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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

Must not have

Use of ICS in combination with long-acting beta agonist or montelukast

History of life-threatening asthma requiring treatment with intubation or mechanical ventilation within the past 5 years

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

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I use a combination inhaler or montelukast for my asthma.

Select...

I have had severe asthma needing a breathing tube or machine in the last 5 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Gastroenteritis

Bladder transitional cell carcinoma recurrent

Non-cardiac chest pain

Spinal compression fracture

Calculus ureteric

Urinary retention

Hypokalemia

Aortic aneurysm

100%

80%

60%

40%

20%

Study treatment Arm

FSC + Tio

Tiotropium

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met