The Effect of Theophylline in the Treatment of Bronchiectasis

NCT ID: NCT01684683

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-09-30

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.

Conditions

Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Theophylline

Theophylline sustained-release tablet by mouth 100mg every 12hours for 24weeks

Group Type: EXPERIMENTAL

Theophylline

Intervention Type: DRUG

Theophylline 0.1 bid

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo(for Theophylline)

Intervention Type: DRUG

Starch tablet manufactured to Theophylline 100mg (Theophylline Stained-Release Tablet)

Interventions

Theophylline

Theophylline 0.1 bid

Intervention Type: DRUG

Placebo(for Theophylline)

Starch tablet manufactured to Theophylline 100mg (Theophylline Stained-Release Tablet)

Intervention Type: DRUG

Other Intervention Names

Theophylline Sustained-Release Tablet.

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xugang

Doctor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen Rongchang, Professor

Role: STUDY_DIRECTOR

institute vice director

Zhong Nanshan, Professor

Role: STUDY_DIRECTOR

institute director

Locations

State Key Laboratory of Respiratory Research Institute.

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

theophylline in NCFB

Identifier Type: -

Identifier Source: org_study_id