NCT03199976

Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Not accepted

Summary

This study evaluates the effect of intermittent tiotropium bromide and salbutamol as needed versus intermittent fluticasone propionate and salbutamol as needed, or solely, salbutamol as needed on episode-free days in infants and toddlers with recurrent episodes of wheeze and/or shortness of breath.

Detailed description

Up to 30% of all children suffer from episodic wheeze or shortness of breath, i.e. asthmatic bronchitis, during the first three years of life. The condition is usually induced by viral respiratory infections, and short-acting beta-agonists are recommended as a monotherapy for symptoms unless there are at least four physician-confirmed episodes of wheeze or shortness of breath, or three episodes plus asthma risk factors. There is a current need for new therapeutic agents to treat asthmatic bronchitis in young children. In viral-induced wheeze, increased parasympathetic nerve activity results in increased acetylcholine release from nerve endings. Tiotropium bromide, an inhaled anticholinergic agent, prevents the acetylcholine function and achieves mild bronchodilatation and decrease in mucus secretion from the submucosal glands. The aim of the study is to find out the effect of intermittent tiotropium bromide and salbutamol as needed versus intermittent fluticasone propionate and salbutamol as needed, or solely, salbutamol as needed on episode-free days in infants and toddlers with recurrent episodes of wheeze and/or shortness of breath. Episode-free days are defined as those days during which there are no symptoms of wheeze and/or shortness of breath, no unscheduled medical visits for wheeze and/or shortness of breath, and no use of rescue or supplementary controller medications.

Conditions

• Wheezy Bronchitis
• Asthmatic Bronchitis
• Wheezing
• Obstruction Airway

Interventions

Type	Name	Description
DRUG	Tiotropium Bromide	Tiotropium Bromide 2.5 µg/dose inhaled aerosol
DRUG	Fluticasone Propionate	Fluticasone Propionate 125 µg/dose inhaled aerosol
DRUG	Salbutamol	Salbutamol 0.1 mg/dose inhaled aerosol

Timeline

• Start date: 2016-04-20
• Primary completion: 2020-11-18
• Completion: 2020-11-18
• First posted: 2017-06-27
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: Finland