Actively Recruiting
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
Led by Novartis Pharmaceuticals · Updated on 2026-05-05
200
Participants Needed
62
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to less than 12 years at randomization
- Parent or guardian willing and able to attend visits and assist with study procedures
- Diagnosed with asthma for at least 12 months according to guidelines
- Written informed consent from parent/guardian and assent from child as applicable
- Receiving stable low dose inhaled corticosteroids (ICS) alone or with one additional controller before run-in
- Symptomatic asthma defined by ACQ-IA score 1.5 at randomization
- Pre-bronchodilator FEV1 5% of predicted normal at start and end of run-in
- Demonstrated bronchodilator responsiveness at run-in visit
- Able to properly use Breezhaler inhaler and complete spirometry
- Parent/legal guardian able to complete e-Diary entries and attend all visits
- Negative COVID-19 test within 3 days before randomization
- For optional pharmacokinetics, participant must weigh at least 25 kg at screening
You will not qualify if you...
- History of prior intubation for asthma
- Severe asthma exacerbation requiring systemic steroids, hospitalization, or emergency visit within past month
- Use of prohibited medications without required washout before treatment
- Use of other investigational drugs within 5 half-lives or 30 days prior to enrollment
- History of malignancy within past 5 years except certain skin or cervical cancers
- Impaired kidney function or abnormal urinary findings as judged by investigator
- Respiratory tract infection within 4 weeks before or during run-in visit
- Chronic respiratory conditions other than asthma that may interfere with study
- Clinically significant oropharyngeal candidiasis at or before run-in visit
- Chronic lung diseases other than asthma such as cystic fibrosis, COPD, or tuberculosis
- History of long QT syndrome or prolonged QTc interval
- Clinically significant ECG or laboratory abnormalities before run-in
- Medical or surgical conditions affecting drug metabolism or study safety
- Inability to comply with study treatment or protocol due to medical or mental conditions
- Immediate family members of study staff
- Recent use of theophylline or experimental asthma drugs not recommended in guidelines
- Use of long-acting muscarinic antagonists as maintenance within 3 months prior to screening
- Unstable disease within 4 weeks prior to screening that may risk safety or confound results
- Hypersensitivity to study drugs or excipients including lactose
- Type I diabetes or uncontrolled Type II diabetes prior to run-in
- Use of prohibited asthma or non-asthma medications as per protocol
- Recent immunotherapy or allergy desensitization expected to change during study
- Female patients of childbearing potential not agreeing to abstinence or effective contraception methods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively Recruiting
8
Novartis Investigative Site
Salzburg, Austria, 5020
Actively Recruiting
9
Novartis Investigative Site
Sankt Pölten, Austria, 3100
Actively Recruiting
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
Actively Recruiting
16
Novartis Investigative Site
Prague, Czechia, 128 08
Actively Recruiting
17
Novartis Investigative Site
Athens, Greece, 115 27
Actively Recruiting
18
Novartis Investigative Site
Chaïdári, Greece, 124 62
Actively Recruiting
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
Centurion, Gauteng, South Africa, 0157
Actively Recruiting
48
Novartis Investigative Site
Pretoria, Gauteng, South Africa, 0181
Actively Recruiting
49
Novartis Investigative Site
Raslouw Centurion, Gauteng, South Africa, 0157
Actively Recruiting
50
Novartis Investigative Site
Cape Town, Western Cape, South Africa, 7130
Actively Recruiting
51
Novartis Investigative Site
George, Western Cape, South Africa, 6529
Actively Recruiting
52
Novartis Investigative Site
Cape Town, Western Province, South Africa, 7700
Actively Recruiting
53
Novartis Investigative Site
Cape Town, South Africa, 7531
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
CONTACT
N
Novartis Pharmaceuticals
CONTACT
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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