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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

1 Sep 2023 → ongoing

Decision date (initial)

2023-05-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To show that indacaterol (acetate) / mometasone (furoate) (QMF149) is better when compared to budesonide in improving lung function (FEV1) at Week 12 of each treatment period.

Secondary objectives 3

1. Measure pediatric asthma symptoms (ACQ-IA), the peak air flow (PEFR) out of the lungs and the number of asthma flare ups over 12 weeks of each treatment period to assess if QMF149 is better than budesonide.
2. Measure and compare use of rescue medication (salbutamol/albuterol) over 12 weeks with each treatment through e-diary recordings of rescue usage (daily, night-time and daytime use).
3. Recording of medical problems patients have during the trial. Medical problems that happen in clinical trials are called “adverse events.” These problems may or may not be caused by the trial drug.

Conditions and MedDRA coding

Asthma

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001217-PIP01-11

Plan to share IPD

Yes

IPD plan description

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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Male and female children from 6 to less than 12 years of age with asthma for at least 1 year prior to study enrolment, inadequately controlled on low dose inhaled steroids.Or formerly adequately controlled on a combination therapy of low-dose steroids and add on medication but showing inadequate control after the initial, run in’ period of the trial when treated with a low dose inhaled steroid (fluticasone propionate) and qualifying for treatment with low dose inhaled corticosteroids plus a long-acting beta agonist.

Exclusion criteria 4

1. Prior intubation for asthma
2. Patients with severe asthma exacerbation requiring in the previous months either systemic steroids or hospitalization due to asthma or emergency room visit.
3. Subjects receiving pre-defined medications unless they undergo the required washout period prior to Treatment visit (Day 1) and follow the adjustment through the treatment period.
4. Patients who have had a respiratory tract infection as determined by the investigator within 4 weeks prior to Screening visit or between Screening and End of Run-In. Patients may be re-screened once, 4 weeks after recovery from their respiratory tract infection.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in improving lung function (FEV1) at Week 12 of each treatment period.

Secondary endpoints 3

1. Change from baseline in pediatric asthma symptoms (ACQ-IA), peak air flow out of the lungs (PEFR) score and the number of asthma flare ups at Week 12 of each treatment period.
2. Measure use of rescue medication changes (daytime, night-time, and daily) over 12 weeks of each treatment period.
3. All untoward effects happening in the study will be assessed to understand the safety of QMF149 in comparison with Budesonide based on clinical assessments, labs, ECGs and history.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel Town

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 20

Locations

9 EU/EEA countries · 31 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 362 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

27 submissions — initial application plus substantial / non-substantial modifications