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Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

Primary Purpose

Wheezy Bronchitis, Asthmatic Bronchitis, Wheezing

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Tiotropium Bromide
Fluticasone Propionate
Salbutamol
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wheezy Bronchitis focused on measuring wheeze, shortness of breath

Eligibility Criteria

6 Months - 35 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Tiotropium Bromide & Salbutamol

Fluticasone Propionate & Salbutamol

Salbutamol

Arm Description

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

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

Inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Unscheduled physician visits
Effect on the number of unscheduled physician visits for episodes of wheeze and/or shortness of breath.
Rescue medication
Effect on the need for bronchodilative medication.
Adverse events
Occurrence of adverse events.

Full Information

First Posted
June 26, 2017
Last Updated
February 13, 2021
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03199976
Brief Title
Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
Official Title
Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 20, 2016 (Actual)
Primary Completion Date
November 18, 2020 (Actual)
Study Completion Date
November 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheezy Bronchitis, Asthmatic Bronchitis, Wheezing, Obstruction Airway
Keywords
wheeze, shortness of breath

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tiotropium Bromide & Salbutamol
Arm Type
Experimental
Arm Description
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
Arm Title
Fluticasone Propionate & Salbutamol
Arm Type
Active Comparator
Arm Description
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
Arm Title
Salbutamol
Arm Type
Active Comparator
Arm Description
Inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath
Intervention Type
Drug
Intervention Name(s)
Tiotropium Bromide
Other Intervention Name(s)
Spiriva Respimat
Intervention Description
Tiotropium Bromide 2.5 µg/dose inhaled aerosol
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate
Other Intervention Name(s)
Flixotide Evohaler
Intervention Description
Fluticasone Propionate 125 µg/dose inhaled aerosol
Intervention Type
Drug
Intervention Name(s)
Salbutamol
Other Intervention Name(s)
Ventoline Evohaler
Intervention Description
Salbutamol 0.1 mg/dose inhaled aerosol
Primary Outcome Measure Information:
Title
Episode-free days
Description
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.
Time Frame
Up to 48 weeks
Secondary Outcome Measure Information:
Title
Unscheduled physician visits
Description
Effect on the number of unscheduled physician visits for episodes of wheeze and/or shortness of breath.
Time Frame
Up to 48 weeks
Title
Rescue medication
Description
Effect on the need for bronchodilative medication.
Time Frame
Up to 48 weeks
Title
Adverse events
Description
Occurrence of adverse events.
Time Frame
Up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mika J Mäkelä, Professor
Organizational Affiliation
Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland
Official's Role
Study Director
Facility Information:
Facility Name
Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland
City
Helsinki
ZIP/Postal Code
FI-00029 HUS
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35942814
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.
Results Reference
derived

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Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

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