Theophylline was well recommended in the treatment of chronic obstructive pulmonary disease (COPD) and asthma. However, there is no supporting evidence for their efficacy in the treatment of bronchiectasis. Our hypothesis is that theophylline will play a role in bronchiectasis. Our purpose is to examine the efficacy and safety of 24 weeks treatment with theophylline in subjects with non-cystic fibrosis bronchiectasis.
For the reasons of lack of sufficient clinical trial evidences, there are no standard therapy recommendations for bronchiectasis. Currently the treatments for bronchiectasis are mostly based on experience gained from the treatment of COPD and cystic fibrosis(CF). The aims of treatment for bronchiectasis are to improve the health-related quality of life, to slow down the decrease of lung function, to reduce the exacerbation frequence and the mortality. The mechanism of treatment are including: treating the underlying disease; improving drainage of sputum; anti-infection; anti-inflammation; treating airway obstruction. A review written by Peter J. Barnes describes that as a bronchodilator in COPD, theophylline may relax human airways smooth muscle, have an anti-inflammation rols, and have an additional effect on mucociliary clearance. Besides, theophylline can improve the activity of histone deacetylase, which will reverse the resistant of corticosteroids. We hypothesis that theophylline will have the same effect in subjects with NCF-bronchiectasis as in subjects with COPD. Our trial may give an evidence of using theophylline in treatment of bronchiectasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Theophylline 0.1 bid
Starch tablet manufactured to Theophylline 100mg (Theophylline Stained-Release Tablet)
State Key Laboratory of Respiratory Research Institute.
Guangzhou, Guangdong, China
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)
HDACs are extracted from cells in blood.
Time frame: At 24 weeks
Activity of histone acetyltransferase(HAT)
HATs are extracted from cells in blood.
Time frame: At 24 weeks
Lung function
Lung function as measured by FEV1, FVC, FEV1%, FEV1/FVC, FEF25-75 values following American Thoracic Society(ATS) guidelines
Time frame: At 24 weeks
Induced sputum culture
Time frame: At 24 weeks
Induced Sputum Cytology Count
Time frame: At 24 weeks
Interleukin-6(IL-6)
Test IL-6 both in blood and sputum.
Time frame: At 24 weeks
C-Reactive Protein
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At 24 weeks
To evaluate change in patients' Clinical Data
Clinical Data contain dyspnea, cough, wheezes, hemoptysis, sputum characteristics, sputum volume.
Time frame: Every day for 24 weeks
Number of participants with adverse events
Adverse events may contain symptoms such as nausea, sickness, headache, insomnia, palpitation, arrhythmia and so on. Record the symptoms and times of the patients.
Time frame: Up to 24 weeks
Plasma Concentration of Theophylline
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)
Time frame: At 24 weeks
IL-8
Test IL-8 both in blood and sputum.
Time frame: At 24 weeks
IL-10
Test IL-10 both in blood and sputum.
Time frame: At 24 weeks
Human Tumor Necrosis Factor α（TNF-α)
Test TNF-α both in blood and sputum.
Time frame: At 24 weeks
8-Isoprostane
Time frame: At 24 weeks
Blood routine examination
Time frame: At 24 weeks