NCT04182009

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 2, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

June 12, 2019

Last Update Submit

November 26, 2019

Conditions

AsthmaCOPD

Keywords

AsthmaCOPDNebuliserSputum InductionSafetyTolerabilityQualityQuantityPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • The tolerability to sputum induction test

    Checking discomfort degree due to inhalation of hypertonic saline assessed by a visual analogue scale (0 to 10)

    During the visit, after each cycle of nebulisation (each 5 minutes)

Secondary Outcomes (7)

  • Spirometry

    During the visit, up to 4 hours

  • Borg Scale

    During the visit, up to 4 hours

  • The quality of sputum samples

    During the processing time, 2 hours

  • The quantity of sputum samples

    During the visit, up to 4 hours

  • Time to produce sample

    During the visit, up to 30 minutes

  • +2 more secondary outcomes

Study Arms (2)

Omron

OTHER

Omron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2.

Device: Omron NE-U17 Ultrasonic nebuliserDevice: Akita Jet Inhalation System

Akita

ACTIVE COMPARATOR

Akita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2.

Device: Omron NE-U17 Ultrasonic nebuliserDevice: Akita Jet Inhalation System

Interventions

Omron NE-U17 Ultrasonic nebuliserDEVICE

The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.

AkitaOmron
Akita Jet Inhalation SystemDEVICE

The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.

AkitaOmron

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have an ability to provide fully informed consent.
  • Have a diagnosis of asthma or COPD.
  • Male or female.
  • Age between 18 to 75 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham Respiratory Research Unit

Nottingham, NG5 1PB, United Kingdom

RECRUITING

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Professor Tim W Harrison, MBBS, BSc, MD, MSc

    Professor and Honorary Consultant, University of Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Paula Almeida, PT, DHSc

CONTACT

0115 9691169paula.almeida@nottingham.ac.uk

Katherine M Smith, BA(Hons), MA

CONTACT

0115 8231911katherine.m.smith@nottingham.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2019

First Posted

December 2, 2019

Study Start

September 17, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

December 2, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)