Effect of obesity on asthma outcomes in acute exacerbation

ISRCTN ISRCTN66285433
DOI https://doi.org/10.1186/ISRCTN66285433
Secondary identifying numbers N/A
Submission date
17/07/2010
Registration date
12/08/2010
Last edited
12/08/2010
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

Prof Gang Wang
Scientific

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

Study information

Study designMulticentre interventional single-arm cohort study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffect of obesity on asthma outcomes in acute exacerbation: a multicentre interventional cohort study
Study objectivesThe 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(s)The Medical Ethics Committee of West China Hospital at Sichuan University approved on the 21st June 2010.
Health condition(s) or problem(s) studiedMild to moderate asthma in acute exacerbation
InterventionAccording 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 typeOther
Primary outcome measureThe 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 measures1. 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 study start date30/07/2010
Completion date30/06/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants2000
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment30/07/2010
Date of final enrolment30/06/2011

Locations

Countries of recruitment

  • China

Study participating centre

Pneumology Group
Chengdu
610041
China

Sponsor information

West China Hospital at Sichuan University (China)
Hospital/treatment centre

Guoxue street No. 37
Chengdu
610041
China

Website http://eng.cd120.com/
ROR logo "ROR" https://ror.org/007mrxy13

Funders

Funder type

Government

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

No information available

National Natural Science Foundation of China (China) (ref: 30971326; 30901907)
Government organisation / National government
Alternative name(s)
Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
Location
China

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan