration of the trial for a participant (from screening to follow up) is approximately 20 weeks including safety follow-up.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 42 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Additional protocol-defined inclusion / exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Glycopyrronium 25μg for two weeks
Drug: Glycopyrronium bromide 25ug · Drug: Placebo · Drug: Glycopyrronium bromide 12.5ug
Glycopyrronium 12.5μg for two weeks
Drug: Glycopyrronium bromide 25ug · Drug: Placebo · Drug: Glycopyrronium bromide 12.5ug
Placebo for two weeks
Drug: Glycopyrronium bromide 25ug · Drug: Placebo · Drug: Glycopyrronium bromide 12.5ug
25μg Glycopyrronium bromide capsules for oral inhalation via Breezhaler
Also known as: NVA237
Placebo to Glycopyrronium bromide capsules for oral inhalation via Breezhaler
12.5ug Glycopyrronium bromide capsules for oral inhalation via Breezhaler
Also known as: NVA237
Change from Baseline in trough FEV1
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.
Time frame: At the start and end of each 2 week treatment period (Days 1, 14, 29, 42, 57 and 70)
Steady state pharmacokinetic (PK) parameters C0
Steady state pharmacokinetic (PK) parameters C0 will be provided for plasma glycopyrronium concentrations at pre-dose and post-dose time-points.
Time frame: At the start and end of each 2 week treatment period (Days 1, 14, 15, 29, 42, 43, 57, 70 and 71)
Systemic exposure following sparse PK sampling
Systemic exposure following sparse PK sampling will be provided at pre-dose and post-dose time-points for each glycopyrronium dose level
Time frame: At the start and end of each 2 week treatment period (Days 1, 14, 15, 29, 42, 43, 57, 70 and 71)
Change from Baseline in PEF rate
Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration.
Time frame: At the start and end of each 2 week treatment period (Days 1, 14, 15, 29, 42, 43, 57, 70 and 71)
Change from Baseline in FEV1
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.
Time frame: At the start and end of each 2 week treatment period (Days 1, 14, 15, 29, 42, 43, 57, 70 and 71)
Change from baseline in rescue medication use
Daily use of rescue medication will be recorded each morning and evening throughout the 2 week treatment by the participant using their electronic diary.
Time frame: At the start and end of each 2 week treatment period (Days 1, 14, 15, 29, 42, 43, 57, 70 and 71)
Adverse events of special interest (AESI) typical of anti-muscarinic side effects
AESIs that are typical of anti-muscarinic agents will be reported.
Time frame: From the start of run-in to 30 days after end of treatment, assessed up to maximum duration of 16 weeks
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Glycopyrrolate