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Completed

NCT Number: NCT01769898

The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis

The purpose of this study is to examine the efficacy and safety of 24 weeks treatment with theophylline plus low-dose formoterol-budesonide in subjects with 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, China

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About this study

Non-cystic fibrosis bronchiectasis is an orphan disease caused by the pathogenic vicious circle including infection, inflammation and airway repair. Today's principle of treatment is to break the cycle of inflammation and infection. Nowadays, most clinical trials are anti-infective treatment by antibiotics trying to break this cycle by reducing the bacterial load, which may cause bacterial resistance. There were still some anti-inflammation trials by using inhaled corticosteroids(ICS). Tsang and Martínez-García showed that inhaled corticosteroids reduced IL-1,IL-8 levels and sputum inflammation cells, and improved sputum volume as well as quality of life, though the corticosteroid must be high dose or medium dose combined with long-acting ß2 adrenergic agonists. As described in asthma and chronic obstructive pulmonary disease(COPD), theophylline can improve the activity of histone deacetylase (HDAC) and then enhanced the anti-inflammatory effect of steroids. We hypothesis that theophylline may have the same effect in subjects with bronchiectasis. Theophylline plus inhaled low-dose formoterol-budesonide may improve quality of life and reduce airway inflammation.

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-cystic fibrosis(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

Formoterol-budesonide

Drug

Formoterol-budesonide combined treatment (4.5µg/160µg Q12H)

Other names: Symbicort tu rbuhaler

Theophylline

Drug

Theophylline 0.1 Q12H

Other names: Theophylline Sustained-Release Tablet

Placebo

Drug

Placebo for theophylline 0.1 Q12H

Primary outcomes

  1. Quality of Life Assessment with St George's Respiratory Questionnaire(SGRQ) and Leicester Cough Questionnaire(LCQ)

    Time frame: Baseline and 24 weeks

Secondary outcomes

  1. Mean number of exacerbations per patient per 24 weeks

    Time frame: Baseline and 24 weeks

    Exacerbations defined by persistent (≥ 24 h) deterioration in at least three respiratory symptoms, including cough, dyspnea, hemoptysis, increased sputum purulence or volume, chest pain (with or without fever).

  2. Changes of sputum characteristics from baseline to 24 weeks

    Time frame: Baseline and 24 weeks

  3. Changes of 24 hour sputum volume from baseline to 24 weeks

    Time frame: Baseline and 24 weeks

  4. Changes of forced expiratory volume in 1 second(FEV1) from baseline to 24 weeks

    Time frame: Baseline and 24 weeks

  5. Changes of mean forced expiratory flow between 25% and 75% of the FVC(FEF25-75)from baseline to 24 weeks

    Time frame: Baseline and 24 weeks

  6. Changes of forced vital capacity(FVC) from baseline to 24 weeks

    Time frame: Baseline and 24 weeks

  7. Changes of peak expiratory flow(PEF) from baseline to 24 weeks

    Time frame: Baseline and 24 weeks

  8. Induced sputum cytology count

    Time frame: Baseline and 24 weeks

  9. Changes of sputum culture from baseline to 24 weeks

    Time frame: Baseline and 24 weeks

  10. IL-6

    Time frame: Baseline and 24 weeks

    Test IL-6 both in blood and sputum.

  11. IL-8

    Time frame: Baseline and 24 weeks

    Test IL-8 both in blood and sputum.

  12. IL-10

    Time frame: At 24 weeks

    Test IL-10 both in blood and sputum.

  13. Tumor necrosis factor(TNF)α

    Time frame: Baseline and 24 weeks

    Test TNF-α both in blood and sputum.

  14. Activity of histone deacetylase(HDAC)

    Time frame: Baseline and 24 weeks

    HDACs are extracted from cells in blood.

  15. Activity of histone acetyltransferase(HAT)

    Time frame: Baseline and 24 weeks

    HATs are extracted from cells in blood.

  16. 8-Isoprostane

    Time frame: Baseline and 24 weeks

  17. Neutrophilic granulocytes in blood routine examination

    Time frame: Baseline and 24 weeks

  18. White blood cells in blood routine examination

    Time frame: Baseline and 24 weeks

  19. Monocytes in blood routine examination

    Time frame: Baseline and 24 weeks

  20. Eosinophilic granulocytes in blood routine examination

    Time frame: Baseline and 24 weeks

  21. Number of participants with Adverse events as a measure of safety and tolerability

    Time frame: 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.

  22. Plasma Concentration of Theophylline

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 17, 2013
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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