NCT04262271

Brief Summary

This study will observe the inhaler technique of people using 13 different inhaler types; record any technique errors being made against checklists developed for each inhaler device based on their manufacturer's guidelines, and reeducate any observed inhaler technique errors as required.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
734

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 7, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

2.9 years

First QC Date

February 7, 2020

Last Update Submit

April 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • To assess the prevalence of device-specific inhaler technique errors (ITE), in 13 different devices using manufacturers' guidelines.

    Device Specific inhaler technique errors

    one study visit- day 1

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any person over the age of 16 who uses and inhaler device for an airways condition.

You may qualify if:

  • Aged ≥16 years
  • Have been prescribed (by a doctor or healthcare professional) 1 of 13\* inhaler device types for an airways condition.
  • \*Accuhaler, Autohaler, Breezhaler, Easi-breathe, Easyhaler, Ellipta, Genuair, Handihaler, Nexthaler, pMDI, pMDI plus spacer (e.g. Aerochamber or Volumatic), Respimat and Turbohaler
  • Able to provide written informed consent

You may not qualify if:

  • Currently on treatment with systemic steroids and/or antibiotics for an exacerbation of the participants' airways condition.
  • In the opinion of the investigator that the participant will be unable to perform the study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmouth Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Location

Related Publications (1)

  • De Vos R, Brown T, Longstaff J, Lomax M, Mackenzie H, Hicks A, Rupani H, Gates J, Fox L, Wiffen L, Chauhan AJ. A Study to Investigate the Prevalence of Device-Specific Errors in Inhaler Technique in Adults With Airway Disease (The SCORES Study): Protocol for a Single Visit Prevalence Study. JMIR Res Protoc. 2021 Aug 27;10(8):e26350. doi: 10.2196/26350.

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 10, 2020

Study Start

August 7, 2019

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

April 10, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations