Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

NCT03199976 | Terminated Phase 4 Results DMC

• 2 other identifiers: TFS012015-002985-22
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Wheezy Bronchitis; Asthmatic Bronchitis; Wheezing; Obstruction Airway

Keywords

wheeze; shortness of breath

Outcome Measures

Primary Outcomes (1)

• Percentage of 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.

  Up to 48 weeks

Secondary Outcomes (3)

• Number of Participants With Unscheduled Physician Visits

  Up to 48 weeks

• Percentage of Days Participants Needed Rescue Medication

  Up to 48 weeks

• Number of Participants With Adverse Events

  Up to 48 weeks

Study Arms (3)

Tiotropium Bromide & Salbutamol

EXPERIMENTAL

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; Drug: Salbutamol

Fluticasone Propionate & Salbutamol

ACTIVE COMPARATOR

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: Fluticasone Propionate; Drug: Salbutamol

Salbutamol

ACTIVE COMPARATOR

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

Drug: Salbutamol

Interventions

Tiotropium Bromide DRUG

Tiotropium Bromide 2.5 µg/dose inhaled aerosol

Also known as: Spiriva Respimat

Tiotropium Bromide & Salbutamol

Fluticasone Propionate DRUG

Fluticasone Propionate 125 µg/dose inhaled aerosol

Also known as: Flixotide Evohaler

Fluticasone Propionate & Salbutamol

Salbutamol DRUG

Salbutamol 0.1 mg/dose inhaled aerosol

Also known as: Ventoline Evohaler

Fluticasone Propionate & Salbutamol; Salbutamol; Tiotropium Bromide & Salbutamol

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

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

Helsinki, FI-00029 HUS, Finland

Location

Related Publications (1)

• 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.

  PMID: 35942814 DERIVED

MeSH Terms

Conditions

Bronchiolitis; Respiratory Sounds; Airway Obstruction; Dyspnea

Interventions

Tiotropium Bromide; Fluticasone; Albuterol

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr Anne Kotaniemi-Syrjänen
• Organization: Helsinki University Central Hospital

anne.kotaniemi-syrjanen@hus.fi

+35894711

Study Officials

• Mika J Mäkelä, Professor

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 27, 2017
• Study Start: April 20, 2016
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2020
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)