Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

February 13, 2021 updated by: Anne Kotaniemi-Syrjänen, Helsinki University Central Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, FI-00029 HUS
        • Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tiotropium Bromide & 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
Drug: Tiotropium Bromide
Tiotropium Bromide 2.5 µg/dose inhaled aerosol
Other Names:
  • Spiriva Respimat
Drug: Salbutamol
Salbutamol 0.1 mg/dose inhaled aerosol
Other Names:
  • Ventoline Evohaler
Active Comparator: Fluticasone Propionate & 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
Drug: Salbutamol
Salbutamol 0.1 mg/dose inhaled aerosol
Other Names:
  • Ventoline Evohaler
Drug: Fluticasone Propionate
Fluticasone Propionate 125 µg/dose inhaled aerosol
Other Names:
  • Flixotide Evohaler
Active Comparator: Salbutamol
Inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath
Drug: Salbutamol
Salbutamol 0.1 mg/dose inhaled aerosol
Other Names:
  • Ventoline Evohaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Episode-free days
Time Frame: 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.
Up to 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unscheduled physician visits
Time Frame: Up to 48 weeks
Effect on the number of unscheduled physician visits for episodes of wheeze and/or shortness of breath.
Up to 48 weeks
Rescue medication
Time Frame: Up to 48 weeks
Effect on the need for bronchodilative medication.
Up to 48 weeks
Adverse events
Time Frame: Up to 48 weeks
Occurrence of adverse events.
Up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Director: Mika J Mäkelä, Professor, Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2016

Primary Completion (Actual)

November 18, 2020

Study Completion (Actual)

November 18, 2020

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 13, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TFS01
  • 2015-002985-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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