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Comparing the Efficacy of Two Valved Holding Chambers in Acute Wheezing (CHAMBER)

Primary Purpose

Bronchitis Obstructive, Bronchiolitis; Obstruction, Bronchospasm; Bronchitis

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
VHC 1
VHC 2
Sponsored by
Tampere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchitis Obstructive focused on measuring salbutamol, valved holding chamber, pMDI, inhalation therapy, children, toddlers, emergency room

Eligibility Criteria

6 Months - 4 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kuopio University HospitalRecruiting
  • Oulu University HospitalRecruiting
  • Terveystalo TampereRecruiting
  • Tampere University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Children treated with VHC 1

Children treated with VHC 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of subjects whose RDAI symptom score increase 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.
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 %.
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.

Secondary Outcome Measures

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.
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.
Readmission rate in both group
Re-hospitalization within 48 hours of initial treatment based on patient records.
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.
Difference in the mean heart rate change between groups
Change in heart rate per minute. Minimum N/A, maximum N/A.

Full Information

First Posted
March 29, 2019
Last Updated
April 17, 2019
Sponsor
Tampere University
Collaborators
Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital, Terveystalo Healthcare Services
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1. Study Identification

Unique Protocol Identification Number
NCT03900494
Brief Title
Comparing the Efficacy of Two Valved Holding Chambers in Acute Wheezing
Acronym
CHAMBER
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
Collaborators
Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital, Terveystalo Healthcare Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchitis Obstructive, Bronchiolitis; Obstruction, Bronchospasm; Bronchitis
Keywords
salbutamol, valved holding chamber, pMDI, inhalation therapy, children, toddlers, emergency room

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children treated with VHC 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Children treated with VHC 2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VHC 1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
VHC 2
Intervention Description
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 Outcome Measure Information:
Title
Number of subjects whose RDAI symptom score increase by 2 or more
Description
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.
Time Frame
20 minutes after the second salbutamol-dose and if necessary 20 minutes after the third or fourth salbutamol-dose. Maximum 5 hours.
Title
Difference in the mean capillary oxygen saturation change between groups
Description
Peripheral capillary oxygen saturation (%). Change from baseline at each evaluation point. Minimum 85 % (if below, not suitable for the study), maximum 100 %.
Time Frame
20 minutes after the second salbutamol-dose and if necessary 20 minutes after the third or fourth salbutamol-dose. Maximum 5 hours.
Title
Difference in the mean respiratory rate change between group
Description
Respiratory rate per minute. Change from baseline at each evaluation point. Minimum N/A, maximum N/A.
Time Frame
20 minutes after the second salbutamol-dose and if necessary 20 minutes after the third or fourth salbutamol-dose. Maximum 5 hours.
Secondary Outcome Measure Information:
Title
Compliance to treatment, compared between groups
Description
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.
Time Frame
Throughout the ER visit. Maximum 5 hours.
Title
Number of subjects hospitalized in both group
Description
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.
Time Frame
After the last dose of salbutamol. Maximum 5 hours.
Title
Readmission rate in both group
Description
Re-hospitalization within 48 hours of initial treatment based on patient records.
Time Frame
Within 48 hours of initial treatment.
Title
Number of drug doses given in both groups
Description
Number of salbutamol-doses given to the patient. Minimum two, maximum four doses. Less dose is better.
Time Frame
Throughout the ER visit. Maximum 5 hours.
Title
Difference in the mean heart rate change between groups
Description
Change in heart rate per minute. Minimum N/A, maximum N/A.
Time Frame
After each salbutamol dose. Maximum 5 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Csonka, MD. PhD.
Phone
+358503661103
Email
peter.csonka@tuni.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Palmu Sauli, MD. PhD.
Email
sauli.palmu@pshp.fi
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjo Renko, Professor
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terhi Tapiainen, MD, PhD
Facility Name
Terveystalo Tampere
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Csonka, MD, PhD
Phone
+358503661103
Email
peter.csonka@terveystalo.com
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sauli Palmu, MD. PhD.
Email
sauli.palmu@pshp.fi

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparing the Efficacy of Two Valved Holding Chambers in Acute Wheezing

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