Effect of obesity on asthma outcomes in acute exacerbation
| ISRCTN | ISRCTN66285433 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66285433 |
| Protocol serial number | N/A |
| Sponsor | West China Hospital at Sichuan University (China) |
| Funders | Doctoral Fund of Ministry of Education of China (China) (ref: 20070610155), National Natural Science Foundation of China (China) (ref: 30971326; 30901907) |
- 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
Scientific
Pneumology Group
Department of Integrated Traditional Chinese and Western Medicine
Sichuan University
Chengdu
610041
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre interventional single-arm cohort study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of obesity on asthma outcomes in acute exacerbation: a multicentre interventional cohort study |
| Study objectives | 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(s) | The Medical Ethics Committee of West China Hospital at Sichuan University approved on the 21st June 2010. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. The number of puffs of beta agonists (salbutamol) recorded in asthma diary by the patient himself every day during 7-day study |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 2000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/07/2010 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- China
Study participating centre
Pneumology Group
Chengdu
610041
China
610041
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
