NCT01684683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

1.4 years

First QC Date

September 11, 2012

Last Update Submit

March 10, 2015

Conditions

Bronchiectasis

Keywords

BronchiectasisTheophyllineTherapeutic UsesHDACHATRandom placebo study

Outcome Measures

Primary Outcomes (1)

  • Scores of the St.George's Respiratory Questionnaire

    At 24 weeks

Secondary Outcomes (18)

  • The Number of Exacerbations

    At 24 weeks

  • Scores of The Leicester Cough Questionnaire

    At 24 weeks

  • 24 Hour Sputum Volume

    Every day for 24 weeks

  • Activity of histone deacetylase(HDAC)

    At 24 weeks

  • Activity of histone acetyltransferase(HAT)

    At 24 weeks

  • +13 more secondary outcomes

Study Arms (2)

Theophylline

EXPERIMENTAL

Theophylline sustained-release tablet by mouth 100mg every 12hours for 24weeks

Drug: Theophylline

placebo

PLACEBO COMPARATOR

Placebo(for Theophylline sustained-release tablet) tablet by mouth 100mg every 12hours for 24weeks

Drug: Placebo(for Theophylline)

Interventions

TheophyllineDRUG

Theophylline 0.1 bid

Also known as: Theophylline Sustained-Release Tablet.
Theophylline
Placebo(for Theophylline)DRUG

Starch tablet manufactured to Theophylline 100mg (Theophylline Stained-Release Tablet)

placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18-70 years old with non-CF bronchiectasis ,free from acute exacerbations for at least 3 months.Stable phase of the disease.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Key Laboratory of Respiratory Research Institute.

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Bronchiectasis

Interventions

Theophylline

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Chen Rongchang, Professor

    institute vice director

    STUDY DIRECTOR

  • Zhong Nanshan, Professor

    institute director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine

Study Record Dates

First Submitted

September 11, 2012

First Posted

September 13, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2014

Study Completion

September 1, 2014

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

CN(1)