Clinical trial NCT01684683: The Effect of Theophylline in the Treatment of Bronchiectasis
Official title: Clinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchiectasis
Keywords: Bronchiectasis
Theophylline
Therapeutic Uses
HDAC
HAT
Random placebo study
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2012-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Scores of the St.George's Respiratory Questionnaire
timeFrame: At 24 weeks
Secondary outcomes:
measure: The Number of Exacerbations
timeFrame: At 24 weeks
measure: Scores of The Leicester Cough Questionnaire
timeFrame: At 24 weeks
measure: 24 Hour Sputum Volume
timeFrame: Every day for 24 weeks
measure: Activity of histone deacetylase(HDAC)
timeFrame: At 24 weeks
measure: Activity of histone acetyltransferase(HAT)
timeFrame: At 24 weeks
measure: Lung function
timeFrame: At 24 weeks
measure: Induced sputum culture
timeFrame: At 24 weeks
measure: Induced Sputum Cytology Count
timeFrame: At 24 weeks
measure: Interleukin-6(IL-6)
timeFrame: At 24 weeks
measure: C-Reactive Protein
timeFrame: At 24 weeks
measure: To evaluate change in patients' Clinical Data
timeFrame: Every day for 24 weeks
measure: Number of participants with adverse events
timeFrame: Up to 24 weeks
measure: Plasma Concentration of Theophylline
timeFrame: At 24 weeks
measure: IL-8
timeFrame: At 24 weeks
measure: IL-10
timeFrame: At 24 weeks
measure: Human Tumor Necrosis Factor α（TNF-α)
timeFrame: At 24 weeks
measure: 8-Isoprostane
timeFrame: At 24 weeks
measure: Blood routine examination
timeFrame: At 24 weeks
Other outcomes:
Locations:
city: Guangzhou City
country: China
facility: State Key Laboratory of Respiratory Research Institute.
state: Guangdong
Study officials:
affiliation: institute vice director
name: Chen Rongchang, Professor
role: STUDY_DIRECTOR
affiliation: institute director
name: Zhong Nanshan, Professor
role: STUDY_DIRECTOR
References: