NCT01769898

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

2 active sites

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

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

January 15, 2013

Last Update Submit

March 10, 2015

Conditions

Bronchiectasis

Keywords

BronchiectasisTheophyllineTherapeutic UsesHDACHATRandom placebo studyICS(inhaled corticosteroid)corticosteroidInhaled corticosteroid

Outcome Measures

Primary Outcomes (1)

  • Quality of Life Assessment with St George's Respiratory Questionnaire(SGRQ) and Leicester Cough Questionnaire(LCQ)

    Baseline and 24 weeks

Secondary Outcomes (22)

  • Mean number of exacerbations per patient per 24 weeks

    Baseline and 24 weeks

  • Changes of sputum characteristics from baseline to 24 weeks

    Baseline and 24 weeks

  • Changes of 24 hour sputum volume from baseline to 24 weeks

    Baseline and 24 weeks

  • Changes of forced expiratory volume in 1 second(FEV1) from baseline to 24 weeks

    Baseline and 24 weeks

  • Changes of mean forced expiratory flow between 25% and 75% of the FVC(FEF25-75)from baseline to 24 weeks

    Baseline and 24 weeks

  • +17 more secondary outcomes

Study Arms (2)

Placebo+formoterol-budesonide

PLACEBO COMPARATOR

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-budesonideDrug: Placebo

Theophylline+formoterol-budesonide

EXPERIMENTAL

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-budesonideDrug: Theophylline

Interventions

Formoterol-budesonideDRUG

Formoterol-budesonide combined treatment (4.5µg/160µg Q12H)

Also known as: Symbicort tu rbuhaler
Placebo+formoterol-budesonideTheophylline+formoterol-budesonide
TheophyllineDRUG

Theophylline 0.1 Q12H

Also known as: Theophylline Sustained-Release Tablet
Theophylline+formoterol-budesonide
PlaceboDRUG

Placebo for theophylline 0.1 Q12H

Placebo+formoterol-budesonide

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-cystic fibrosis(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 (2)

State Key Laboratory of Respiratory Research Institute.

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital of Guangzhou Medical University

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
Medical Doctor

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2014

Study Completion

November 1, 2014

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

CN(2)