A Appropriate Disease Management Scheme Research for the Asthma Patients in Basic Level Medical Institution

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IOR-14005493
• Date of registration: 2014-11-11
• Prospective Registration: Yes
• Primary sponsor: Respiratory Department, Xinqiao Hospital (2nd Affiliated Hospital) of Third Military University, Chongqing
• Public title: A Appropriate Disease Management Scheme Research for the Asthma Patients in Basic Level Medical Institution
• Scientific title: A Appropriate Disease Management Scheme Research for the Asthma Patients in Basic Level Medical Institution
• Date of first enrolment: 2014-11-15
• Target sample size: 1:40;2:40;3:40;4:50;5:50;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=9860
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Wang Changzheng

• Name: Wan Min
• Affiliation: Respiratory Department, Xinqiao Hospital(2nd Affiliated Hospital) of Third Military University, Chongqing

Key inclusion & exclusion criteria

Inclusion criteria: Sub Study 1:
1. 18-60 years old;
2. Without ICS treatment or asthma patients use low dose ICS (FP = 500ug/d) did not reach the control 4 weeks ago;
3. FEV1 accounted for the expected value 40-90%, within 3 months of diastolic test positive (inhalation of salbutamol 400 g FEV1 improvement rate was higher than 12%, and the increase is greater than or equal to 200ml) or bronchial provocation test positive;
4. the screening period within 7 days after the diurnal or nocturnal asthma symptoms (wheezing, shortness of breath, chest tightness or cough) over 3 days;
5. patients have the ability to fill in the diary card, AQLQ, ACT score, the proper use of peak flow meter and the study of drug;
6. agreed to participate in the study and signed the informed consent of patients.

Sub Study 2:
1. 18-60 years old;
2. consistent with the diagnosis of acute exacerbation of asthma, and the assessment of the severity of severe acute exacerbation of asthma patients belong to;
3. patients have the ability to fill in the diary card, AQLQ, ACT score, the proper use of peak flow meter and the study of drug;
4. agreed to participate in the study and signed the informed consent of patients.

Sub Study 3:
1. 18-60 years old;
2. consistent with the diagnosis of asthma;
3. patients have the ability to fill in the diary card, ACT score, the proper use of peak flow meter and asthma diary;
4. agreed to participate in the study and signed the informed consent of patients.
Exclusion criteria: Sub Study 1:
1. have serious heart and lung diseases, COPD, digestive ulcer history;
2. within screening 8 weeks, had respiratory tract infection;
3. within screening 6 weeks, used systemic glucocorticoid;
4. screening period cannot be disabled inhaled anticholinergic drugs, oral and inhaled long-acting beta 2 agon-ists as well as in the treatment period cannot be disabled leukotriene receptor antagonist and anti histamine drug therapy;
5. known or suspected of theophylline, ICS, beta 2 agonists allergy or contraindication;
6. pregnancy, planned pregnancy or lactating women;
7. current or former smokers, smoking history more than 10 pack years;
8. blood routine, urine routine, blood biochemical abnormalities; alanine aminotransferase / aspartate aminotransferase (ALT/AST) exceeds the upper limit of normal 2 times greater than 1.5 times the upper limit of normal serum bilirubin, serum creatinine greater than 1.2 times the upper limit of normal;
9. patients in the 1 months before the screening period in 6 half lives of other clinical research or the research study on the washout period is still in a drug, whichever is longer;
10. clear seasonal, occupational asthma or by explicitly induced factors caused can not be divorced from the inducing factors of patients.

Sub study 2:
1. have serious heart and lung diseases, COPD, digestive ulcer history;
2. within screening 6 weeks,used systemic glucocorticoid;
3. known or suspected allergy to theophylline and beta 2 agonists and accessories or contraindication;
4. Pregnancy, pregnant or lactating women;
5. current or former smokers, smoking history more than 10 pack years;
6. blood routine, urine routine, blood biochemical abnormalities; alanine aminotransferase / aspartate aminotransferase (ALT/AST) exceeds the upper limit of normal 2 times greater than 1.5 times the upper limit of normal serum bilirubin, serum creatinine greater than 1.2 times the upper limit of normal;
7. patients in the 1 months before the screening period in 6 half lives of other clinical research or the research study on the washout period is still in a drug, whichever is longer.

Sub study 3: No.

Age minimum: 18
Age maximum: 60
Gender: Both

Health Condition(s) or Problem(s) studied

asthma

Intervention(s)

1:fluticasone250ug/sustained-release theophylline0.2g;2:fluticasone250ug/procaterol tablet25ug ;3:fluticasone250ug/salmeterol50ug ;4:dexamethasone injection 0.15mg/Kg / theophylline injection 0.25g ;5:prednisone tablets1mg/kg plus salbutamol aerosol 400ug ;

Primary Outcome(s)

Control rate of asthma;Time of remision;

Source(s) of Monetary Support

National Science and technology support program (2014BAI08B00)