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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02261727




Registration number
NCT02261727
Ethics application status
Date submitted
7/05/2014
Date registered
10/10/2014
Date last updated
27/06/2018

Titles & IDs
Public title
Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study
Scientific title
Low Dose Corticosteroids and Theophylline in the Treatment of Chronic Obstructive Pulmonary Disease - the TASCS Study
Secondary ID [1] 0 0
1033117
Secondary ID [2] 0 0
TGI-Resp-01
Universal Trial Number (UTN)
Trial acronym
TASCS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Theophylline
Treatment: Drugs - Prednisone
Treatment: Drugs - Placebo (for prednisone)
Treatment: Drugs - Placebo (for Theophylline)

Placebo Comparator: Placebo - Placebo theophylline, one tablet twice daily, and Placebo prednisone, one tablet once daily

Active Comparator: Low-dose theophylline arm - Theophylline 100 mg twice daily

Active Comparator: Theophylline and Prednisone arm - Theophylline 100 mg twice daily plus prednisone 5 mg once daily


Treatment: Drugs: Theophylline
Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor

Treatment: Drugs: Prednisone
Prednisone is an oral glucocorticosteroid which has anti-inflammatory properties

Treatment: Drugs: Placebo (for prednisone)
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

Treatment: Drugs: Placebo (for Theophylline)
One tablet twice daily in arm 1 (theophylline placebo 1 BD + prednisone placebo 1 once daily)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
COPD exacerbation rate
Timepoint [1] 0 0
48 weeks observation; rate annualised
Secondary outcome [1] 0 0
Time to first COPD exacerbation - Assessed at weeks 12, 24,36 and 48 using patient diary
Timepoint [1] 0 0
Time (days) from randomisation to first exacerbationAssessed at weeks 12, 24,36 and 48 using patient diary
Secondary outcome [2] 0 0
Quality of life measured by St. George's Respiratory Questionnaire (SGRQ)
Timepoint [2] 0 0
Change over 48 week study duration
Secondary outcome [3] 0 0
Pre and post bronchodilator FEV1
Timepoint [3] 0 0
Change at 12 week visits and 48 weeks
Secondary outcome [4] 0 0
Change in CAT score - COPD Assessment Test
Timepoint [4] 0 0
12, 24, 36 48 weeks

Eligibility
Key inclusion criteria
- 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
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The George Institute for Global Health - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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 therapy and placebo over 48 weeks of treatment.
Approximately 2400 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 difference between the three treatment groups in

- COPD exacerbation rate

- Time to first severe exacerbation requiring hospitalisation or death
Trial website
https://clinicaltrials.gov/show/NCT02261727
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Norbert Berend, MD
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications