The Effect of Theophylline in the Treatment of Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

Clinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) Bronchiectasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684683
• Other study ID #: theophylline in NCFB
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2012
• Last updated: March 10, 2015
• Start date: November 2012
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• Theophylline
Theophylline 0.1 bid
• Placebo(for Theophylline)
Starch tablet manufactured to Theophylline 100mg (Theophylline Stained-Release Tablet)

Locations

Country	Name	City	State
China	State Key Laboratory of Respiratory Research Institute.	Guangzhou City	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores of the St.George's Respiratory Questionnaire		At 24 weeks	No
Secondary	The Number of Exacerbations		At 24 weeks	No
Secondary	Scores of The Leicester Cough Questionnaire		At 24 weeks	No
Secondary	24 Hour Sputum Volume		Every day for 24 weeks	No
Secondary	Activity of histone deacetylase(HDAC)	HDACs are extracted from cells in blood.	At 24 weeks	No
Secondary	Activity of histone acetyltransferase(HAT)	HATs are extracted from cells in blood.	At 24 weeks	No
Secondary	Lung function	Lung function as measured by FEV1, FVC, FEV1%, FEV1/FVC, FEF25-75 values following American Thoracic Society(ATS) guidelines	At 24 weeks	No
Secondary	Induced sputum culture		At 24 weeks	No
Secondary	Induced Sputum Cytology Count		At 24 weeks	No
Secondary	Interleukin-6(IL-6)	Test IL-6 both in blood and sputum.	At 24 weeks	No
Secondary	C-Reactive Protein		At 24 weeks	No
Secondary	To evaluate change in patients' Clinical Data	Clinical Data contain dyspnea, cough, wheezes, hemoptysis, sputum characteristics, sputum volume.	Every day for 24 weeks	No
Secondary	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.	Up to 24 weeks	Yes
Secondary	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)	At 24 weeks	Yes
Secondary	IL-8	Test IL-8 both in blood and sputum.	At 24 weeks	No
Secondary	IL-10	Test IL-10 both in blood and sputum.	At 24 weeks	No
Secondary	Human Tumor Necrosis Factor a(TNF-a)	Test TNF-a both in blood and sputum.	At 24 weeks	No
Secondary	8-Isoprostane		At 24 weeks	No
Secondary	Blood routine examination		At 24 weeks	No