Clinical trial for Asthma in Children
Official title Using a Smart Inhaler to Support Asthma Management in Adolescents With Intellectual and Developmental Disabilities
ClinicalTrials.gov ID: NCT06783101
What this study is testing
- What it's testing
- This study checks if smart inhalers are easy to use and if they help teens take their asthma medicine the right way to improve lung health.
- Who it's for
- Teens with asthma who also have intellectual or developmental disabilities, such as autism.
- What's involved
- Participants will use a special inhaler that gives feedback on how they breathe in the medicine, along with regular health checks.
- Time commitment
- The study involves using the device daily and attending scheduled visits for testing.
- Time commitment: about 8 weeks
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17
You may be able to join if
- Adolescents ages 10-17 years
- Diagnosis of mild-to-moderate intellectual disability: ICD-10: F70-F71 and/or diagnosis of developmental disability, including autism: ICD-10: F80-89
- Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma: ICD-10: J45.40-J45.909
- Parent/legal guardian is willing to answer questions about their child.
- Parent/legal guardian and adolescent must have the ability to understand study procedures and to comply with them for the entire length of the study
You likely can't join if
- Health status or any clinical conditions: Limited life expectancy, co-existing disease or other characteristics that precludes appropriate diagnosis...
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
See the full eligibility criteria
- Adolescents ages 10-17 years
- Diagnosis of mild-to-moderate intellectual disability: ICD-10: F70-F71 and/or diagnosis of developmental disability, including autism: ICD-10: F80-89
- Diagnosis of moderate-to-severe asthma or moderate or severe unspecified asthma: ICD-10: J45.40-J45.909
- Parent/legal guardian is willing to answer questions about their child.
- Parent/legal guardian and adolescent must have the ability to understand study procedures and to comply with them for the entire length of the study
- English or Spanish-speaking participants
- Not involved in other studies using digital inhalers
- Males and females of reproductive capability will be enrolled: contraception is not necessary or required.
- Participants must use any of the following MDIs (as indicated by the 510(k): Ventolin HFA, ProAir HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA, Atrovent HFA, Proventil HFA, Alvesco HFA, Dulera HFA, and...
- Health status or any clinical conditions: Limited life expectancy, co-existing disease or other characteristics that precludes appropriate diagnosis, treatment, or follow-up in the trial.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
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, but confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.