The Effect of Theophylline in the Treatment of Bronchiectasis
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|ClinicalTrials.gov Identifier: NCT01684683|
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : March 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bronchiectasis||Drug: Theophylline Drug: Placebo(for Theophylline)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Clinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) Bronchiectasis|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||September 2014|
Theophylline sustained-release tablet by mouth 100mg every 12hours for 24weeks
Theophylline 0.1 bid
Other Name: Theophylline Sustained-Release Tablet.
Placebo Comparator: placebo
Placebo(for Theophylline sustained-release tablet) tablet by mouth 100mg every 12hours for 24weeks
Drug: Placebo(for Theophylline)
Starch tablet manufactured to Theophylline 100mg (Theophylline Stained-Release Tablet)
- Scores of the St.George's Respiratory Questionnaire [ Time Frame: At 24 weeks ]
- The Number of Exacerbations [ Time Frame: At 24 weeks ]
- Scores of The Leicester Cough Questionnaire [ Time Frame: At 24 weeks ]
- 24 Hour Sputum Volume [ Time Frame: Every day for 24 weeks ]
- Activity of histone deacetylase(HDAC) [ Time Frame: At 24 weeks ]HDACs are extracted from cells in blood.
- Activity of histone acetyltransferase(HAT) [ Time Frame: At 24 weeks ]HATs are extracted from cells in blood.
- Lung function [ Time Frame: At 24 weeks ]Lung function as measured by FEV1, FVC, FEV1%, FEV1/FVC, FEF25-75 values following American Thoracic Society(ATS) guidelines
- Induced sputum culture [ Time Frame: At 24 weeks ]
- Induced Sputum Cytology Count [ Time Frame: At 24 weeks ]
- Interleukin-6(IL-6) [ Time Frame: At 24 weeks ]Test IL-6 both in blood and sputum.
- C-Reactive Protein [ Time Frame: At 24 weeks ]
- To evaluate change in patients' Clinical Data [ Time Frame: Every day for 24 weeks ]Clinical Data contain dyspnea, cough, wheezes, hemoptysis, sputum characteristics, sputum volume.
- Number of participants with adverse events [ Time Frame: Up to 24 weeks ]Adverse events may contain symptoms such as nausea, sickness, headache, insomnia, palpitation, arrhythmia and so on. Record the symptoms and times of the patients.
- Plasma Concentration of Theophylline [ Time Frame: At 24 weeks ]Venous blood was taken for plasma theophylline at the end of the treatment period. (At the very time of 2 hours after patients taken the pills)
- IL-8 [ Time Frame: At 24 weeks ]Test IL-8 both in blood and sputum.
- IL-10 [ Time Frame: At 24 weeks ]Test IL-10 both in blood and sputum.
- Human Tumor Necrosis Factor α（TNF-α) [ Time Frame: At 24 weeks ]Test TNF-α both in blood and sputum.
- 8-Isoprostane [ Time Frame: At 24 weeks ]
- Blood routine examination [ Time Frame: At 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684683
|State Key Laboratory of Respiratory Research Institute.|
|Guangzhou City, Guangdong, China, 510000|
|Study Director:||Chen Rongchang, Professor||institute vice director|
|Study Director:||Zhong Nanshan, Professor||institute director|