Condition category
Respiratory
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
11/12/2014
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

Dr W S Tunnicliffe

ORCID ID

Contact details

Respiratory Medicine
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
+44 (0)121 627 1627
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265126517

Study information

Scientific title

The Bronchodilator Effect of Ultrafine Particles of Salbutamol

Acronym

Study hypothesis

Do ultrafine particles of inhaled salbutamol generated from a standard nebulised dose (2.5 mg) cause measurable bronchodilation in patients with asthma?

Ethics approval

Not provided at time of registration

Study design

Double-blind random-order placebo-controlled accumulative dose-response study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Respiratory: Asthma

Intervention

This is a double blind, random-order, placebo-controlled accumulative dose-response study exploring the bronchodilator effects of ultrafine particles of salbutamol in a group of subjects with asthma. The placebo limb will use ultrafine particles of 0.9% saline, generated in an identical way to the active (salbutamol) aerosol.

Intervention type

Drug

Phase

Not Specified

Drug names

Salbutamol

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

05/09/2003

Overall trial end date

05/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years
2. The presence of mild to moderate asthma
3. Willingness and ability to give written informed consent

Potential volunteers will be identified from two sources; prospectively from patients attending Dr D Thickett's respiratory out-patient clinics at UHB trust, and from poster advertisements displayed in the staff common rooms of the Trusts critical care units. In each case, interested parties will be invited to contact the principal investigator by phone to discuss possible participation further. If they would still like to consider participation they will be sent a volunteer information sheet, a copy of the consent form and a 'reply paid' slip by mail. On receipt of the reply slip, the principal investigator will contact them again by phone to arrange a mutually convenient date for them to attend for the first study day. Formal informed written consent will be obtained when participants attend for the first study day. At no time will the participants be pressurised into taking part in any way. No inducements will be offered, but traveling expenses will be refunded if requested.
Participants will be asked if they would like their general practitioners to be informed of their participation in the study. If so, a letter explaining the study and detailing the individual's participation will be sent by first class post to the general practitioner on the first study day.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8 adult volunteers

Participant exclusion criteria

1. The use of > 1000 mcg Beclomethasone (or equivalent) per day
2. Unstable asthma
3. Inability or unwillingness to discontinue long acting and oral bronchodilators for 24 hours, and all short acting bronchodilators for 4 hours prior to each study.

Recruitment start date

05/09/2003

Recruitment end date

05/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Birmingham NHS 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

Publication citations

Additional files

Editorial Notes