MedTrace Logo

Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

NCT03199976 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-09-19

Study results available
· View outcomes & findings →

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.

Conditions

  • Wheezy Bronchitis
  • Asthmatic Bronchitis
  • Wheezing
  • Obstruction Airway

Interventions

DRUG

Tiotropium Bromide

Tiotropium Bromide 2.5 µg/dose inhaled aerosol

DRUG

Fluticasone Propionate

Fluticasone Propionate 125 µg/dose inhaled aerosol

DRUG

Salbutamol

Salbutamol 0.1 mg/dose inhaled aerosol

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Mika J Mäkelä, Professor · Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-20
Primary Completion
2020-11-18
Completion
2020-11-18

Countries

  • Finland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03199976 on ClinicalTrials.gov