Condition category
Respiratory
Date applied
12/09/2005
Date assigned
02/12/2005
Last edited
21/03/2012
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 John Wilding

ORCID ID

Contact details

Clinical Sciences Centre
University Hospital Aintree
Liverpool
L9 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04/048

Study information

Scientific title

Acronym

Study hypothesis

Epidemiological studies suggest higher prevalence in obese subjects. Weight loss improves many features of asthma. Whilst lung function will improve with weight loss as a result of mechanical work, it is difficult to explain improvements in bronchial hyper-reactivity and airway inflammation purely on a mechanical basis. Obesity is associated with a state of immune activation that could amplify the process of autoimmunity.

We hypothesize that immunological mechanisms partly account for the relationship between obesity and asthma. More specifically, we propose that increased concentrations of the adipokines leptin and tumour necrosis factor alpha and reduced concentrations of adiponectin in obese subjects are promoters of inflammation in asthma, and that improvements in asthma with weight loss are related to changes in the systemic and local (within the bronchial tree) concentrations of these factors as well as a reduction in mechanical work.

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

Treatment

Patient information sheet

Condition

Asthma and obesity

Intervention

Dietary intervention: Meal replacement therapy for six months plus dietition advice and support for intervention group versus healthy eating leaflet for control group

Exhaled nitric oxide measurements.
Methacholine challenge testing - tidal breathing method.
Airway resistance with plethysmography.
Induced sputum plus sputum cell counts and supernatent inflammatory markers.
Blood inflammatory markers.
Height, weight and bioimpedence.
SGRQ, SF36, IQWOL-LITE questionnaires.
Peak flow and symptom diary monitoring.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Expected weight loss in the intensive group of 10 to 12 kg (10 - 20% body weight), compared to minimal weight loss in the conventional group. This should result in significant improvements in pulmonary function i.e. reduced bronchoconstriction, reduced peak flow variability and reduced bronchial hyper-reactivity.

Secondary outcome measures

1. Reduction in systemic inflammation in the intensively treated group
2. Reduction in markers of local airway inflammation in the intensively treated group
3. Improvement in health status of intensively treated group

Overall trial start date

01/01/2005

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Obesity (body mass index more than 30 kg/m^2
2. Age 18 to 65 years
3. Asthma requiring treatment with at least a long-acting inhaled corticosteroid and an inhaled beta agonist

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Subjects on long-term oral corticosteroids
2. Diabetes mellitus
3. Pregnancy or breastfeeding
4. History of major eating disorder
5. History of food allergy to any component of Slimfast
6. Major psychiatric disease
7. Current smokers
8. Uncontrolled thyroid disease
9. History of severe cardiac, hepatic or renal disease, malignancy, or any other condition that might, in the opinion of the investigators preclude completion of the study

Recruitment start date

01/01/2005

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Sciences Centre
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

Liverpool
L69 3BX
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Asthma UK (Project ID 04/048).

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21868466

Publication citations

  1. Results

    Scott S, Currie J, Albert P, Calverley P, Wilding JP, Risk of misdiagnosis, health-related quality of life, and BMI in patients who are overweight with doctor-diagnosed asthma., Chest, 2012, 141, 3, 616-624, doi: 10.1378/chest.11-0948.

Additional files

Editorial Notes