BronchiectasisPhase 4NCT01684683
The Effect of Theophylline in the Treatment of Bronchiectasis
A Phase 4 study testing Theophylline in people with Bronchiectasis, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Theophylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Sep 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18-70 years old with non-CF bronchiectasis ,free from acute exacerbations for at least 3 months.Stable phase of the disease.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
State Key Laboratory of Respiratory Research Institute.
Guangzhou, Guangdong, 510000
About this study
Official title: Clinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) Bronchiectasis
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.
Read the 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.
- Conditions
- Bronchiectasis
- Being tested
- Theophylline, Placebo(for Theophylline)
- Keywords
- Bronchiectasis, Theophylline, Therapeutic Uses, HDAC, HAT, Random placebo study
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheophyllineDrug
Also called Theophylline Sustained-Release Tablet.
Theophylline 0.1 bid
Placebo(for Theophylline)Drug
Starch tablet manufactured to Theophylline 100mg (Theophylline Stained-Release Tablet)
| Study group | Role | What they receive |
|---|---|---|
| Theophylline | Experimental | Theophylline sustained-release tablet by mouth 100mg every 12hours for 24weeks Receives: Drug: Theophylline |
| placebo | Placebo comparator | Placebo(for Theophylline sustained-release tablet) tablet by mouth 100mg every 12hours for 24weeks Receives: Drug: Placebo(for Theophylline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores of the St.George's Respiratory Questionnaire
Measured: At 24 weeks
Secondary outcomes (18)
The Number of Exacerbations
Measured: At 24 weeks
Scores of The Leicester Cough Questionnaire
Measured: At 24 weeks
24 Hour Sputum Volume
Measured: Every day for 24 weeks
Activity of histone deacetylase(HDAC)
HDACs are extracted from cells in blood.
Measured: At 24 weeks
Activity of histone acetyltransferase(HAT)
HATs are extracted from cells in blood.
Measured: At 24 weeks
Lung function
Lung function as measured by FEV1, FVC, FEV1%, FEV1/FVC, FEF25-75 values following American Thoracic Society(ATS) guidelines
Measured: At 24 weeks
Induced sputum culture
Measured: At 24 weeks
Induced Sputum Cytology Count
Measured: At 24 weeks
Interleukin-6(IL-6)
Test IL-6 both in blood and sputum.
Measured: At 24 weeks
C-Reactive Protein
Measured: At 24 weeks
To evaluate change in patients' Clinical Data
Clinical Data contain dyspnea, cough, wheezes, hemoptysis, sputum characteristics, sputum volume.
Measured: Every day for 24 weeks
Number of participants with adverse events
Adverse events may contain symptoms such as nausea, sickness, headache, insomnia, palpitation, arrhythmia and so on. Record the symptoms and times of the patients.
Measured: Up to 24 weeks
Plasma Concentration of Theophylline
Venous blood was taken for plasma theophylline at the end of the treatment period. (At the very time of 2 hours after patients taken the pills)
Measured: At 24 weeks
IL-8
Test IL-8 both in blood and sputum.
Measured: At 24 weeks
IL-10
Test IL-10 both in blood and sputum.
Measured: At 24 weeks
Human Tumor Necrosis Factor α（TNF-α)
Test TNF-α both in blood and sputum.
Measured: At 24 weeks
8-Isoprostane
Measured: At 24 weeks
Blood routine examination
Measured: At 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xugang, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Chen Rongchang, Professor, Study director, institute vice directorZhong Nanshan, Professor, Study director, institute director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684683
- Sponsor's protocol ID
- theophylline in NCFB
- Status last verified
- Mar 2015
- First submitted
- 11 Sep 2012
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) Bronchiectasis
- ClinicalTrials.gov ID
- NCT01684683
- Acronym / sponsor ID
- theophylline in NCFB
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Theophylline, Therapeutic Uses, HDAC, HAT, Random placebo study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theophylline | Experimental | Drug: TheophyllineTheophylline sustained-release tablet by mouth 100mg every 12hours for 24weeks |
| placebo | Placebo comparator | Drug: Placebo(for Theophylline)Placebo(for Theophylline sustained-release tablet) tablet by mouth 100mg every 12hours for 24weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between 18-70 years old with non-CF bronchiectasis ,free from acute exacerbations for at least 3 months.Stable phase of the disease.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheophyllineAlso: Theophylline Sustained-Release Tablet.Theophylline 0.1 bid | Drug | Theophylline |
| Placebo(for Theophylline)Starch tablet manufactured to Theophylline 100mg (Theophylline Stained-Release Tablet) | Drug | placebo |
Primary outcome
Scores of the St.George's Respiratory Questionnaire
Time frame: At 24 weeks
18 secondary outcomes
The Number of Exacerbations
Time frame: At 24 weeks
Scores of The Leicester Cough Questionnaire
Time frame: At 24 weeks
24 Hour Sputum Volume
Time frame: Every day for 24 weeks
Activity of histone deacetylase(HDAC)
Time frame: At 24 weeks
Activity of histone acetyltransferase(HAT)
Time frame: At 24 weeks
Lung function
Time frame: At 24 weeks
Induced sputum culture
Time frame: At 24 weeks
Induced Sputum Cytology Count
Time frame: At 24 weeks
Interleukin-6(IL-6)
Time frame: At 24 weeks
C-Reactive Protein
Time frame: At 24 weeks
To evaluate change in patients' Clinical Data
Time frame: Every day for 24 weeks
Number of participants with adverse events
Time frame: Up to 24 weeks
Plasma Concentration of Theophylline
Time frame: At 24 weeks
IL-8
Time frame: At 24 weeks
IL-10
Time frame: At 24 weeks
Human Tumor Necrosis Factor α（TNF-α)
Time frame: At 24 weeks
8-Isoprostane
Time frame: At 24 weeks
Blood routine examination
Time frame: At 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Rongchang, Professor study director
institute vice director
Zhong Nanshan, Professor study director
institute director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Theophylline in people with Bronchiectasis, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores of the St.George's Respiratory Questionnaire (time frame: At 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.