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The Effect of Theophylline in the Treatment of Bronchiectasis

Information source: The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchiectasis

Intervention: Theophylline (Drug); Placebo(for Theophylline) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: The First Affiliated Hospital of Guangzhou Medical University

Official(s) and/or principal investigator(s):
Chen Rongchang, Professor, Study Director, Affiliation: institute vice director
Zhong Nanshan, Professor, Study Director, Affiliation: institute director

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.

Clinical Details

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

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

Primary outcome: Scores of the St.George's Respiratory Questionnaire

Secondary outcome:

The Number of Exacerbations

Scores of The Leicester Cough Questionnaire

24 Hour Sputum Volume

Activity of histone deacetylase(HDAC)

Activity of histone acetyltransferase(HAT)

Lung function

Induced sputum culture

Induced Sputum Cytology Count

Interleukin-6(IL-6)

C-Reactive Protein

To evaluate change in patients' Clinical Data

Number of participants with adverse events

Plasma Concentration of Theophylline

IL-8

IL-10

Human Tumor Necrosis Factor α(TNF-α)

8-Isoprostane

Blood routine examination

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

State Key Laboratory of Respiratory Research Institute., Guangzhou City, Guangdong 510000, China
Additional Information

Starting date: November 2012
Last updated: March 10, 2015

Page last updated: August 23, 2015

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