Condition category
Respiratory
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
14/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Henry Chrystyn

ORCID ID

Contact details

School of Pharmacy
University of Bradford
Bradford
BD7 1DP
United Kingdom
+44 (0)1274 233495
h.chrystyn@bradford.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0626168608

Study information

Scientific title

Acronym

Study hypothesis

Does an inhalation training aid designed for those using a Metered Dose Inhaler (MDI) maintain the correct inhalation technique after a patient has received training/counselling?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Respiratory: Asthma

Intervention

Patients will have their inhalation technique assessed whilst inhaling from a placebo inhaler. Those with a good technique will be placed in the control group. Those with a poor technique will form the intervention group. Subjects in the intervention group will be randomised into a group that receives verbal counselling on how to use their MDI and a group that also receives the verbal counselling with the addition of the Two Tone Training Aid.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Changes in inspiratory flow rates through MDIs.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2005

Overall trial end date

01/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Asthma
2. Patients using at least one MDI without a spacer device
Prescribed a preventer inhaler
3. Age 3-65 - Group 1: 3-6 years, Group 2: 7-17 years, Group 3: 16 to 65 years
4. Written signed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

120 patients will be recruited aged <17 and 17-65 years (40 participants in each of the three groups).

Participant exclusion criteria

1. Patients experiencing an acute exacerbation of asthma or receiving oral prednisolone in the four weeks prior to recruitment
2. Patients with other illnesses adversely affecting the respiratory system or evidence of fixed respiratory obstruction
3. Deaf or unable to distinguish between one and two tones with the Two-Tone trainer
4. Chronic obstructive pulmonary disease (COPD)

Recruitment start date

01/03/2005

Recruitment end date

01/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Pharmacy
Bradford
BD7 1DP
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Bradford South and West Primary Care Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17400675

Publication citations

  1. Results

    Al-Showair RA, Pearson SB, Chrystyn H, The potential of a 2Tone Trainer to help patients use their metered-dose inhalers., Chest, 2007, 131, 6, 1776-1782, doi: 10.1378/chest.06-2765.

Additional files

Editorial Notes