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Register:	ClinicalTrials.gov
Last refreshed on:	23 March 2015
Main ID:	NCT01684683
Date of registration:	11/09/2012
Prospective Registration:	Yes
Primary sponsor:	The First Affiliated Hospital of Guangzhou Medical University
Public title:	The Effect of Theophylline in the Treatment of Bronchiectasis
Scientific title:	Clinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) Bronchiectasis
Date of first enrolment:	November 2012
Target sample size:	100
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT01684683
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
Phase:	Phase 4

Countries of recruitment
China

Contacts

Name:	Zhong Nanshan, Professor
Address:
Telephone:
Email:
Affiliation:	institute director

Name:	Chen Rongchang, Professor
Address:
Telephone:
Email:
Affiliation:	institute vice director

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bronchiectasis

Intervention(s)

Drug: Placebo(for Theophylline)

Drug: Theophylline

Primary Outcome(s)

Scores of the St.George's Respiratory Questionnaire [Time Frame: At 24 weeks]

Secondary Outcome(s)

Lung function [Time Frame: At 24 weeks]

Scores of The Leicester Cough Questionnaire [Time Frame: At 24 weeks]

IL-10 [Time Frame: At 24 weeks]

Number of participants with adverse events [Time Frame: Up to 24 weeks]

Human Tumor Necrosis Factor a(TNF-a) [Time Frame: At 24 weeks]

Activity of histone deacetylase(HDAC) [Time Frame: At 24 weeks]

24 Hour Sputum Volume [Time Frame: Every day for 24 weeks]

8-Isoprostane [Time Frame: At 24 weeks]

Blood routine examination [Time Frame: At 24 weeks]

C-Reactive Protein [Time Frame: At 24 weeks]

IL-8 [Time Frame: At 24 weeks]

Plasma Concentration of Theophylline [Time Frame: At 24 weeks]

Induced Sputum Cytology Count [Time Frame: At 24 weeks]

The Number of Exacerbations [Time Frame: At 24 weeks]

Activity of histone acetyltransferase(HAT) [Time Frame: At 24 weeks]

Induced sputum culture [Time Frame: At 24 weeks]

Interleukin-6(IL-6) [Time Frame: At 24 weeks]

To evaluate change in patients' Clinical Data [Time Frame: Every day for 24 weeks]

Secondary ID(s)

theophylline in NCFB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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