The Effect of Theophylline in the Treatment of Bronchiectasis

Phase 4

Completed

• Conditions: Bronchiectasis
• Interventions: Drug: Placebo(for Theophylline); Drug: Theophylline

• Registration Number: NCT01684683
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-13
• Study Start: 2012-11
• Primary Completion: 2014-04
• Study Completion: 2014-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients between 18-70 years old with non-CF bronchiectasis ,free from acute exacerbations for at least 3 months.Stable phase of the disease.

Exclusion Criteria

• Patients with a cigarette smoking history of more than 10 packs-year. Patients with COPD. Patients with traction bronchiectasis due to advanced fibrosis. Patients with known intolerance for theophylline. Patients with asthma. Patients with other disease disturbing outcomes of the trials. Patients without consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo(for Theophylline)	Placebo(for Theophylline sustained-release tablet) tablet by mouth 100mg every 12hours for 24weeks
Theophylline	Theophylline	Theophylline sustained-release tablet by mouth 100mg every 12hours for 24weeks

Primary Outcome Measures

Name	Time	Method
Scores of the St.George's Respiratory Questionnaire	At 24 weeks

Secondary Outcome Measures

Name	Time	Method
IL-8	At 24 weeks	Test IL-8 both in blood and sputum.
24 Hour Sputum Volume	Every day for 24 weeks
Activity of histone deacetylase(HDAC)	At 24 weeks	HDACs are extracted from cells in blood.
The Number of Exacerbations	At 24 weeks
Scores of The Leicester Cough Questionnaire	At 24 weeks
Activity of histone acetyltransferase(HAT)	At 24 weeks	HATs are extracted from cells in blood.
Lung function	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	At 24 weeks
Induced Sputum Cytology Count	At 24 weeks
Interleukin-6(IL-6)	At 24 weeks	Test IL-6 both in blood and sputum.
C-Reactive Protein	At 24 weeks
To evaluate change in patients' Clinical Data	Every day for 24 weeks	Clinical Data contain dyspnea, cough, wheezes, hemoptysis, sputum characteristics, sputum volume.
Number of participants with adverse events	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	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-10	At 24 weeks	Test IL-10 both in blood and sputum.
Human Tumor Necrosis Factor α（TNF-α)	At 24 weeks	Test TNF-α both in blood and sputum.
8-Isoprostane	At 24 weeks
Blood routine examination	At 24 weeks

Trial Locations

Locations (1)

State Key Laboratory of Respiratory Research Institute.; 🇨🇳 Guangzhou City, Guangdong, China