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The Effect of Theophylline in the Treatment of Bronchiectasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01684683
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : March 11, 2015
Information provided by (Responsible Party):
Xugang, 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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: Theophylline Drug: Placebo(for Theophylline) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) Bronchiectasis
Study Start Date : November 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Theophylline
Theophylline sustained-release tablet by mouth 100mg every 12hours for 24weeks
Drug: Theophylline
Theophylline 0.1 bid
Other Name: Theophylline Sustained-Release Tablet.

Placebo Comparator: placebo
Placebo(for Theophylline sustained-release tablet) tablet by mouth 100mg every 12hours for 24weeks
Drug: Placebo(for Theophylline)
Starch tablet manufactured to Theophylline 100mg (Theophylline Stained-Release Tablet)

Primary Outcome Measures :
  1. Scores of the St.George's Respiratory Questionnaire [ Time Frame: At 24 weeks ]

Secondary Outcome Measures :
  1. The Number of Exacerbations [ Time Frame: At 24 weeks ]
  2. Scores of The Leicester Cough Questionnaire [ Time Frame: At 24 weeks ]
  3. 24 Hour Sputum Volume [ Time Frame: Every day for 24 weeks ]
  4. Activity of histone deacetylase(HDAC) [ Time Frame: At 24 weeks ]
    HDACs are extracted from cells in blood.

  5. Activity of histone acetyltransferase(HAT) [ Time Frame: At 24 weeks ]
    HATs are extracted from cells in blood.

  6. Lung function [ Time Frame: At 24 weeks ]
    Lung function as measured by FEV1, FVC, FEV1%, FEV1/FVC, FEF25-75 values following American Thoracic Society(ATS) guidelines

  7. Induced sputum culture [ Time Frame: At 24 weeks ]
  8. Induced Sputum Cytology Count [ Time Frame: At 24 weeks ]
  9. Interleukin-6(IL-6) [ Time Frame: At 24 weeks ]
    Test IL-6 both in blood and sputum.

  10. C-Reactive Protein [ Time Frame: At 24 weeks ]
  11. To evaluate change in patients' Clinical Data [ Time Frame: Every day for 24 weeks ]
    Clinical Data contain dyspnea, cough, wheezes, hemoptysis, sputum characteristics, sputum volume.

  12. Number of participants with adverse events [ Time Frame: 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.

  13. Plasma Concentration of Theophylline [ Time Frame: 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)

  14. IL-8 [ Time Frame: At 24 weeks ]
    Test IL-8 both in blood and sputum.

  15. IL-10 [ Time Frame: At 24 weeks ]
    Test IL-10 both in blood and sputum.

  16. Human Tumor Necrosis Factor α(TNF-α) [ Time Frame: At 24 weeks ]
    Test TNF-α both in blood and sputum.

  17. 8-Isoprostane [ Time Frame: At 24 weeks ]
  18. Blood routine examination [ Time Frame: At 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01684683

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China, Guangdong
State Key Laboratory of Respiratory Research Institute.
Guangzhou City, Guangdong, China, 510000
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
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Study Director: Chen Rongchang, Professor institute vice director
Study Director: Zhong Nanshan, Professor institute director
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Responsible Party: Xugang, Doctor of Medicine, The First Affiliated Hospital of Guangzhou Medical University Identifier: NCT01684683    
Other Study ID Numbers: theophylline in NCFB
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Xugang, The First Affiliated Hospital of Guangzhou Medical University:
Therapeutic Uses
Random placebo study
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents