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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
EU CTIS ID: 2022-501899-26-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Prior intubation for asthma
- Patients with severe asthma exacerbation requiring in the previous months either systemic steroids or hospitalization due to asthma or emergency room visit.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- Mexico
- Vietnam
- Argentina
- Panama
- Colombia
- Peru
- Guatemala
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa; Mexico; Vietnam; Argentina; Panama; Colombia and 2 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 EU CTIS; the study team decides eligibility.