Condition category
Respiratory
Date applied
17/07/2010
Date assigned
12/08/2010
Last edited
12/08/2010
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

Prof Gang Wang

ORCID ID

Contact details

Pneumology Group
Department of Integrated Traditional Chinese and Western Medicine
Sichuan University
Chengdu
610041
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of obesity on asthma outcomes in acute exacerbation: a multicentre interventional cohort study

Acronym

Study hypothesis

The prevalence of both obesity and asthma is increasing throughout the Western world and increased body mass index (BMI) may be a risk factor for the development of asthma. Recent studies have indicated that obese subjects with asthma report greater resistance to therapy and poorer asthma control than normal-weight subjects with asthma. However effect of obesity on asthma outcomes in acute exacerbation remains unclear.

Ethics approval

The Medical Ethics Committee of West China Hospital at Sichuan University approved on the 21st June 2010.

Study design

Multicentre interventional single-arm cohort study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mild to moderate asthma in acute exacerbation

Intervention

According to Chinese cut-off criteria of obesity, the subjects with asthma are divided into four groups which are the underweight group with BMI less than 18.5 kg/m2, the normal group with BMI between 18.5 and 23.9 kg/m2, the overweight group with BMI between 24.0 and 27.9 kg/m2, and the obese group with BMI greater than 28.0 kg/m2.

Interventions for all groups: beta-2-agonists (salbutamol), systemic steroids (0.5 - 1 mg/kg) if necessary.

Period of treatment: 7 days, no follow-up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The number of patients with use of systemic steroids and steroid dose, and the number of patients with hospital admission, which are evaluated at days 4 and 8.

Secondary outcome measures

1. The number of puffs of beta agonists (salbutamol) recorded in asthma diary by the patient himself every day during 7-day study
2. Lung functions (PEF), which are assessed at hours 0, 2, 4, 6, 8, 10, 12 after recruitment, and in morning and evening every day during 7-day of treatment

Overall trial start date

30/07/2010

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Mild to moderate asthma in acute exacerbation
2. Male and female patients between 15 and 75 years
3. Within 72 hours of onset of acute asthma
4. Ability to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant exclusion criteria

1. Use of systemic steroids or immunosuppressive agents within one month before recruitment, or history of life-threatening asthma requiring treatment with intubation and mechanical ventilation
2. Maintenance therapy with symbicort, or rescue therapy with formoterol or anticholinergic agents
3. Current alcoholism or drug abuse
4. Lung diseases other asthma
5. Severe diseases of cardiovascular, hepatic, renal, central nervous system, haematopoietic system cancer
6. Significant medical illness (other than asthma) that is not stable
7. History of respiratory tract infection within the previous 6 weeks
8. Pregnancy or breast-feeding
9. The inability to understand and complete this study
10. Peptic ulcer or gastrointestinal haemorrhage
11. Intolerance to beta-2-agonists or steroids

Recruitment start date

30/07/2010

Recruitment end date

30/06/2011

Locations

Countries of recruitment

China

Trial participating centre

Pneumology Group
Chengdu
610041
China

Sponsor information

Organisation

West China Hospital at Sichuan University (China)

Sponsor details

Guoxue street No. 37
Chengdu
610041
China

Sponsor type

Hospital/treatment centre

Website

http://eng.cd120.com/

Funders

Funder type

Government

Funder name

Doctoral Fund of Ministry of Education of China (China) (ref: 20070610155)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Natural Science Foundation of China (China) (ref: 30971326; 30901907)

Alternative name(s)

National Science Foundation of China, Natural Science Foundation of China, NSFC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

China

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