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NCT05562466
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
Conditions: Asthma
Sex: All
Ages: 6 Years – 11 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 200
Sponsor: Novartis Pharmaceuticals
Location: Novartis Investigative Site CABA Buenos Aires
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.
* 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.
Eligibility Criteria
Inclusion Criteria
1. Male or female children ≥ 6 years and \24h) or emergency room visit (≤24 hours).
3. 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.
4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
5. 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.
6. 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 \
Source: ClinicalTrials.gov (NCT05562466). StuddyBuddy aggregates publicly available trial information.