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
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