The Bronchodilator Effect of Ultrafine Particles of Salbutamol

ISRCTN	ISRCTN89168782
DOI	https://doi.org/10.1186/ISRCTN89168782
Protocol serial number	N0265126517
Sponsor	Department of Health
Funder	University Hospital Birmingham NHS Trust (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 31/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr W S Tunnicliffe
Scientific

Respiratory Medicine
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Phone	+44 (0)121 627 1627
Email	abc@email.com

Study information

Primary study design	Interventional
Study design	Double-blind random-order placebo-controlled accumulative dose-response study
Secondary study design	Randomised controlled trial
Scientific title	The Bronchodilator Effect of Ultrafine Particles of Salbutamol
Study objectives	Do ultrafine particles of inhaled salbutamol generated from a standard nebulised dose (2.5 mg) cause measurable bronchodilation in patients with asthma?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Salbutamol
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	05/09/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	8
Key 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.
Key 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.
Date of first enrolment	05/09/2003
Date of final enrolment	05/09/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Selly Oak Hospital

Birmingham
B29 6JD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

31/03/2020: No publications found, all search options exhausted, study status unverified.