Back to resultsA Comparison of Two Nebulisers for Sputum Induction (FLAME)
Primary Purpose
Asthma, COPD
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Omron NE-U17 Ultrasonic nebuliser
Akita Jet Inhalation System
Sponsored by
About this trial
This is an interventional other trial for Asthma focused on measuring Asthma, COPD, Nebuliser, Sputum Induction, Safety, Tolerability, Quality, Quantity, Physiotherapy
Eligibility Criteria
Inclusion Criteria:
- Have an ability to provide fully informed consent.
- Have a diagnosis of asthma or COPD.
- Male or female.
- Age between 18 to 75 years.
Exclusion Criteria:
- Have a post bronchodilator Forced Expiratory Volume in the first second of less than 1 litre or less than 50 percent of the predicted value.
- Have an exacerbation of asthma or COPD within the 30 days prior to the first visit.
- Have a history or current evidence of an upper or lower respiratory infection, within the 30 days prior to the first visit.
- Have any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the investigators to impact on the ability to participate in the study.
Sites / Locations
- Nottingham Respiratory Research UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Omron
Akita
Arm Description
Omron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2.
Akita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2.
Outcomes
Primary Outcome Measures
The tolerability to sputum induction test
Checking discomfort degree due to inhalation of hypertonic saline assessed by a visual analogue scale (0 to 10)
Secondary Outcome Measures
Spirometry
Measurement of lung function (FEV1 and FEV1%pred)
Borg Scale
Measurement of dyspnoea levels
The quality of sputum samples
The analysis of squamous contamination in the sample (if >40%), viability (>65% of life cells) and quality of slide for differential cells count
The quantity of sputum samples
How much sputum sample was produced of sufficient quality for processing
Time to produce sample
The time in minutes required to produce a sputum sample sufficient for processing
Saline quantity
The amount of sterile saline required to produce a sputum sample sufficient for processing
Influence of Physiotherapy techniques
The influence of manual vibrations and Huff cough in producing a sputum sample after unsuccessful induction attempts
Full Information
NCT ID
NCT04182009
First Posted
June 12, 2019
Last Updated
November 26, 2019
Sponsor
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT04182009
Brief Title
A Comparison of Two Nebulisers for Sputum Induction
Acronym
FLAME
Official Title
A Comparison of Two Nebulisers for Performing Sputum Induction to Assess Airway Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sputum induction is considered a relatively non-invasive, reliable procedure, which can be utilised to characterise the inflammatory profile of the airways.
However, the procedure can be slightly uncomfortable for patients. This study aims to assess the differences in participants' tolerability of sputum induction, by comparing two different nebulisers when performing the procedure.
Detailed Description
This is a single centre, crossover study to compare the use of two nebulisers in the sputum induction procedure. 54 participants with stable asthma or COPD will be recruited and will attend 2 visits, at least 48 hours apart. Differences in the quality and quantity of samples and the time taken to produce a sample will be described. The main purpose is to explore the optimum device to perform the procedure, whilst protecting the safety of participants and maximising their comfort.
If participants are unable to produce a sputum sample after completion of the induction procedure, physiotherapy techniques may be performed. This is an exploratory objective to establish whether these techniques may help in the event of unsuccessful procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, COPD
Keywords
Asthma, COPD, Nebuliser, Sputum Induction, Safety, Tolerability, Quality, Quantity, Physiotherapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Omron
Arm Type
Other
Arm Description
Omron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2.
Arm Title
Akita
Arm Type
Active Comparator
Arm Description
Akita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2.
Intervention Type
Device
Intervention Name(s)
Omron NE-U17 Ultrasonic nebuliser
Intervention Description
The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.
Intervention Type
Device
Intervention Name(s)
Akita Jet Inhalation System
Intervention Description
The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.
Primary Outcome Measure Information:
Title
The tolerability to sputum induction test
Description
Checking discomfort degree due to inhalation of hypertonic saline assessed by a visual analogue scale (0 to 10)
Time Frame
During the visit, after each cycle of nebulisation (each 5 minutes)
Secondary Outcome Measure Information:
Title
Spirometry
Description
Measurement of lung function (FEV1 and FEV1%pred)
Time Frame
During the visit, up to 4 hours
Title
Borg Scale
Description
Measurement of dyspnoea levels
Time Frame
During the visit, up to 4 hours
Title
The quality of sputum samples
Description
The analysis of squamous contamination in the sample (if >40%), viability (>65% of life cells) and quality of slide for differential cells count
Time Frame
During the processing time, 2 hours
Title
The quantity of sputum samples
Description
How much sputum sample was produced of sufficient quality for processing
Time Frame
During the visit, up to 4 hours
Title
Time to produce sample
Description
The time in minutes required to produce a sputum sample sufficient for processing
Time Frame
During the visit, up to 30 minutes
Title
Saline quantity
Description
The amount of sterile saline required to produce a sputum sample sufficient for processing
Time Frame
During the visit, up to 30 minutes
Title
Influence of Physiotherapy techniques
Description
The influence of manual vibrations and Huff cough in producing a sputum sample after unsuccessful induction attempts
Time Frame
During the study visit, up to 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have an ability to provide fully informed consent.
Have a diagnosis of asthma or COPD.
Male or female.
Age between 18 to 75 years.
Exclusion Criteria:
Have a post bronchodilator Forced Expiratory Volume in the first second of less than 1 litre or less than 50 percent of the predicted value.
Have an exacerbation of asthma or COPD within the 30 days prior to the first visit.
Have a history or current evidence of an upper or lower respiratory infection, within the 30 days prior to the first visit.
Have any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the investigators to impact on the ability to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Paula Almeida, PT, DHSc
Phone
0115 9691169
Ext
58012
Email
paula.almeida@nottingham.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine M Smith, BA(Hons), MA
Phone
0115 8231911
Email
katherine.m.smith@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Tim W Harrison, MBBS, BSc, MD, MSc
Organizational Affiliation
Professor and Honorary Consultant, University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham Respiratory Research Unit
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Paula Almeida, PT, DHSc
Phone
0115 9691169
Ext
58012
Email
paula.almeida@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
Katherine M Smith, BA(Hons), MA
Phone
0115 8231911
Email
katherine.m.smith@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
Professor Tim W Harrison, MBBS, MD,
12. IPD Sharing Statement
Plan to Share IPD
No
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A Comparison of Two Nebulisers for Sputum Induction
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