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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 4
Healthy Volunteers: f
View:

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

Locations
Other Locations
Finland
Kuopio University Hospital
RECRUITING
Kuopio
Oulu University Hospital
SUSPENDED
Oulu
Tampere University Hospital
RECRUITING
Tampere
Terveystalo Tampere
RECRUITING
Tampere
Contact Information
Primary
Peter Csonka, MD. PhD.
peter.csonka@tuni.fi
+358503661103
Backup
Palmu Sauli, MD. PhD.
sauli.palmu@pshp.fi
Time Frame
Start Date: 2019-04-17
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 80
Treatments
Active_comparator: Children treated with VHC 1
In this group children are receiving salbutamol with valved holding chamber number 1. Otherwise the children in both groups are treated exactly the same way. The only difference is the device used to deliver the bronchodilator. Children in both arms have the same condition and the same inclusion and exclusion criteria. We only compare the efficacy of the two VHC devices.
Active_comparator: Children treated with VHC 2
In this group children are receiving salbutamol with valved holding chamber number 2. Otherwise the children in both groups are treated exactly the same way. The only difference is the device used to deliver the bronchodilator. Children in both arms have the same condition and the same inclusion and exclusion criteria. In this group children are receiving salbutamol with valved holding chamber number 1. Otherwise the children in both groups are treated exactly the same way. The only difference is the device used to deliver the bronchodilator. Children in both arms have the same condition and the same inclusion and exclusion criteria.
Related Therapeutic Areas
Sponsors
Collaborators: Oulu University Hospital, Tampere University Hospital, Terveystalo Healthcare Services, Kuopio University Hospital
Leads: Tampere University

This content was sourced from clinicaltrials.gov