Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

Wheezing Clinical Trial

Official title:

Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199976
• Other study ID #: TFS01
• Secondary ID: 2015-002985-22
• Status: Completed
• Phase: Phase 4
• Start date: April 20, 2016
• Est. completion date: November 18, 2020

Study information

• Verified date: February 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 18, 2020
• Est. primary completion date: November 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Asthmatic Bronchitis
• Bronchiolitis
• Bronchitis
• Obstruction Airway
• Respiratory Sounds
• Wheezing
• Wheezy Bronchitis

Intervention

Drug:
• Tiotropium Bromide
Tiotropium Bromide 2.5 µg/dose inhaled aerosol
• Fluticasone Propionate
Fluticasone Propionate 125 µg/dose inhaled aerosol
• Salbutamol
Salbutamol 0.1 mg/dose inhaled aerosol

Locations

Country	Name	City	State
Finland	Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Episode-free days	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.	Up to 48 weeks
Secondary	Unscheduled physician visits	Effect on the number of unscheduled physician visits for episodes of wheeze and/or shortness of breath.	Up to 48 weeks
Secondary	Rescue medication	Effect on the need for bronchodilative medication.	Up to 48 weeks
Secondary	Adverse events	Occurrence of adverse events.	Up to 48 weeks