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Completed

NCT Number: NCT01684683

The Effect of Theophylline in the Treatment of Bronchiectasis

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.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

State Key Laboratory of Respiratory Research Institute.

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Theophylline

Drug

Theophylline 0.1 bid

Other names: Theophylline Sustained-Release Tablet.

Placebo(for Theophylline)

Drug

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

Primary outcomes

  1. Scores of the St.George's Respiratory Questionnaire

    Time frame: At 24 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2012
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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