Clinical trial NCT03900494: Comparing the Efficacy of Two Valved Holding Chambers in Acute Wheezing
Official title: Comparing the Efficacy of Two Valved Holding Chambers for Bronchodilator Administration in 0.5-4 Years Old Children With Acute Wheezing - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchitis Obstructive
Bronchiolitis; Obstruction
Bronchospasm; Bronchitis
Keywords: salbutamol
valved holding chamber
pMDI
inhalation therapy
children
toddlers
emergency room
bronchitis
bronchiolitis
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Kuopio University Hospital
name: Oulu University Hospital
name: Tampere University Hospital
name: Terveystalo Healthcare Services
First posted: 2019-04-03
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence of physician confirmed asthma is approximately 4-7% in children. An additional 5% of children suffer from infection-related bronchiolitis and obstructive bronchitis. Of all patient visits at pediatric emergency rooms, 1 out of 10 is due to breathing difficulties with a great proportion leading to hospitalization.

Salbutamol is the most commonly used drug in the treatment in acute bronchial obstruction. A vast majority of children require a spacer device (valved holding chamber, VHC) for the delivery of the drug aerosol. There are several different types of VHC on the market, but no recommendations on the device selection have been published. Both in in vivo and in vitro studies significant differences between different spacer devices have been reported.

The study compares two different VHCs in the treatment of acute breathing difficulties in children. The end-points in this randomized physician-blinded study are symptom relief, rate of hospitalization, symptom recurrence, treatment compliance, and adverse events.

The study will be conducted in pediatric emergency rooms (ER) in three university hospitals in Finland and one private clinic that routinely treat this type of patients. The treatment is given according to national treatment guidelines and no blood samples are drawn for study purposes. Both of the VHCs used in this study have been approved for use in clinical practice.

Detailed description: This study compares two valved holding chamber (VHC) devices in the treatment of acute airway obstruction in children. Eighty children (6 months to 4 years of age) will be recruited with moderate to severe dyspnea according to the Respiratory Distress Assessment Instrument (RDAI score ≥6). After receiving an informed consent from the parents/caregivers, the child is randomized to receive treatment with either Babyhaler® or Optichamber Diamond® VHC. Patients with underlying medical conditions listed in the study protocol, patients requiring immediate hospitalization or not willing to participate will be excluded from the study. Information on the medical history together with treatment response will be recorded using a manual case report form. According to calculations of the statistical power using the RDAI-score as an end-point, a total of 80 patients (40 patients in both study groups) are needed for the study.

The study hypothesis is that the two VHCs are not equally efficient in treating acute shortage of breath in children aged 0.5-4 years.

Eligibility criteria: Inclusion Criteria:

- Children (age 0.5-4 years) seeking medical aid due to respiratory distress caused by bronchial obstruction

Exclusion Criteria:

* requiring immediate admission to inpatient treatment in hospital
* peripheral capillary oxygen saturation below 85% on admission
* physician-confirmed pneumonia
* inspiratory crackles on lung auscultation
* croup
* airway foreign body
* impaired renal or liver function
* immune compromised patient
* general condition affecting the study per investigation judgement
* bronchopulmonary dysplasia
* long-acting beta-adrenoceptor agonist treatment
* recruited to the ongoing study earlier
* have been enrolled in a clinical trial within 30 days prior to admission
* not willing to participate

Primary outcomes:
measure: Number of subjects whose RDAI symptom score increase by 2 or more
timeFrame: 20 minutes after the second salbutamol-dose and if necessary 20 minutes after the third or fourth salbutamol-dose. Maximum 5 hours.
measure: Difference in the mean capillary oxygen saturation change between groups
timeFrame: 20 minutes after the second salbutamol-dose and if necessary 20 minutes after the third or fourth salbutamol-dose. Maximum 5 hours.
measure: Difference in the mean respiratory rate change between group
timeFrame: 20 minutes after the second salbutamol-dose and if necessary 20 minutes after the third or fourth salbutamol-dose. Maximum 5 hours.
Secondary outcomes:
measure: Compliance to treatment, compared between groups
timeFrame: Throughout the ER visit. Maximum 5 hours.
measure: Number of subjects hospitalized in both group
timeFrame: After the last dose of salbutamol. Maximum 5 hours.
measure: Readmission rate in both group
timeFrame: Within 48 hours of initial treatment.
measure: Number of drug doses given in both groups
timeFrame: Throughout the ER visit. Maximum 5 hours.
measure: Difference in the mean heart rate change between groups
timeFrame: After each salbutamol dose. Maximum 5 hours.
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Terveystalo Tampere
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References: