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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-TRC-13003979 |
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Date of registration:
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2013-10-28 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Application of roxithromycin in patients with bronchiectasis in stable condition
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Scientific title:
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Effect of low-dose, long-term roxithromycin on airway imflammation and remodeling of stable non-cystic fibrosis bronchiectasis |
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Date of first enrolment:
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2009-05-07 |
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Target sample size:
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Roxithromycin group:26;Control group:26; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=5588 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Post-market
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Countries of recruitment
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China
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Contacts
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Name:
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Xiao-Ning Zhong
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Address:
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22 Shuangyong Road, Nanning, Guangxi, China
530021
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Telephone:
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+86 18260987239 |
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Email:
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xnzhong101@sina.com |
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Affiliation:
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First Affiliated Hospital of Guangxi Medical University |
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Name:
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Ji-Feng Liu
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Address:
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22 Shuangyong Road, Nanning, Guangxi, China
530021
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Telephone:
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+86 13788171736 |
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Email:
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liuzf776@sina.com |
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Affiliation:
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First Affiliated Hospital of Guangxi Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. The diagnosis of all patients with non-cystic fibrosis bronchiectasis was confirmed as bronchiectasis on high-resolution computed tomographic (HRCT) scan of the chest;
2. Aged from 18 years to 70 years;
3. Informed consent was obtained from patient before enrollment.
Exclusion criteria: The patients with exacerbation of bronchiectasis had been excluded according to a protocol-defined exacerbation (PDE) which O'Donnell et al set down. The PDE was prospectively defined as abnormalities in four of the following nine symptoms, signs, or laboratory findings:
1. change in sputum production (consistency, color, volume, or hemoptysis);
2. increased dyspnea (chest congestion or shortness of breath);
3. increased cough;
4. fever (>/=38 degree C);
5. increased wheezing;
6. decreased exercise tolerance, malaise, fatigue, or lethargy;
7. forced expiratory volume in 1 second or forced vital capacity decreased 10% from a previously recorded value;
8. radiographic changes indicative of a new pulmonary process; or
9. changes in chest sounds. Patients with cystic fibrosis (CF), who had documented clinical, radiologic, genotypic features and abnormal sweat test results (sweat sodium and chloride >60mmol/L) [14], had been excluded. Patients who were allergic to macrolides and patients with impaired hepatic disease or diabetes mellitus had also been excluded.
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bronchietasis
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Intervention(s)
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Roxithromycin group:The patients received oral roxithromycin in roxithromycin group;Control group:The patients received no drug in control group;
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Primary Outcome(s)
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Thoracic CT scores;Marker of inflammation in sputum;
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Source(s) of Monetary Support
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The Special Foundation for Chronical Respiratory Disease of Chinese Medical Association (No. 07010150023) and Youth Science Fund of Guangxi Zhuang Autonomous Region in China (No.0991019)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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