A Phase 4 interventional study of Tiotropium Bromide and Fluticasone Propionate in Wheezy Bronchitis, Asthmatic Bronchitis and Wheezing, sponsored by Helsinki University Central Hospital. Terminated at 1 site in Finland. Open to participants aged 6 Months to 35 Months. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Helsinki University Central Hospital · Phase 4, Interventional, and Treatment
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.
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 acetylcholine 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.
Exclusion Criteria:
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
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
Inhaled Salbutamol 0.2 mg 4 to 6 times a day as needed for wheeze and shortness of breath
Drug: Salbutamol
Tiotropium Bromide 2.5 µg/dose inhaled aerosol
Also known as: Spiriva Respimat
Fluticasone Propionate 125 µg/dose inhaled aerosol
Also known as: Flixotide Evohaler
Salbutamol 0.1 mg/dose inhaled aerosol
Also known as: Ventoline Evohaler
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.
Time frame: Up to 48 weeks
Number of Participants With Unscheduled Physician Visits
Effect on the number of unscheduled physician visits for episodes of wheeze and/or shortness of breath.
Time frame: Up to 48 weeks
Percentage of Days Participants Needed Rescue Medication
Effect of the treatment on the need for bronchochilative and/or supplementary controller medication.
Time frame: Up to 48 weeks
Number of Participants With Adverse Events
Occurrence of adverse events in treatment groups.
Time frame: Up to 48 weeks
| Milestone | Tiotropium Bromide & Salbutamol | Fluticasone Propionate & Salbutamol | Salbutamol |
|---|---|---|---|
| Started | 27 | 25 | 28 |
| Completed | 23 | 18 | 14 |
| Not completed | 4 | 7 | 14 |
| Withdrew: Lack of efficacy | 3 | 6 | 13 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 |
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.
| percentage of episode-free days | Tiotropium Bromide & Salbutamol | Fluticasone Propionate & Salbutamol | Salbutamol |
|---|---|---|---|
| Percentage of Episode-Free Days | 97 (93 to 99) | 87 (78 to 93) | 88 (79 to 95) |
Effect on the number of unscheduled physician visits for episodes of wheeze and/or shortness of breath.
| Participants | Tiotropium Bromide & Salbutamol | Fluticasone Propionate & Salbutamol | Salbutamol |
|---|---|---|---|
| Number of Participants With Unscheduled Physician Visits | 10 | 10 | 14 |
Effect of the treatment on the need for bronchochilative and/or supplementary controller medication.
| percentage of days | Tiotropium Bromide & Salbutamol | Fluticasone Propionate & Salbutamol | Salbutamol |
|---|---|---|---|
| Percentage of Days Participants Needed Rescue Medication | 2 (0 to 7) | 13 (6 to 21) | 12 (6 to 20) |
Occurrence of adverse events in treatment groups.
| Participants | Tiotropium Bromide & Salbutamol | Fluticasone Propionate & Salbutamol | Salbutamol |
|---|---|---|---|
| Number of Participants With Adverse Events | 23 | 25 | 26 |
Collected over 48 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tiotropium Bromide & Salbutamol | 0/27 (0%) | 4/27 (14.8%) | 19/27 (70.4%) |
| Fluticasone Propionate & Salbutamol | 0/25 (0%) | 3/25 (12%) | 22/25 (88%) |
| Salbutamol | 0/28 (0%) | 3/28 (10.7%) | 23/28 (82.1%) |
| Event | Tiotropium Bromide & Salbutamol | Fluticasone Propionate & Salbutamol | Salbutamol |
|---|---|---|---|
| Wheezy bronchitisInfections and infestations | 3/27 | 1/25 | 1/28 |
| Wheezy bronchitis and laryngitisInfections and infestations | 0/27 | 1/25 | 0/28 |
| Wheezy bronchitis and anaphylaxis to cashewInfections and infestations | 0/27 | 1/25 | 0/28 |
| PneumoniaInfections and infestations | 1/27 | 0/25 | 0/28 |
| Wheezy bronchitis and pneumoniaInfections and infestations | 0/27 | 0/25 | 1/28 |
| EnteritisInfections and infestations | 0/27 | 0/25 | 1/28 |
| Event | Tiotropium Bromide & Salbutamol | Fluticasone Propionate & Salbutamol | Salbutamol |
|---|---|---|---|
| Otitis mediaInfections and infestations | 16/27 | 9/25 | 12/28 |
| Upper respiratory tract infectionInfections and infestations | 13/27 | 13/25 | 9/28 |
| Wheezy bronchitisInfections and infestations | 7/27 | 7/25 | 12/28 |
| ConjunctivitisInfections and infestations | 4/27 | 1/25 | 7/28 |
| EnteritisInfections and infestations | 3/27 | 3/25 | 2/28 |
| Minor traumaInjury, poisoning and procedural complications | 2/27 | 3/25 | 2/28 |
| EczemaSkin and subcutaneous tissue disorders | 1/27 | 3/25 | 1/28 |
| TonsillitisInfections and infestations | 1/27 | 1/25 | 3/28 |
| ExanthemaSkin and subcutaneous tissue disorders | 1/27 | 2/25 | 2/28 |
| PharyngitisInfections and infestations | 2/27 | 0/25 | 2/28 |
| Age, Continuous(months) | Tiotropium Bromide & Salbutamol | Fluticasone Propionate & Salbutamol | Salbutamol | Total |
|---|---|---|---|---|
| Mean | 21.4 ± 7.0 | 20.0 ± 6.8 | 22.1 ± 6.0 | 21.2 ± 6.6 |
| Sex: Female, Male(Participants) | Tiotropium Bromide & Salbutamol | Fluticasone Propionate & Salbutamol | Salbutamol | Total |
|---|---|---|---|---|
| Female | 9 | 9 | 10 | 28 |
| Male | 18 | 16 | 18 | 52 |
| Race and Ethnicity Not Collected(Participants) | Tiotropium Bromide & Salbutamol | Fluticasone Propionate & Salbutamol | Salbutamol | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(Participants) | Tiotropium Bromide & Salbutamol | Fluticasone Propionate & Salbutamol | Salbutamol | Total |
|---|---|---|---|---|
| Finland | 27 | 25 | 28 | 80 |
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Helsinki University Central Hospital