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Efficacy of Intermittent Tiotropium in Early Childhood Wheezing

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ClinicalTrials.gov Identifier: NCT03199976
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Anne Kotaniemi-Syrjänen, Helsinki University Central Hospital

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.

Condition or disease Intervention/treatment Phase
Wheezy Bronchitis Asthmatic Bronchitis Wheezing Obstruction Airway Drug: Tiotropium Bromide Drug: Fluticasone Propionate Drug: Salbutamol Phase 4

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  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
Actual Study Start Date : April 20, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022


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 Name: Spiriva Respimat

Drug: Salbutamol
Salbutamol 0.1 mg/dose inhaled aerosol
Other Name: 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: Fluticasone Propionate
Fluticasone Propionate 125 µg/dose inhaled aerosol
Other Name: Flixotide Evohaler

Drug: Salbutamol
Salbutamol 0.1 mg/dose inhaled aerosol
Other Name: Ventoline 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 Name: Ventoline Evohaler




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Rescue medication [ Time Frame: Up to 48 weeks ]
    Effect on the need for bronchodilative medication.

  3. Adverse events [ Time Frame: Up to 48 weeks ]
    Occurrence of adverse events.



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Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199976


Contacts
Contact: Anne Kotaniemi-Syrjänen, MD, PhD +358-50-4388404 anne.kotaniemi-syrjanen@hus.fi
Contact: Mika J Mäkelä, Professor +358-9-4711 mika.makela@hus.fi

Locations
Finland
Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland Recruiting
Helsinki, Finland, FI-00029 HUS
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Study Director: Mika J Mäkelä, Professor Skin and Allergy Hospital, Helsinki University Hospital, Helsinki, Finland

Responsible Party: Anne Kotaniemi-Syrjänen, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03199976     History of Changes
Other Study ID Numbers: TFS01
2015-002985-22 ( EudraCT Number )
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anne Kotaniemi-Syrjänen, Helsinki University Central Hospital:
wheeze
shortness of breath

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Respiratory Sounds
Bronchiolitis
Airway Obstruction
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Insufficiency
Respiration Disorders
Fluticasone
Tiotropium Bromide
Albuterol
Bromides
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Parasympatholytics