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Anticholinergic

Tiotropium for Childhood Asthma (TioNAAP Trial)

Phase 2

Recruiting

Led By Gerardo A Vazquez Garcia, MD

Research Sponsored by Nemours Children's Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children ages 6 to 11 years with controlled mild nonatopic persistent physician diagnosed asthma

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the subjects will answer the daily digital diary every day from day 1 until the completion of the study at 14 weeks.

Awards & highlights

TioNAAP Trial Summary

This trial will compare the safety of tiotropium monotherapy to that of ICS in children with nonatopic mild persistent asthma.

Who is the study for?

This trial is for children aged 6 to 11 with mild, controlled nonatopic asthma—meaning they don't have allergies like hay fever, eczema or food allergies and their blood tests show low levels of certain immune cells and antibodies. They should be currently treated with as-needed albuterol, low-dose inhaled steroids or daily montelukast.Check my eligibility

What is being tested?

The study compares tiotropium monotherapy—a long-acting inhaler medication—with inhaled corticosteroids (ICS) over a period of six weeks. It aims to see if tiotropium alone can manage asthma symptoms without the need for ICS in children who don't respond well to steroids due to lack of allergies.See study design

What are the potential side effects?

Tiotropium may cause dry mouth, sore throat, coughing and headache. In some cases, it might lead to more serious effects like difficulty breathing or increased heart rate but these are less common.

TioNAAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child, aged 6-11, has mild, non-allergic asthma diagnosed by a doctor.

TioNAAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the subjects will answer the daily digital diary every day from day 1 until the completion of the study at 14 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the subjects will answer the daily digital diary every day from day 1 until the completion of the study at 14 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the subjects will answer the daily digital diary every day from day 1 until the completion of the study at 14 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in c-ACT score between standard therapy (inhaled corticosteroids) and tiotropium

Secondary outcome measures

Complete Blood Count with Differential (CBC)

Daily Digital Diary

Fractional Exhaled Nitric Oxide (FeNO)

+1 more

Side effects data

From 2009 Phase 4 trial • 342 Patients • NCT00784550

14%

Chronic obstructive pulmonary disease

Headache

Spinal compression fracture

Urinary retention

Non-cardiac chest pain

Calculus ureteric

Gastroenteritis

Bladder transitional cell carcinoma recurrent

Hypokalemia

Aortic aneurysm

100%

80%

60%

40%

20%

Study treatment Arm

FSC + Tio

Tiotropium

TioNAAP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Tiotropium armExperimental Treatment1 Intervention

Subjects on this arm will start the study on tiotropium for 6 weeks. Received prescribed asthma controller medication for 2 weeks " washout" and complete 6 week on the prescribed asthma controller medication.

Group II: ICS armActive Control1 Intervention

Subjects on this arm will start the study on the prescribed asthma medication for 6 weeks. Received prescribed asthma controller medication for 2 weeks " washout" and complete 6 week on Tiotropium.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tiotropium

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor

124 Previous Clinical Trials

18,105 Total Patients Enrolled

Gerardo A Vazquez Garcia, MDPrincipal InvestigatorNemours

Media Library

Tiotropium Bromide (Anticholinergic) Clinical Trial Eligibility Overview. Trial Name: NCT04990167 — Phase 2

Childhood Asthma Research Study Groups: ICS arm, Tiotropium arm

Childhood Asthma Clinical Trial 2023: Tiotropium Bromide Highlights & Side Effects. Trial Name: NCT04990167 — Phase 2

Tiotropium Bromide (Anticholinergic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04990167 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially join this research endeavor?

"This asthma research is seeking 26 children within the age range 6 to 12 who meet the following criteria: their Childhood Asthma Control Test score must be higher than 19, signifying controlled breathing issues."

Answered by AI

Is enrollment for this research endeavor still open?

"This clinical trial is no longer recruiting, as indicated on the official page hosted by clinicaltrials.gov. The initial posting of this study was dated August 1st 2021 and it stopped accepting applications three days later. However, there are still 326 other active studies searching for patients to partake in their trials at present."

Answered by AI

How does Tiotropium arm appear to affect the safety of patients?

"Tiotropium arm has been assessed to have a safety rating of 2 on the 1-3 scale, as this is currently in its Phase 2 trial stage with preliminary evidence supporting safety but no data backing efficacy."

Answered by AI

Is this an unprecedented research endeavor?

"At present, two clinical trials for Tiotropium arm are running across two nations and one city. The primary research into this pharmaceutical was sponsored by Boehringer Ingelheim in 2019 with a sample size of 50 patients completing Phase 4 drug approval. To date, 271 studies have been conducted since that initial trial 3 years ago."

Answered by AI

Is there an age limit for enrollment in this clinical trial, and if so, what is it?

"This clinical trial seeks to enroll children aged 6-12. Additionally, there are 119 studies that cater to the needs of minors and 200 trials serving seniors 65 or older."

Answered by AI

What condition is the Tiotropium arm commonly prescribed to address?

"Tiotropium is primarily used to help with bronchoconstriction and other conditions such as chronic obstructive pulmonary disease, chronic bronchitis, and acute bronchitis."

Answered by AI

How many participants are being admitted to this research project?

"At the moment, recruitment for this trial on clinicaltrials.gov is suspended; it was initially posted August 1st 2021 and last updated three days later. For those seeking other studies related to asthma, 324 trials are actively signing up patients while two others focus specifically on Tiotropium arm enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tiotropium vs. Inhaled Corticosteroids in Children With Nonatopic Asthma Pilot Study (TioNAAP)

Gerardo Vazquez Garcia 2022. "Tiotropium vs. Inhaled Corticosteroids in Children With Nonatopic Asthma Pilot Study (TioNAAP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04990167.

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