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Compares treatment options for Asthma
Official title 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
ClinicalTrials.gov ID: NCT05562466
What this study is testing
What is QMF149?
QMF149 is an investigational medicine, being studied as a potential treatment for asthma.
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 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.
- Phase 3: a large, late-stage study
- Time commitment: about 37 weeks
- Which group you join is decided by chance.
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
- 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...
- 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...
- Patient receiving daily treatment of stable low dose ICS alone (i.e. up to 100ug daily dose of fluticasone propionate DPI or equivalent) without...
You likely can't join if
- 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)...
- people receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day...
- 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...
See the full eligibility criteria
Who can 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%...
- 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...
- 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...
- 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 assigned by chance...
- 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...
- 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)...
- 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...
- 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.
What rules you out
- 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).
- people 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- people who have a clinically significant ECG abnormality reported before Visit 30 (End of Run-in).
- people 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...
- 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.
- people 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 how well it works (failure rate \<1%), for example hormone...
The study team makes the final eligibility decision.
Where it's taking place
- CABA, Buenos Aires, Argentina
- Mendoza, Mendoza Province, Argentina
- Rosario, Santa Fe Province, Argentina
- Graz, Austria
- Salzburg, Austria
- Sankt Pölten, Austria
- Sorocaba, São Paulo, Brazil
- Rousse, Bulgaria
- Sevlievo, Bulgaria
- Bucaramanga, Santander Department, Colombia
- Ibague, Tolima Department, Colombia
- Cali, Valle del Cauca Department, Colombia
- Plzen Bory, Czechia
- Prague, Czechia
- Athens, Greece
- Chaïdári, Greece
- Heraklion Crete., Greece
- Pátrai, Greece
- Thessaloniki, Greece
- Guatemala City, GTM, Guatemala
+ 37 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 37 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 CABA, Buenos Aires, Argentina; Mendoza, Mendoza Province, Argentina; Rosario, Santa Fe Province, Argentina; Graz, Austria; Salzburg, Austria; Sankt Pölten, Austria and 51 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.