A Phase 4 interventional study of Formoterol-budesonide and Theophylline in Bronchiectasis, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Completed at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-11.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Phase 4, Interventional, and Treatment
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.
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.
373 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.
This study's enrollment of 50 is below the median of 59 across 238 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 165 studies on the registry; 67 are open to participants now.
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Exclusion Criteria:
Placebo(for Theophylline sustained-release tablet) tablet by mouth 100mg every 12hours for 24weeks. Inhaled Formoterol-budesonide combined treatment 4.5µg/160µg every 12hours for 24weeks.
Drug: Formoterol-budesonide · Drug: Placebo
Theophylline sustained-release tablet by mouth 100mg every 12hours for 24weeks. Inhaled formoterol-budesonide combined treatment 4.5µg/160µg every 12hours for 24weeks.
Drug: Formoterol-budesonide · Drug: Theophylline
Formoterol-budesonide combined treatment (4.5µg/160µg Q12H)
Also known as: Symbicort tu rbuhaler
Theophylline 0.1 Q12H
Also known as: Theophylline Sustained-Release Tablet
Placebo for theophylline 0.1 Q12H
Quality of Life Assessment with St George's Respiratory Questionnaire(SGRQ) and Leicester Cough Questionnaire(LCQ)
Time frame: Baseline and 24 weeks
Mean number of exacerbations per patient per 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).
Time frame: Baseline and 24 weeks
Changes of sputum characteristics from baseline to 24 weeks
Time frame: Baseline and 24 weeks
Changes of 24 hour sputum volume from baseline to 24 weeks
Time frame: Baseline and 24 weeks
Changes of forced expiratory volume in 1 second(FEV1) from baseline to 24 weeks
Time frame: Baseline and 24 weeks
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
Changes of forced vital capacity(FVC) from baseline to 24 weeks
Time frame: Baseline and 24 weeks
Changes of peak expiratory flow(PEF) from baseline to 24 weeks
Time frame: Baseline and 24 weeks
Induced sputum cytology count
Time frame: Baseline and 24 weeks
Changes of sputum culture from baseline to 24 weeks
Time frame: Baseline and 24 weeks
IL-6
Test IL-6 both in blood and sputum.
Time frame: Baseline and 24 weeks
IL-8
Test IL-8 both in blood and sputum.
Time frame: Baseline and 24 weeks
IL-10
Test IL-10 both in blood and sputum.
Time frame: At 24 weeks
Tumor necrosis factor(TNF)α
Test TNF-α both in blood and sputum.
Time frame: Baseline and 24 weeks
Activity of histone deacetylase(HDAC)
HDACs are extracted from cells in blood.
Time frame: Baseline and 24 weeks
Activity of histone acetyltransferase(HAT)
HATs are extracted from cells in blood.
Time frame: Baseline and 24 weeks
8-Isoprostane
Time frame: Baseline and 24 weeks
Neutrophilic granulocytes in blood routine examination
Time frame: Baseline and 24 weeks
White blood cells in blood routine examination
Time frame: Baseline and 24 weeks
Monocytes in blood routine examination
Time frame: Baseline and 24 weeks
Eosinophilic granulocytes in blood routine examination
Time frame: Baseline and 24 weeks
Number of participants with Adverse events as a measure of safety and tolerability
Adverse events may contain symptoms such as nausea, sickness, headache, insomnia, palpitation, arrhythmia and so on. Record the symptoms and times of the patients.
Time frame: 24 weeks
Plasma Concentration of Theophylline
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)
Time frame: 24 weeks
The record gives a start of Jul 2013, a primary completion of Sep 2014 and a completion of Nov 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Theophylline
The First Affiliated Hospital of Guangzhou Medical University →