The Bronchodilator Effect of Ultrafine Particles of Salbutamol
ISRCTN | ISRCTN89168782 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN89168782 |
Secondary identifying numbers | N0265126517 |
- 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
Scientific
Respiratory Medicine
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Phone | +44 (0)121 627 1627 |
---|---|
abc@email.com |
Study information
Study design | Double-blind random-order placebo-controlled accumulative dose-response study |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Salbutamol |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 05/09/2003 |
Completion date | 05/09/2004 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 8 adult volunteers |
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
- England
- United Kingdom
Study participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
B29 6JD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.dh.gov.uk/Home/fs/en |
---|
Funders
Funder type
Hospital/treatment centre
University Hospital Birmingham NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
31/03/2020: No publications found, all search options exhausted, study status unverified.