Comparing the Efficacy of Two Valved Holding Chambers in Acute Wheezing

NCT03900494 | Completed

• 1 other identifier: ETL-R19030
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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.

Conditions

Bronchitis Obstructive; Bronchiolitis; Obstruction; Bronchospasm; Bronchitis

Keywords

salbutamol; valved holding chamber; pMDI; inhalation therapy; children; toddlers; emergency room; bronchitis; bronchiolitis

Outcome Measures

Primary Outcomes (3)

• Number of subjects whose RDAI symptom score decrased by 2 or more

  Respiratory Distress Assessment Instrument (RDAI) score. Change from baseline at each evaluation point. Discharge time is dependent on the score at each evaluation point. Minimum score 0 (best), maximum score 17 (worst). Inclusion criteria is at least 6.

  20 minutes after the second salbutamol-dose and if necessary 20 minutes after the third or fourth salbutamol-dose. Maximum 5 hours.

• Difference in the mean capillary oxygen saturation change between groups

  Peripheral capillary oxygen saturation (%). Change from baseline at each evaluation point. Minimum 85 % (if below, not suitable for the study), maximum 100 %.

  20 minutes after the second salbutamol-dose and if necessary 20 minutes after the third or fourth salbutamol-dose. Maximum 5 hours.

• Difference in the mean respiratory rate change between group

  Respiratory rate per minute. Change from baseline at each evaluation point. Minimum N/A, maximum N/A.

  20 minutes after the second salbutamol-dose and if necessary 20 minutes after the third or fourth salbutamol-dose. Maximum 5 hours.

Secondary Outcomes (4)

• Compliance to treatment, compared between groups

  Throughout the ER visit. Maximum 5 hours.

• Number of subjects hospitalized in both group

  After the last dose of salbutamol. Maximum 5 hours.

• Number of drug doses given in both groups

  Throughout the ER visit. Maximum 5 hours.

• Difference in the mean heart rate change between groups

  After each salbutamol dose. Maximum 5 hours.

Study Arms (2)

Children treated with VHC 1

ACTIVE COMPARATOR

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.

Device: VHC 1

Children treated with VHC 2

ACTIVE COMPARATOR

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.

Device: VHC 2

Interventions

VHC 1 DEVICE

Salbutamol 0.6-0.8 mg given 20-40 min. maximum four times depending on the bronchodilator response delivered via valved holding chamber 1. Same salbutamol dosing protocol for both arms. Only difference is the VHC used.

Children treated with VHC 1

VHC 2 DEVICE

Salbutamol 0.6-0.8 mg given 20-40 min. maximum four times depending on the bronchodilator response delivered via valved holding chamber 2. Same salbutamol dosing protocol for both arms. Only difference is the VHC used.

Children treated with VHC 2

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University: lead
• Kuopio University Hospital: collaborator
• Oulu University Hospital: collaborator
• Tampere University Hospital: collaborator
• Terveystalo Healthcare Services: collaborator

Study Sites (4)

Kuopio University Hospital

Kuopio, 70210, Finland

Location

Oulu University Hospital

Oulu, 90220, Finland

Location

Terveystalo Tampere

Tampere, 33100, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Related Publications (1)

• Csonka P, Ruuska-Loewald T, Hamynen I, Honkila M, Ojaniemi I, Mykkanen E, Kelemen B, Juntunen M, Kuusela S, Renko M, Lehtimaki L, Pokka T, Palmu S. Valved Holding Chambers in Young Children With Acute Wheezing: A Randomized Clinical Trial. JAMA Pediatr. 2026 Feb 23:e256479. doi: 10.1001/jamapediatrics.2025.6479. Online ahead of print.

  PMID: 41729513 DERIVED

MeSH Terms

Conditions

Bronchiolitis; Bites and Stings; Bronchial Spasm; Bronchitis; Emergencies

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in pediatrics and pediatric allergology

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 3, 2019
• Study Start: April 17, 2019
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

FI (4)