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NCT Number: NCT03900494

Comparing the Efficacy of Two Valved Holding Chambers in Acute Wheezing

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.

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Key information

Conditions

Bronchitis Obstructive Bites and Stings Bronchial Diseases Bronchial Spasm Bronchiolitis Bronchiolitis; Obstruction Bronchitis Bronchospasm; Bronchitis Chemically-Induced Disorders Disease Attributes Emergencies Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Poisoning Respiratory Tract Diseases Respiratory Tract Infections Wounds and Injuries

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital, Kuopio, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

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

    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.

  2. Difference in the mean capillary oxygen saturation change between groups

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

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

  3. Difference in the mean respiratory rate change between group

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

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

Secondary outcomes

  1. Compliance to treatment, compared between groups

    Time frame: Throughout the ER visit. Maximum 5 hours.

    Compliance to the treatment using a structured questionnaire conducted both by the parents and by the nurses treating the child in the emergency room.

    Cooperation score from 0 to 5: 0 = no measurement possible; 1 = continuously crying, screaming, or struggling against the procedure; 2 = crying, screaming, or struggling, but not continuously; 3 = not very good cooperation, but no crying or screaming; 4 = good cooperation, but clearly not comfortable; 5 = good cooperation and quiet breathing during the whole measurement.

  2. Number of subjects hospitalized in both group

    Time frame: After the last dose of salbutamol. Maximum 5 hours.

    The information on whether the patient is discharged from the emergency room or admitted to hospital for further treatment will be recorded in the case report form.

  3. Number of drug doses given in both groups

    Time frame: Throughout the ER visit. Maximum 5 hours.

    Number of salbutamol-doses given to the patient. Minimum two, maximum four doses. Less dose is better.

  4. Difference in the mean heart rate change between groups

    Time frame: After each salbutamol dose. Maximum 5 hours.

    Change in heart rate per minute. Minimum N/A, maximum N/A.

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

  • Kuopio University Hospital
  • Oulu University Hospital
  • Tampere University Hospital
  • Terveystalo Healthcare Services

Registry information

Official study 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

Acronym: CHAMBER

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2019
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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