TerminatedPhase 4

Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

Stopped: Subjects in the Salbutamol group discontinued the intervention more often due to troublesome respiratory symptoms

Finland80 participantsStarted 2016-04-20

Plain-language 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.

Who can participate

Age range6 Months – 35 Months

SexALL

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Percentage of Episode-Free Days

Timeframe: Up to 48 weeks

Trial details

NCT IDNCT03199976

SponsorHelsinki University Central Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-18

Results submitted2022-12-20

View on ClinicalTrials.gov More Wheezy Bronchitis trials