Clinical trial NCT03199976: Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
Official title: Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Wheezy Bronchitis
Asthmatic Bronchitis
Wheezing
Obstruction Airway
Keywords: wheeze
shortness of breath
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Episode-Free Days
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: Number of Participants With Unscheduled Physician Visits
timeFrame: Up to 48 weeks
measure: Percentage of Days Participants Needed Rescue Medication
timeFrame: Up to 48 weeks
measure: Number of Participants With Adverse Events
timeFrame: Up to 48 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland
Study officials:
affiliation: Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland
name: Mika J Mäkelä, Professor
role: STUDY_DIRECTOR
References:
citation: Kotaniemi-Syrjanen A, Klemola T, Koponen P, Jauhola O, Aito H, Malmstrom K, Malmberg LP, Rahiala E, Sarna S, Pelkonen AS, Makela MJ. Intermittent Tiotropium Bromide for Episodic Wheezing: A Randomized Trial. Pediatrics. 2022 Sep 1;150(3):e2021055860. doi: 10.1542/peds.2021-055860.