Actively Recruiting
Double-blind, Randomized, Active-controlled, Two-way Cross-over Study to Evaluate the Efficacy and Safety of QMF149 Compared to Budesonide in Children 6 to Less Than 12 Years of Age With Asthma
Led by Novartis Pharmaceuticals · Updated on 2026-06-05
200
Participants Needed
62
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of QMF149, a combination of indacaterol acetate and mometasone furoate, compared to budesonide in children aged 6 to less than 12 years who have asthma. The study is a double-blind, randomized, active-controlled, two-period crossover trial designed to assess which treatment better improves lung function as measured by FEV1. This Phase 3 trial includes children with asthma who have a predicted FEV1 of 50% or more and aims to gather detailed safety and efficacy data over a structured timeline. The trial lasts up to 37 weeks and includes several distinct periods: a screening phase of up to 3 weeks, a 3-week run-in period with a specific inhaled corticosteroid (Fluticasone propionate 50 mcg twice daily), followed by two 12-week treatment periods where participants receive either QMF149 75/40 mcg once daily or budesonide 200 mcg once daily via Breezhaler. Between these treatment periods is a 3-week wash-out phase using the same run-in medication. After all treatment phases, there is a 4-week safety follow-up period where patients return to their standard care. Participants regularly visit the study center approximately every 3 to 6 weeks for assessments including lung function tests, asthma control questionnaires, and monitoring of adverse events. Parents or guardians assist with medication compliance and diary entries. The study measures changes in lung function, asthma symptoms, rescue medication use, and exacerbation rates. Safety is closely monitored throughout, including during the follow-up period. The total commitment for each participant covers the entire 37-week duration of the study.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female children aged 6 to less than 12 years at randomization
- Parent or legal guardian able to attend visits and assist with study procedures and medication compliance
- Confirmed asthma diagnosis for at least 12 months before study enrollment
- Informed consent from parent/legal guardian and assent from child as required
- Receiving stable low dose inhaled corticosteroids alone or with one additional controller before run-in
- Symptomatic asthma at randomization as defined by ACQ-IA score
- Pre-bronchodilator FEV1 at least 50% of predicted normal at start and end of run-in
- Ability to demonstrate correct inhaler technique with Breezhaler and complete spirometry
- Parent/legal guardian to complete study diaries and attend all visits
- Negative COVID-19 test within 3 days before randomization
- For optional pharmacokinetics, weight of at least 25 kg at screening
You will not qualify if you...
- Prior intubation for asthma
- Severe asthma exacerbation in the past month requiring systemic steroids, hospitalization, or emergency visit
- Use of prohibited medications without required washout
- Use of other investigational drugs within 5 half-lives or 30 days before enrollment
- History of malignancy within past 5 years (except certain skin and cervical cancers)
- Impaired renal function or urinary abnormalities
- Respiratory tract infection within 4 weeks before screening or between screening and run-in
- Chronic respiratory conditions other than asthma that affect study participation
- Clinically significant oropharyngeal candidiasis at screening
- History of chronic lung disease other than asthma
- Long QT syndrome or prolonged QTc interval
- Clinically significant ECG or lab abnormalities before run-in end
- Medical or surgical conditions affecting drug metabolism or participant safety
- Inability to comply with treatment or study procedures
- Immediate family member of study personnel
- Recent use of theophylline or non-approved experimental asthma drugs
- Use of long-acting muscarinic antagonists within 3 months before screening
- Unstable disease within 4 weeks before screening
- Hypersensitivity to study drugs or excipients including lactose
- Type I diabetes or uncontrolled Type II diabetes
- Use of prohibited asthma or other medications
- Recent or changing allergy immunotherapy
- Female patients of childbearing potential not agreeing to abstinence or effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 3 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening assessments
Duration - 3 weeks
Participants receive Fluticasone propionate 50μg twice daily to stabilize their asthma before treatment periods begin.
Visits as needed to monitor run-in medication
Duration - 12 weeks
Participants receive either QMF149 75/40μg once daily or Budesonide 200μg once daily via Breezhaler in a double-blind manner.
Regular visits throughout 12 weeks for treatment and assessments
Duration - 3 weeks
Participants receive Fluticasone propionate 50μg twice daily to clear previous treatment effects before the next treatment period.
Visits as needed during wash-out
Duration - 12 weeks
Participants cross over to the alternate treatment, receiving either QMF149 75/40μg once daily or Budesonide 200μg once daily via Breezhaler.
Regular visits throughout 12 weeks for treatment and assessments
Duration - 4 weeks
Participants are monitored for safety while receiving standard of care treatment as appropriate after completing study treatments.
1 to 2 visits for safety assessments and survival status
Trial Site Locations
Total: 62 locations
1
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1122AAK
Actively Recruiting
2
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1414AIF
Actively Recruiting
3
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1425BEN
Actively Recruiting
4
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
5
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina, S2000JKR
Actively Recruiting
6
Novartis Investigative Site
Mendoza, Argentina, 5500
Actively Recruiting
7
Novartis Investigative Site
Graz, Austria, 8036
Withdrawn
8
Novartis Investigative Site
Salzburg, Austria, 5020
Withdrawn
9
Novartis Investigative Site
Sankt Pölten, Austria, 3100
Withdrawn
10
Novartis Investigative Site
Rousse, Bulgaria, 7002
Actively Recruiting
11
Novartis Investigative Site
Sevlievo, Bulgaria, 5400
Actively Recruiting
12
Novartis Investigative Site
Bucaramanga, Santander Department, Colombia, 680001
Actively Recruiting
13
Novartis Investigative Site
Ibague, Tolima Department, Colombia, 730006
Actively Recruiting
14
Novartis Investigative Site
Cali, Valle del Cauca Department, Colombia, 760001
Actively Recruiting
15
Novartis Investigative Site
Plzen Bory, Czechia, 301 00
Withdrawn
16
Novartis Investigative Site
Prague, Czechia, 128 08
Withdrawn
17
Novartis Investigative Site
Athens, Greece, 115 27
Actively Recruiting
18
Novartis Investigative Site
Chaïdári, Greece, 124 62
Withdrawn
19
Novartis Investigative Site
Heraklion Crete., Greece, 715 00
Actively Recruiting
20
Novartis Investigative Site
Pátrai, Greece, 265 04
Actively Recruiting
21
Novartis Investigative Site
Thessaloniki, Greece, 546 42
Actively Recruiting
22
Novartis Investigative Site
Guatemala City, GTM, Guatemala, 01011
Actively Recruiting
23
Novartis Investigative Site
Guatemala City, Guatemala, 01010
Actively Recruiting
24
Novartis Investigative Site
Budapest, Hungary, 1033
Actively Recruiting
25
Novartis Investigative Site
Gödöllő, Hungary, 2100
Actively Recruiting
26
Novartis Investigative Site
Szeged, Hungary, 6720
Actively Recruiting
27
Novartis Investigative Site
Szigetvár, Hungary, 7900
Actively Recruiting
28
Novartis Investigative Site
Brescia, BS, Italy, 25123
Withdrawn
29
Novartis Investigative Site
Catania, CT, Italy, 95123
Actively Recruiting
30
Novartis Investigative Site
Florence, FI, Italy, 50139
Withdrawn
31
Novartis Investigative Site
Pavia, PV, Italy, 27100
Withdrawn
32
Novartis Investigative Site
Roma, RM, Italy, 00161
Actively Recruiting
33
Novartis Investigative Site
Naples, Italy, 80138
Actively Recruiting
34
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44100
Actively Recruiting
35
Novartis Investigative Site
Guadalajara, Jalisco, Mexico, 44130
Actively Recruiting
36
Novartis Investigative Site
San Juan del Río, Querétaro, Mexico, 76800
Actively Recruiting
37
Novartis Investigative Site
Villahermosa, Tabasco, Mexico, 86035
Actively Recruiting
38
Novartis Investigative Site
Querétaro, Mexico, 76000
Actively Recruiting
39
Novartis Investigative Site
Panama City, Panama, 8185
Actively Recruiting
40
Novartis Investigative Site
Lisbon, Portugal, 1649-035
Actively Recruiting
41
Novartis Investigative Site
Lisbon, Portugal, 1998-018
Actively Recruiting
42
Novartis Investigative Site
Porto, Portugal, 4099-001
Withdrawn
43
Novartis Investigative Site
Porto, Portugal, 4100-180
Actively Recruiting
44
Novartis Investigative Site
Timișoara, Timiș County, Romania, 300723
Withdrawn
45
Novartis Investigative Site
Bucharest, Romania, 050152
Actively Recruiting
46
Novartis Investigative Site
Bloemfontein, Free State, South Africa, 9301
Actively Recruiting
47
Novartis Investigative Site
Pretoria, Gauteng, South Africa, 0181
Actively Recruiting
48
Novartis Investigative Site
Raslouw Centurion, Gauteng, South Africa, 0157
Actively Recruiting
49
Novartis Investigative Site
Cape Town, Western Cape, South Africa, 7130
Withdrawn
50
Novartis Investigative Site
George, Western Cape, South Africa, 6529
Withdrawn
51
Novartis Investigative Site
Cape Town, Western Province, South Africa, 7700
Actively Recruiting
52
Novartis Investigative Site
Cape Town, South Africa, 7531
Actively Recruiting
53
Novartis Investigative Site
Centurion, South Africa, 0157
Actively Recruiting
54
Novartis Investigative Site
Esplugues, Barcelona, Spain, 08950
Actively Recruiting
55
Novartis Investigative Site
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
56
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
57
Novartis Investigative Site
Córdoba, Spain, 14004
Actively Recruiting
58
Novartis Investigative Site
Madrid, Spain, 28034
Actively Recruiting
59
Novartis Investigative Site
Málaga, Spain, 29011
Actively Recruiting
60
Novartis Investigative Site
Haiphong, Vietnam, 180000
Actively Recruiting
61
Novartis Investigative Site
Hanoi, Vietnam, 100000
Actively Recruiting
62
Novartis Investigative Site
Ho Chi Minh City, Vietnam, 700000
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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