Bronchitis ObstructiveCHAMBERNCT03900494
Comparing the Efficacy of Two Valved Holding Chambers in Acute Wheezing
A study testing VHC 1 and VHC 2 in people with Bronchitis Obstructive and Bronchiolitis; Obstruction, run by Tampere University at 4 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- Bronchitis Obstructive, Bronchiolitis; Obstruction, Bronchospasm; Bronchitis
- What is being tested?
- VHC 1 and VHC 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesFinland
- Study dates
- 17 Apr 2019to 23 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (age 0.5-4 years) seeking medical aid due to respiratory distress caused by bronchial obstruction
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Kuopio University Hospital
Kuopio, 70210
Oulu University Hospital
Oulu, 90220
Terveystalo Tampere
Tampere, 33100
Tampere University Hospital
Tampere, 33521
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- VHC 1, VHC 2
- Keywords
- salbutamol, valved holding chamber, pMDI, inhalation therapy, children, toddlers, emergency room, bronchitis, bronchiolitis
- Medical subject headings
- Bronchiolitis, Bites and Stings, Bronchial Spasm, Bronchitis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VHC 1Device
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 2Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: VHC 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 %.
Measured: 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.
Measured: 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
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.
Measured: Throughout the ER visit. Maximum 5 hours.
Number of subjects hospitalized in both group
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.
Measured: After the last dose of salbutamol. Maximum 5 hours.
Number of drug doses given in both groups
Number of salbutamol-doses given to the patient. Minimum two, maximum four doses. Less dose is better.
Measured: Throughout the ER visit. Maximum 5 hours.
Difference in the mean heart rate change between groups
Change in heart rate per minute. Minimum N/A, maximum N/A.
Measured: After each salbutamol dose. Maximum 5 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start17 Apr 2019
- Primary completion23 May 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchitis ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital, Terveystalo Healthcare Services
- Responsible party
- Principal investigator, Peter Csonka, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900494
- Sponsor's protocol ID
- ETL-R19030
- Acronym
- CHAMBER
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2019
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 May 1;180(5):567-574. doi: 10.1001/jamapediatrics.2025.6479.
PubMed 41729513
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03900494
- Acronym / sponsor ID
- CHAMBER / ETL-R19030
- Keywords
- salbutamol, valved holding chamber, pMDI, inhalation therapy, children, toddlers, emergency room, bronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital, Terveystalo Healthcare Services
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children treated with VHC 1 | Active comparator | Device: VHC 1In 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. |
| Children treated with VHC 2 | Active comparator | Device: VHC 2In 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. |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children (age 0.5-4 years) seeking medical aid due to respiratory distress caused by bronchial obstruction
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VHC 1Salbutamol 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. | Device | Children treated with VHC 1 |
| VHC 2Salbutamol 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. | Device | Children treated with VHC 2 |
Primary outcome
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.
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 %.
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.
4 secondary outcomes
Compliance to treatment, compared between groups
Time frame: Throughout the ER visit. Maximum 5 hours.
Number of subjects hospitalized in both group
Time frame: After the last dose of salbutamol. Maximum 5 hours.
Number of drug doses given in both groups
Time frame: Throughout the ER visit. Maximum 5 hours.
Difference in the mean heart rate change between groups
Time frame: After each salbutamol dose. Maximum 5 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Derived from this study: PubMed 41729513Csonka 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 May 1;180(5):567-574. doi: 10.1001/jamapediatrics.2025.6479.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VHC 1 and VHC 2 in people with Bronchitis Obstructive and Bronchiolitis; Obstruction, run by Tampere University at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03900494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.