Condition category
Respiratory
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
08/04/2014
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 Philip Ind

ORCID ID

Contact details

Department of Respiratory Medicine
Clinical Investigation Unit
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
+44 (0)208 383 2356
p.ind@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0016132052

Study information

Scientific title

Acronym

Study hypothesis

Aim is to increase the understanding and develop quantitative measures of regional airway function using ventilation scanning using Krypton-81m.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Respiratory

Intervention

Single blind randomised controlled trial. The protocol compares histamine (to induce bronchoconstriction) with normal saline (as control) ie no bronchoconstriction.

Intervention type

Drug

Phase

Not Specified

Drug names

histamine

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

03/07/2002

Overall trial end date

02/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Volunteers - 8, ages 18-75.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

8

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

03/07/2002

Recruitment end date

02/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Respiratory Medicine
London
W12 0HS
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

Government

Funder name

Hammersmith Hospital 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