Assessment of changes in ventilation following induced bronchoconstriction with inhaled histamine in normal subjects using Krypton-81m ventilation scintigraphy
| ISRCTN | ISRCTN70267623 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70267623 |
| Protocol serial number | N0016132052 |
| Sponsor | Department of Health |
| Funder | Hammersmith Hospital NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 13/02/2017
- 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 Philip Ind
Scientific
Scientific
Department of Respiratory Medicine
Clinical Investigation Unit
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
| Phone | +44 (0)208 383 2356 |
|---|---|
| p.ind@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Assessment of changes in ventilation following induced bronchoconstriction with inhaled histamine in normal subjects using Krypton-81m ventilation scintigraphy |
| Study objectives | The aim is to increase the understanding and develop quantitative measures of regional airway function using ventilation scanning using Krypton-81m. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory |
| Intervention | Single blind randomised controlled trial. The protocol compares histamine (to induce bronchoconstriction) with normal saline (as control) i.e. no bronchoconstriction. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Histamine |
| Primary outcome measure(s) | 1. To determine if ventilation scintigraphy can be used to determine and quantify regional changes in ventilation in the lung following histamine challenge in normal subjects 2. Also to determine the extent to which these correlate with changes in overall lung function |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 02/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Not Specified |
| Target sample size at registration | 8 |
| Key inclusion criteria | Volunteers - 8, ages 18-75 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 03/07/2002 |
| Date of final enrolment | 02/07/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hammersmith Hospital
London
W12 0HS
United Kingdom
W12 0HS
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/02/2017: No publications found, verifying study status with principal investigator.
