The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of BronchiectasisVerified by: The First Affiliated Hospital of Guangzhou Medical University, January 2013
First Received: January 15, 2013 | Last Updated: January 17, 2013
Phase: Phase 4 | Start Date: July 2013
Overall Status: Not yet recruiting | Estimated Enrollment: 60
[h=2]Brief Summary[/h]
Skip to Participation Criteria
Official Title: “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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: June 2014
[h=2]Detailed Clinical Trial Description[/h]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.
[h=2]Interventions Used in this Clinical Trial[/h]
- Drug: Formoterol-budesonide
- Formoterol-budesonide combined treatment (4.5µg/160µg Q12H)
- Drug: Theophylline
- Drug: Placebo
- Placebo for theophylline 0.1 Q12H
[h=2]Arms, Groups and Cohorts in this Clinical Trial[/h]
- Placebo Comparator: Placebo+formoterol-budesonide
- 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.
- Experimental: Theophylline+formoterol-budesonide
- Theophylline sustained-release tablet by mouth 100mg every 12hours for 24weeks. Inhaled formoterol-budesonide combined treatment 4.5µg/160µg every 12hours for 24weeks.
[h=2]Outcome Measures for this Clinical Trial[/h][h=3]Primary Measures[/h]
- Quality of Life Assessment with St George’s Respiratory Questionnaire(SGRQ) and Leicester Cough Questionnaire(LCQ)
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
[h=3]Secondary Measures[/h]
- Mean number of exacerbations per patient per 24 weeks
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Changes of sputum characteristics from baseline to 24 weeks
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Changes of 24 hour sputum volume from baseline to 24 weeks
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Changes of forced expiratory volume in 1 second(FEV1) from baseline to 24 weeks
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- 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
Safety Issue?: No
- Changes of forced vital capacity(FVC) from baseline to 24 weeks
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Changes of peak expiratory flow(PEF) from baseline to 24 weeks
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Induced sputum cytology count
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Changes of sputum culture from baseline to 24 weeks
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Interleukin-1ß(IL-1ß)
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- IL-6
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- IL-8
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- IL-10
- Time Frame: At 24 weeks
Safety Issue?: No
- Tumor necrosis factor(TNF)α
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Activity of histone deacetylase(HDAC)
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Activity of histone acetyltransferase(HAT)
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Superoxide Dismutase
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- 8-Isoprostane
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Neutrophilic granulocytes in blood routine examination
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- White blood cells in blood routine examination
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Monocytes in blood routine examination
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Eosinophilic granulocytes in blood routine examination
- Time Frame: Baseline and 24 weeks
Safety Issue?: No
- Number of participants with Adverse events as a measure of safety and tolerability
- Time Frame: 24 weeks
Safety Issue?: Yes
- Plasma Concentration of Theophylline
- Time Frame: 24 weeks
Safety Issue?: Yes
[h=2]Criteria for Participation in this Clinical Trial[/h]
[h=3]Inclusion Criteria[/h]
- 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.
[h=3]Exclusion Criteria[/h]
- 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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial: No
[h=2]Clinical Trial Investigator Information[/h]
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Provider of Information About this Clinical Study
- Principal Investigator: Xugang, Medical Doctor – The First Affiliated Hospital of Guangzhou Medical University
- Overall Official(s)
- Chen Rongchang, Professor, Study Director, institute vice director
- Zhong Nanshan, Professor, Study Director, institute director
[h=2]Additional Information on this Clinical Trial[/h]Information obtained from ClinicalTrials.gov on February 10, 2013
Link to the current ClinicalTrials.gov record. –
http://clinicaltrials.gov/show/NCT01769898
Study ID Number: theophylline in bronchiectasis
ClinicalTrials.gov Identifier: NCT01769898
Health Authority: China: Ethics Committee
[h=2]Source[/h]Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01769898