Chronic Obstructive Pulmonary DiseasePhase 4TASCSNCT02261727
Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study
A Phase 4 study testing Theophylline and Prednisone in people with Chronic Obstructive Pulmonary Disease, run by The George Institute at 1 site in Australia.
Trial summary
The aim of this multi-centre, double blind, randomised, controlled trial (DBRCT) is to assess the effect of low dose theophylline, singly and in combination with low dose oral prednisone, on COPD (Chronic Obstructive Pulmonary Disease) exacerbations, quality of life and secondary clinical outcomes compared with usual… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Theophylline and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,670 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2014to 14 May 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current or former smokers (> 10 pack years) or biomass exposure
- 40 - 80 years of age
- Clinical diagnosis of COPD
- Post-bronchodilator FEV1 < 70% predicted
- Post bronchodilator FEV1/FVC ratio < 0.7
Who cannot join
- Life expectancy of less than 12 months
- Exacerbation or respiratory infection within 4 weeks prior to randomisation
- Patient is taking and requires maintenance oral corticosteroids
- Patient is on domiciliary oxygen
- There has been previous pulmonary resection
- Previous sensitivity to, or intolerance of theophylline
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- Coexistent illness precluding participation in the study (epilepsy, chronic liver disease, unstable cardiovascular disease, diabetes, active malignancy)
- Inability to complete quality of life questionnaire
- Concomitant major illness that would interfere with visits, assessments and follow-up
- Have evidence of chronic liver disease, or transaminase or gamma-glutamyltransferase (GGT) elevation > 1.5 x upper limit of normal (ULN)
- Random blood glucose level > 8mmol/L
- High chance in the view of the treating physician that the patient will not adhere to study treatment and follow up
Trial locations and contacts
1 site in 1 country.
Australia1 site
The George Institute for Global Health
Sydney, New South Wales, 2000
About this study
Official title: The Effect of Low-dose Corticosteroids and Theophylline on the Risk of Acute Exacerbations of COPD: the TASCS Randomised Clinical Trial
The aim of this multi-centre, double blind, randomised, controlled trial (DBRCT) is to assess the effect of low dose theophylline, singly and in combination with low dose oral prednisone, on COPD (Chronic Obstructive Pulmonary Disease) exacerbations, quality of life and secondary clinical outcomes compared with usual therapy and placebo over 48 weeks of treatment. 1670 symptomatic patients with COPD will be recruited in China for comparison of low dose theophylline versus placebo and low dose theophylline + low dose prednisone The primary end-point for this study is the annualised COPD exacerbation rate between the treatment groups. Secondary outcomes included time to first severe exacerbation requiring hospitalisation or death, health status, and pre- and post-bronchodilator spirometry.
Read the detailed description
The investigators hypothesise that patients with COPD will have beneficial responses to low dose theophylline and prednisone, superior to placebo and low dose theophylline alone, reflected by a range of clinical outcomes.
The study aims to demonstrate that treatment with low dose oral prednisone and low dose, slow release theophylline compared to low dose, slow release theophylline only or placebo will reduce COPD exacerbations and improve a range of secondary outcomes including quality of life, COPD Assessment Test (CAT) score, hospital admissions and lung function.
Eligible participants will be randomised to one of three treatment arms in a DBRCT and will receive placebo OR low-dose theophylline (100 mg twice a day) OR low-dose theophylline 100 mg twice a day (BD) plus low-dose prednisone (5 mg once a day)
Patients will be eligible for inclusion if all the following criteria are met:
- Current or former smokers (>10 pack years) or biomass exposure
- 40 - 80 years of age
- Clinical diagnosis of COPD
- Post-bronchodilator forced expiratory volume at one second (FEV1) <70% predicted
- Post bronchodilator FEV1/forced vital capacity (FVC) ratio<0.7
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Theophylline, Prednisone, Placebo (for prednisone), Placebo (for Theophylline)
- Keywords
- COPD, Theophylline, Oral corticosteroids, COPD exacerbations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheophyllineDrug
Also called Theophylline (100 mg twice a day)
Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor
PrednisoneDrug
Also called Prednisone (5mg once daily), cortisone
Prednisone is an oral glucocorticosteroid which has anti-inflammatory properties
Placebo (for prednisone)Drug
Also called Prednisone placebo 1 tab once daily in arms 1 and 2
- Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily
- Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily
Placebo (for Theophylline)Drug
Also called Theophylline placebo 1 tab twice daily
One tablet twice daily in arm 1 (theophylline placebo 1 BD + prednisone placebo 1 once daily)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo theophylline, one tablet twice daily, and Placebo prednisone, one tablet once daily Receives: Drug: Placebo (for prednisone); Drug: Placebo (for Theophylline) |
| Low-dose theophylline arm | Active comparator | Theophylline 100 mg twice daily Receives: Drug: Theophylline; Drug: Placebo (for prednisone) |
| Theophylline and Prednisone arm | Active comparator | Theophylline 100 mg twice daily plus prednisone 5 mg once daily Receives: Drug: Theophylline; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total COPD Exacerbation Rate
The total number of COPD exacerbations reported within 48 weeks
Measured: 48 weeks observation; rate annualised
Secondary outcomes (4)
Time to First COPD Exacerbation
The median time (days) from randomisation to first exacerbation per participant
Measured: Median time (days) from randomisation to first exacerbation over a 48 week period per participant
Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)
THe St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Change over 48 week study duration
Post Bronchodilator FEV1
The change in post bronchodilator FEV1 from baseline to 48 weeks
Measured: Change at 48 weeks
Change in COPD Assessment Test (CAT) Score
The COPD Assessment Test (CAT) is a patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dysnea, chest tighteness) on health status. The range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. The outcome measure is assessing the change in score from baseline to 48 weeks. A negative change denotes an improvement in health status.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startJun 2014
- Primary completion14 May 2018
- Study completion14 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,670 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
- Investigators
- Norbert Berend, MD, Principal investigator, The George InstituteChristine R Jenkins, MD, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261727
- Sponsor's protocol ID
- TGI-Resp-01
- Other IDs
- 1033117
- Acronym
- TASCS
- Status last verified
- Aug 2021
- First submitted
- 7 May 2014
- Last updated
- 12 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jenkins CR, Wen FQ, Martin A, Barnes PJ, Celli B, Zhong NS, Zheng JP, Scaria A, Di Tanna GL, Bradbury T, Berend N; TASCS study investigators. The effect of low-dose corticosteroids and theophylline on the risk of acute exacerbations of COPD: the TASCS randomised controlled trial. Eur Respir J. 2021 Jun 10;57(6):2003338. doi: 10.1183/13993003.03338-2020. Print 2021 Jun.
PubMed 33334939
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-dose Corticosteroids and Theophylline on the Risk of Acute Exacerbations of COPD: the TASCS Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02261727
- Acronym / sponsor ID
- TASCS / TGI-Resp-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Theophylline, Oral corticosteroids, COPD exacerbations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,670 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Jun 2014 (actual)
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Posted 12 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this multi-centre, double blind, randomised, controlled trial (DBRCT) is to assess the effect of low dose theophylline, singly and in combination with low dose oral prednisone, on COPD (Chronic Obstructive Pulmonary Disease) exacerbations, quality of life and secondary clinical outcomes compared with usual therapy and placebo over 48 weeks of treatment. 1670 symptomatic patients with COPD will be recruited in China for comparison of low dose theophylline versus placebo and low dose theophylline + low dose prednisone The primary end-point for this study is the annualised COPD exacerbation rate between the treatment groups. Secondary outcomes included time to first severe exacerbation requiring hospitalisation or death, health status, and pre- and post-bronchodilator spirometry.
Detailed description
The investigators hypothesise that patients with COPD will have beneficial responses to low dose theophylline and prednisone, superior to placebo and low dose theophylline alone, reflected by a range of clinical outcomes.
The study aims to demonstrate that treatment with low dose oral prednisone and low dose, slow release theophylline compared to low dose, slow release theophylline only or placebo will reduce COPD exacerbations and improve a range of secondary outcomes including quality of life, COPD Assessment Test (CAT) score, hospital admissions and lung function.
Eligible participants will be randomised to one of three treatment arms in a DBRCT and will receive placebo OR low-dose theophylline (100 mg twice a day) OR low-dose theophylline 100 mg twice a day (BD) plus low-dose prednisone (5 mg once a day)
Patients will be eligible for inclusion if all the following criteria are met:
- Current or former smokers (>10 pack years) or biomass exposure
- 40 - 80 years of age
- Clinical diagnosis of COPD
- Post-bronchodilator forced expiratory volume at one second (FEV1) <70% predicted
- Post bronchodilator FEV1/forced vital capacity (FVC) ratio<0.7
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo (for prednisone), Drug: Placebo (for Theophylline)Placebo theophylline, one tablet twice daily, and Placebo prednisone, one tablet once daily |
| Low-dose theophylline arm | Active comparator | Drug: Theophylline, Drug: Placebo (for prednisone)Theophylline 100 mg twice daily |
| Theophylline and Prednisone arm | Active comparator | Drug: Theophylline, Drug: PrednisoneTheophylline 100 mg twice daily plus prednisone 5 mg once daily |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current or former smokers (> 10 pack years) or biomass exposure
- 40 - 80 years of age
- Clinical diagnosis of COPD
- Post-bronchodilator FEV1 < 70% predicted
- Post bronchodilator FEV1/FVC ratio < 0.7
Key exclusion criteria (12 listed)
- Life expectancy of less than 12 months
- Exacerbation or respiratory infection within 4 weeks prior to randomisation
- Patient is taking and requires maintenance oral corticosteroids
- Patient is on domiciliary oxygen
- There has been previous pulmonary resection
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 (100 mg twice a day)Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor | Drug | Low-dose theophylline arm, Theophylline and Prednisone arm |
| PrednisoneAlso: Prednisone (5mg once daily), cortisonePrednisone is an oral glucocorticosteroid which has anti-inflammatory properties | Drug | Theophylline and Prednisone arm |
| Placebo (for prednisone)Also: Prednisone placebo 1 tab once daily in arms 1 and 2* Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily * Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily | Drug | Low-dose theophylline arm, Placebo |
| Placebo (for Theophylline)Also: Theophylline placebo 1 tab twice dailyOne tablet twice daily in arm 1 (theophylline placebo 1 BD + prednisone placebo 1 once daily) | Drug | Placebo |
Primary outcome
Total COPD Exacerbation Rate
Time frame: 48 weeks observation; rate annualised
The total number of COPD exacerbations reported within 48 weeks
4 secondary outcomes
Time to First COPD Exacerbation
Time frame: Median time (days) from randomisation to first exacerbation over a 48 week period per participant
Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)
Time frame: Change over 48 week study duration
Post Bronchodilator FEV1
Time frame: Change at 48 weeks
Change in COPD Assessment Test (CAT) Score
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33334939Jenkins CR, Wen FQ, Martin A, Barnes PJ, Celli B, Zhong NS, Zheng JP, Scaria A, Di Tanna GL, Bradbury T, Berend N; TASCS study investigators. The effect of low-dose corticosteroids and theophylline on the risk of acute exacerbations of COPD: the TASCS randomised controlled trial. Eur Respir J. 2021 Jun 10;57(6):2003338. doi: 10.1183/13993003.03338-2020. Print 2021 Jun.
- Individual participant dataSharing planned: No
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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.
Norbert Berend, MD principal investigator
The George Institute
Christine R Jenkins, MD principal investigator
The George Institute
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 and Prednisone in people with Chronic Obstructive Pulmonary Disease, run by The George Institute at 1 site in Australia.
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 5 inclusion and 12 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 12 Aug 2021. 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 Australia. 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?
Yes. Results are posted in the registry (first posted 12 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total COPD Exacerbation Rate (time frame: 48 weeks observation; rate annualised). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02261727, which also lists 1 linked publication.
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 12 Aug 2021.