Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

Helsinki University Central Hospital (HUCH)

Status and phase: Terminated; Phase 4

Conditions: Wheezing; Obstruction Airway; Wheezy Bronchitis; Asthmatic Bronchitis

Treatments: Drug: Salbutamol; Drug: Fluticasone Propionate; Drug: Tiotropium Bromide

Study type: Interventional

Funder types: Other

Identifiers

NCT03199976

2015-002985-22 (EudraCT Number)

TFS01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 6 to 35 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children at the age of 6 to 35 months.
2. Two to four physician-confirmed episodes of wheeze and/or shortness of breath.
3. Parents/legal representatives with sufficient written and spoken skills in Finnish language.

Exclusion criteria

1. Birth before 36th week of gestation.
2. Suspected/diagnosed chronic parenchymal lung disease or a structural airway defect, or a history of thoracotomy with pulmonary resection.
3. A history of congenital or acquired heart disease, including any unstable or life-threatening cardiac arrhythmia.
4. Constipation with a need of regular medication, or a diagnosed/suspected structural defect in the gastrointestinal tract.
5. A history of malignancy, or other significant chronic disorder, disease, or defect.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Tiotropium Bromide & Salbutamol

Experimental group

Description:

Inhaled Tiotropium Bromide 5 µg once a day, beginning at the onset of an upper respiratory tract infection and continuing for 7 to 14 days as needed, and inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath

Treatment:

Drug: Tiotropium Bromide

Drug: Salbutamol

Fluticasone Propionate & Salbutamol

Active Comparator group

Description:

Inhaled Fluticasone Propionate 125 µg twice a day, beginning at the onset of an upper respiratory tract infection and continuing for 7 to 14 days as needed, and inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath

Treatment:

Drug: Fluticasone Propionate

Drug: Salbutamol

Salbutamol

Active Comparator group

Description:

Inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath

Treatment:

Drug: Salbutamol