A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
Recruiting · 40 sites across 17 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Ages 12 to 17 (inclusive) when signing consent/assent.
- •Has asthma diagnosed at least 1 year before Visit 0 (as defined by NIH 2020).
- •Uses daily inhaled corticosteroids (ICS) and long-acting beta2-agonist (LABA) medicine for at least 12 weeks before Visit 0, with no changes to maintenance asthma medicines in the 6 weeks before Visit 0 (including keeping fluticasone propionate dose >250 to <=500 mcg/day, or equivalent).
- •Has inadequately controlled asthma at Visit 1 (ACQ-6 score ≥1.5) even with ICS/LABA.
- •At Visit 1, lung breathing test results meet: best pre-bronchodilator FEV1 >40% to <=90% predicted, and FEV1 increases by at least 12% after albuterol/salbutamol.
🚫 You may not be able to join if…
- •Pneumonia shown on a chest X-ray in the 6 weeks before Visit 1.
- •An asthma flare in the 6 weeks before Visit 1 that required changing maintenance asthma therapy and/or using systemic corticosteroids for at least 3 days.
- •A history of life-threatening asthma.
- •Has active lung diseases or lung problems other than asthma (examples given include active tuberculosis, significant bronchiectasis, pneumonia).
- •Is a current smoker, or used recreational inhaled products (with or without nicotine, including vaping) within 12 months before Visit 1.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 12–17
- ✓Have COPD (chronic lung disease) or Asthma
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT05757102 · Locations: Alabama · Arizona · California · Colorado · Florida · Georgia · Illinois · Kentucky · Missouri · Montana · New York · Ohio · Oklahoma · South Carolina · Texas · Queensland · Western Australia