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
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