Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

Phase 4

Completed

• Conditions: Wheezing; Obstruction Airway; Wheezy Bronchitis; Asthmatic Bronchitis
• Interventions: Drug: Tiotropium Bromide; Drug: Fluticasone Propionate; Drug: Salbutamol

• Registration Number: NCT03199976
• Lead Sponsor: Helsinki University Central Hospital

Brief 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 acethylcholine 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.

Study Timeline

• Study Start: 2016-04-20
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-27
• Primary Completion: 2020-11-18
• Study Completion: 2020-11-18
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-13
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiotropium Bromide & Salbutamol	Tiotropium Bromide	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
Tiotropium Bromide & Salbutamol	Salbutamol	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
Fluticasone Propionate & Salbutamol	Fluticasone Propionate	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
Salbutamol	Salbutamol	Inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath
Fluticasone Propionate & Salbutamol	Salbutamol	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

Primary Outcome Measures

Name	Time	Method
Percentage of Episode-Free Days	Up to 48 weeks	Effect on the episode-free days defined as the 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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Unscheduled Physician Visits	Up to 48 weeks	Effect on the number of unscheduled physician visits for episodes of wheeze and/or shortness of breath.
Percentage of Days Participants Needed Rescue Medication	Up to 48 weeks	Effect of the treatment on the need for bronchochilative and/or supplementary controller medication.
Number of Participants With Adverse Events	Up to 48 weeks	Occurrence of adverse events in treatment groups.

Trial Locations

Locations (1)

Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland; 🇫🇮 Helsinki, Finland