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AsthmaPhase 3NCT05562466

A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma

A Phase 3 study testing QMF149 and Budesonide in people with Asthma, run by Novartis Pharmaceuticals at 65 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma. Read more about this study

Who is it for?
Ages 6 to 11 years
Conditions the study is for
Asthma
What is being tested?
QMF149 and Budesonide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
65 sitesin 17 countries
Study dates
11 May 2023to 30 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 6 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male or female children ≥ 6 years and <12 years in age at randomization.
  • Parents/legal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing the diary) ((≥ 70% during the last 14 days of the Run-in period)).
  • Confirmed/documented diagnosis of asthma, as defined by national or international asthma guidelines for at least 12 months prior to study enrollment.
  • Written and signed informed consent by parent(s)/legal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.
  • Patient receiving daily treatment of stable low dose ICS alone (i.e. up to 100ug daily dose of fluticasone propionate DPI or equivalent) without additional controller OR low dose ICS (up to 100ug daily dose of fluticasone propionate DPI or equivalent) with one additional controller prior to starting run-in and eligible after run-in on mono ICS alone (fluticasone 100ug/day) for at least 3 weeks (run-in period) prior to randomization.
  • All patients must be symptomatic at randomization (Visit 30), as defined by ACQ-IA≥1.5. Patients previously on low dose ICS may be included for run-in only if ACQ-IA score ≥1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.
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  • Patients previously on low dose ICS with one controller may do the wash out of the controller before the start of run-in and be included for run-in only if ACQ-IA score ≥ 1 and <1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.
  • Pre-Bronchodilator FEV1 ≥50% of predicted normal at start of Run-in (Visit 20) and end of Run-in (Visit 30).
  • Withholding period of bronchodilators prior to spirometry at all time:
  • SABA for ≥ 6 hours. For loose combinations of ICS/LABA a wash-out of ≥ 48 hours before Visit 20 is required (14 days for once daily combinations, i.e. indacaterol), short acting anticholinergic (SAMA) for ≥ 8 hours and xanthines ≥7 days.
  • In case of combination ICS/LABA at screening, ICS alone should be continued. Wash-out period of each drug should be adhered to as above and should not be longer. If wash-out period is considered to be longer, please contact the Novartis Medical Monitor.
  • A one-time repeat of percent predicted FEV1 (pre-bronchodilator FEV1) within 5 days of the Visit is allowed at Visit 20 as well as Visit 30. That would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment. At Visit 20, the Run-in medication should be dispensed only once the repeat spirometry was qualified, and if all inclusion criteria at Visit 20 are successfully met.
  • If patient fails to meet the pre FEV1 criteria for technical reasons, a rescreen is allowed once and in this circumstance, patients are not required to go back on prior medication (low dose ICS with or without controller) for the full 4 weeks duration and the rescreen can be scheduled at site's convenience. In this case all assessments must be done according to protocol's requirements.
  • FEV1 bronchodilator responsiveness testing 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 ATS/ERS 2019 guidelines). All patients must perform a bronchodilator responsiveness test at start of Run-in. If responsiveness is not demonstrated at Run-in, it may be repeated once on the same day. If responsiveness is still not demonstrated after repeat, documentation of historical reversibility is accepted. If not available patients must be screen failed. Spacers may be used for bronchodilator responsiveness testing.
  • Demonstrate acceptable inhaler use technique with Breezhaler® at randomization, as well as acceptable use of other study devices and be able to complete spirometry procedures.
  • A parent/legal guardian is to complete all e-Diary entries and attend all clinic visits with the patient. It is recommended, if possible, to have the same parent/legal guardian to complete the e-diary entries and attend clinic visits with the patient.
  • Have a documented negative COVID-19 test (validated PCR or antigenic test)) within 3 days prior to randomization visit.
  • For optional Pharmacokinetics (PK) analysis: Participants willing to participate in the optional PK analysis will need to weigh at least 25 kg at screening.
  • Exclusion Criteria Participants meeting any of the following criteria are not eligible for inclusion in this study.
  • Prior intubation for asthma.
  • Patients who have had a severe asthma exacerbation requiring in the previous month either systemic steroids or hospitalization due to asthma (>24h) or emergency room visit (≤24 hours).
  • Subjects receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day 1) and follow the adjustment through the treatment period.
  • Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.
  • History or presence of impaired renal function as indicated by clinically significant abnormal creatinine or blood urea nitrogen (BUN) and/or urea values, or abnormal urinary constituents (e.g. albuminuria) according to investigator's judgement.
  • Evidence of urinary obstruction, or difficulty in voiding
  • Evidence of congenital renal abnormalities with an established effect on renal function
  • Calculated eGFR <60 mL/min/1.73m2 using the Bedside Schwartz formula.
  • Patients who have had a respiratory tract infection as determined by the investigator within 4 weeks prior to Visit 1, or between Visit 1 and Visit 30.
  • Patients may be re-screened once, 4 weeks after recovery from their respiratory tract infection.
  • Any chronic condition of the respiratory tract which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.
  • Patient with evidence upon visual inspection (laboratory culture not required) of clinically significant (upon the opinion of the investigator) oropharyngeal candidiasis at Visit 30 or earlier, with or without treatment, Patients may be rescreened once their candidiasis has been treated and has resolved.
  • History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease), chronic obstructive pulmonary disease (COPD) and asthma/COPD overlap syndrome (ACOS).
  • Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in or Baseline (Fridericia method) is prolonged (≥ 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened).
  • Subjects who have a clinically significant ECG abnormality reported before Visit 30 (End of Run-in).
  • Subjects who have a clinically significant abnormal laboratory values as per investigator judgement or abnormal liver chemistry results (i.e. ALT, AST, total bilirubin, alkaline phosphatase, GGT and albumin above the upper limit of normal) reported before Visit 30 (End of Run-in).
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
  • Subjects who, in the opinion of the investigator, are not able to be compliant with study treatment or who have any medical or mental disorder, situation, or diagnosis which could interfere with the proper completion of the protocol requirements or risk the subject's safety while participating in the study.
  • Subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
  • Patients who have been treated with long-acting theophylline preparations within four weeks prior to Screening and/or during the screening period or who have been treated with short-acting theophylline preparations within two weeks prior to Screening.
  • Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period.
  • Use of Long-Acting Muscarinic Antagonist (LAMA) as maintenance treatment within 3 months prior to Screening.
  • Evidence of unstable disease within 4 weeks prior to Screening (Visit 1) that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.
  • History of hypersensitivity to any ingredients of the study drugs including fluticasone propionate, indacaterol acetate, mometasone furoate, budesonide and salmeterol/albuterol or drug of similar chemical classes. This includes any known hypersensitivity or intolerance to the excipients, including lactose.
  • Patients with Type I diabetes or uncontrolled Type II diabetes either by HBA1c>8 or as per judgement of investigator prior to End of Run-In (Visit 30)
  • Patients receiving any asthma-related or non asthma-related prohibited medications as specified in the protocol.
  • Immunotherapy or desensitization for allergies started within 3 months prior to Visit 20, or where the maintenance dose is expected to change during the study.
  • Female patients of childbearing potential defined as all females physiologically capable of becoming pregnant (including female pediatric patients who are menarchal or who become menarchal during the study)) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria.
  • Effective contraception methods include:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
  • Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For UK: with spermicidal foam/gel/film/cream/ vaginal suppository
  • Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) If using oral contraception females should have been stable on the same pill for a minimum of 3 months before taking investigational drug. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.

Who cannot join

None listed.

Trial locations and contacts

65 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

+41613241111

novartis.email@novartis.com

Novartis Pharmaceuticals contact

65 sites in 17 countries

South Africa8 sites, 6 recruiting

  • Novartis Investigative Site

    Bloemfontein, Free State, 9301

    Recruiting

  • Novartis Investigative Site

    Cape Town, Western Cape, 7130

    Withdrawn

  • Novartis Investigative Site

    Cape Town, Western Province, 7700

    Recruiting

  • Novartis Investigative Site

    Cape Town, 7531

    Recruiting

  • Novartis Investigative Site

    Centurion, 0157

    Recruiting

  • Novartis Investigative Site

    George, Western Cape, 6529

    Withdrawn

  • Novartis Investigative Site

    Pretoria, Gauteng, 0181

    Recruiting

  • Novartis Investigative Site

    Raslouw Centurion, Gauteng, 0157

    Recruiting

Other trials in South Africa

Argentina6 sites, 6 recruiting

  • Novartis Investigative Site

    CABA, Buenos Aires, C1122AAK

    Recruiting

  • Novartis Investigative Site

    CABA, Buenos Aires, C1414AIF

    Recruiting

  • Novartis Investigative Site

    CABA, Buenos Aires, C1425BEN

    Recruiting

  • Novartis Investigative Site

    Mendoza, Mendoza Province, M5500AFD

    Recruiting

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DEJ

    Recruiting

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000JKR

    Recruiting

Other trials in Argentina

Italy6 sites, 3 recruiting

  • Novartis Investigative Site

    Brescia, BS, 25123

    Withdrawn

  • Novartis Investigative Site

    Catania, CT, 95123

    Recruiting

  • Novartis Investigative Site

    Florence, FI, 50139

    Withdrawn

  • Novartis Investigative Site

    Naples, 80138

    Recruiting

  • Novartis Investigative Site

    Pavia, PV, 27100

    Withdrawn

  • Novartis Investigative Site

    Roma, RM, 00161

    Recruiting

Other trials in Italy

Spain6 sites, 6 recruiting

  • Novartis Investigative Site

    Barcelona, 08035

    Recruiting

  • Novartis Investigative Site

    Córdoba, 14004

    Recruiting

  • Novartis Investigative Site

    Esplugues, Barcelona, 08950

    Recruiting

  • Novartis Investigative Site

    Madrid, 28034

    Recruiting

  • Novartis Investigative Site

    Málaga, 29011

    Recruiting

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

    Recruiting

Other trials in Spain

Greece5 sites, 3 recruiting

  • Novartis Investigative Site

    Athens, 115 27

    Recruiting

  • Novartis Investigative Site

    Chaïdári, 124 62

    Withdrawn

  • Novartis Investigative Site

    Heraklion Crete., 715 00

    Recruiting

  • Novartis Investigative Site

    Pátrai, 265 04

    Active, not recruiting

  • Novartis Investigative Site

    Thessaloniki, 546 42

    Recruiting

Other trials in Greece

Mexico5 sites, 5 recruiting

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44100

    Recruiting

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44130

    Recruiting

  • Novartis Investigative Site

    Querétaro, 76000

    Recruiting

  • Novartis Investigative Site

    San Juan del Río, Querétaro, 76800

    Recruiting

  • Novartis Investigative Site

    Villahermosa, Tabasco, 86035

    Recruiting

Other trials in Mexico

Hungary4 sites, 4 recruiting

  • Novartis Investigative Site

    Budapest, 1033

    Recruiting

  • Novartis Investigative Site

    Gödöllő, 2100

    Recruiting

  • Novartis Investigative Site

    Szeged, 6720

    Recruiting

  • Novartis Investigative Site

    Szigetvár, 7900

    Recruiting

Other trials in Hungary

Portugal4 sites, 3 recruiting

  • Novartis Investigative Site

    Lisbon, 1649-035

    Recruiting

  • Novartis Investigative Site

    Lisbon, 1998-018

    Recruiting

  • Novartis Investigative Site

    Porto, 4099-001

    Withdrawn

  • Novartis Investigative Site

    Porto, 4100-180

    Recruiting

Other trials in Portugal

Austria3 sites

  • Novartis Investigative Site

    Graz, 8036

    Withdrawn

  • Novartis Investigative Site

    Salzburg, 5020

    Withdrawn

  • Novartis Investigative Site

    Sankt Pölten, 3100

    Withdrawn

Other trials in Austria

Brazil3 sites, 3 recruiting

  • Novartis Investigative Site

    Brasília, Federal District, 70684-831

    Recruiting

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90160-093

    Recruiting

  • Novartis Investigative Site

    Sorocaba, São Paulo, 18040-425

    Recruiting

Other trials in Brazil

Colombia3 sites, 3 recruiting

  • Novartis Investigative Site

    Bucaramanga, Santander Department, 680001

    Recruiting

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760001

    Recruiting

  • Novartis Investigative Site

    Ibague, Tolima Department, 730006

    Recruiting

Other trials in Colombia

Vietnam3 sites, 3 recruiting

  • Novartis Investigative Site

    Haiphong, 180000

    Recruiting

  • Novartis Investigative Site

    Hanoi, 100000

    Recruiting

  • Novartis Investigative Site

    Ho Chi Minh City, 700000

    Recruiting

Other trials in Vietnam

Bulgaria2 sites, 2 recruiting

  • Novartis Investigative Site

    Rousse, 7002

    Recruiting

  • Novartis Investigative Site

    Sevlievo, 5400

    Recruiting

Other trials in Bulgaria

Czechia2 sites

  • Novartis Investigative Site

    Plzen Bory, 301 00

    Withdrawn

  • Novartis Investigative Site

    Prague, 128 08

    Withdrawn

Other trials in Czechia

Guatemala2 sites, 2 recruiting

  • Novartis Investigative Site

    Guatemala City, GTM, 01011

    Recruiting

  • Novartis Investigative Site

    Guatemala City, 01010

    Recruiting

Other trials in Guatemala

Romania2 sites, 1 recruiting

  • Novartis Investigative Site

    Bucharest, 050152

    Recruiting

  • Novartis Investigative Site

    Timișoara, Timiș County, 300723

    Withdrawn

Other trials in Romania

Panama1 site, 1 recruiting

  • Novartis Investigative Site

    Panama City, Provincia de Panamá, 8185

    Recruiting

Other trials in Panama

About this study

Official title: Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate / Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma

The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.

  • The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.
  • The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.
Read the detailed description

This is a double-blind, randomized, active controlled, 2 period, 2 treatment (12 weeks duration each) cross-over multi-center study to evaluate the efficacy and safety of indacaterol (acetate)/ mometasone (furoate) compared to budesonide in terms of superiority in children from 6 to less than 12 years of age with asthma with FEV1 ≥50% of the predicted normal value for the participant.

The study duration of 37 weeks includes:

  • a screening period of up to 3 weeks
  • a run-in period of 3 weeks (run-in medication: Fluticasone propionate 50μg bid)
  • a first treatment period of 12 weeks (either with QMF149 75/40μg o.d or budesonide 200 μg o.d via Breezhaler)
  • a wash out period of 3 weeks (wash-out medication: Fluticasone propionate 50μg bid)
  • a second treatment period of 12 weeks (cross over of the 2 treatment groups with either QMF149 75/40μg o.d or budesonide 200 μg o.d via Breezhaler)
  • a safety follow-up period of 4 weeks during which the patient will be back on standard of care treatment as appropriate At the completion of the follow-up period, patient's safety information as well as survival status will be collected.
Conditions
Asthma
Being tested
QMF149, Budesonide
Keywords
Asthma, Pediatric, Breezhaler, QMF149, Budesonide
Medical subject headings
Asthma

What participants receive

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

  • QMF149Drug

    QMF149 75/40 μg o.d via Breezhaler

  • BudesonideDrug

    Budesonide 200 μg o.d via Breezhaler

Study groups in NCT05562466
Study groupRoleWhat they receive
QMF149ExperimentalQMF149 75/40μg
Receives: Drug: QMF149
BudesonideActive comparatorBudesonide 200μg o.d
Receives: Drug: Budesonide

What is being measured

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

  1. 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.

    Measured: Week 12 of each treatment period

Secondary outcomes (5)

  1. Change from baseline in ACQ-IA score

    The Asthma Control Questionnaire-Interview Administered (ACQ-IA) includes seven questions that assess nighttime awakenings, waking in the morning with symptoms, limitation of daily activities, shortness of breath, wheezing, forced expiratory volume in the first second (FEV1% predicted), and daily rescue bronchodilator use.

    Measured: At week 12 of each treatment period

  2. Change from baseline in average Morning and Evening PEFR

    Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration.

    Measured: Over 12 weeks of each treatment period

  3. Change from baseline in average rescue medication use

    Change from baseline in average rescue medication use (daytime, night-time, and daily) over 12 weeks of each treatment period

    Measured: Over 12 weeks of each treatment period

  4. Annual rate of asthma exacerbations

    Annual rate of asthma exacerbations by exacerbation category (any, moderate or severe, severe)

    Measured: Over 12 weeks with each treatment

  5. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Incidence of AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.

    Measured: From informed consent until 30 days after last dose of study treatment

Timeline

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

  1. First posted30 Sep 2022
  2. Study start11 May 2023
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion30 May 2028 (estimated)

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05562466
Sponsor's protocol ID
CQMF149G2301
Other IDs
2021-005591-19, 2022-501899-26-00
Status last verified
Oct 2026
First submitted
23 Sep 2022
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QMF149 and Budesonide in people with Asthma, run by Novartis Pharmaceuticals at 65 sites in 17 countries.

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 52 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in South Africa, Argentina, Italy, Spain, Greece and 12 more countries. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in trough FEV1 (time frame: Week 12 of each treatment period). 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 NCT05562466.

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 15 Oct 2026.

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