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Trial · NCT02261727

Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study

NCT02261727, Phase 4, Completed, The George Institute; results first posted 2021-08-12

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study. Trials, record NCT02261727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02261727

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study
NCT number
NCT02261727
Status
Completed
Phases
Phase 4
Enrollment
1,670 participants, actual
Lead sponsor
The George Institute
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
Theophylline, Prednisone, Placebo (for prednisone), Placebo (for Theophylline)
First posted
2014-10-10
Last updated
2021-08-12
Results first posted
2021-08-12
Limitations and caveats
There are some limitations to our study, there was a 26% withdrawal rate in this study, with a higher rate of withdrawals occurring earlier in the trial. Patients requested withdrawal if they felt the treatment was not helping them and, in particular, if they suffered an exacerbation. This was most evident at the first study visit after treatment commencement, when the greatest number of withdrawals occurred.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTotal COPD Exacerbation Rate48 weeks observation; rate annualisedThe total number of COPD exacerbations reported within 48 weeks
SecondaryTime to First COPD ExacerbationMedian time (days) from randomisation to first exacerbation over a 48 week period per participantThe median time (days) from randomisation to first exacerbation per participant
SecondaryQuality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)Change over 48 week study duration
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.
SecondaryPost Bronchodilator FEV1Change at 48 weeksThe change in post bronchodilator FEV1 from baseline to 48 weeks
SecondaryChange in COPD Assessment Test (CAT) Score48 weeks
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.
OtherHospitalisations48 weeksThe total number of hospitalisation events within 48 weeks

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYTotal COPD Exacerbation Rate48 weeks observation; rate annualisedExacerbations per participant yearNUMBER
SECONDARYTime to First COPD ExacerbationMedian time (days) from randomisation to first exacerbation over a 48 week period per participantDaysMEDIAN
SECONDARYQuality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)Change over 48 week study durationScores on a scaleMEAN
SECONDARYPost Bronchodilator FEV1Change at 48 weeksL/secMEAN
SECONDARYChange in COPD Assessment Test (CAT) Score48 weeksScore on a scaleMEAN
OTHER_PRE_SPECIFIEDHospitalisations48 weeksNumber of hospitalisation eventsNUMBER

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Total COPD Exacerbation RatePlacebo1.0095% Confidence Interval 0.87 to 1.14Exacerbations per participant year
Total COPD Exacerbation RateLow-dose Theophylline Arm0.8695% Confidence Interval 0.75 to 0.99Exacerbations per participant year
Total COPD Exacerbation RateTheophylline and Prednisone Arm0.8995% Confidence Interval 0.78 to 1.02Exacerbations per participant year
Time to First COPD ExacerbationPlacebo137Inter-Quartile Range 58.5 to 233.5Days
Time to First COPD ExacerbationLow-dose Theophylline Arm150Inter-Quartile Range 66.0 to 242.0Days
Time to First COPD ExacerbationTheophylline and Prednisone Arm151Inter-Quartile Range 71.0 to 247.0Days
Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)Placebo-4.95Standard Deviation 0.91Scores on a scale
Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)Low-dose Theophylline Arm-6.85Standard Deviation 0.91Scores on a scale
Quality of Life Measured by St. George's Respiratory Questionnaire (SGRQ)Theophylline and Prednisone Arm-6.48Standard Deviation 0.89Scores on a scale
Post Bronchodilator FEV1Placebo-0.02Standard Deviation 0.01L/sec

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDLow-dose Theophylline Arm568
Overall StudySTARTEDPlacebo554
Overall StudySTARTEDTheophylline and Prednisone Arm548
Overall StudyCOMPLETEDLow-dose Theophylline Arm411
Overall StudyCOMPLETEDPlacebo408
Overall StudyCOMPLETEDTheophylline and Prednisone Arm423
Overall StudyNOT COMPLETEDLow-dose Theophylline Arm157
Overall StudyNOT COMPLETEDPlacebo146
Overall StudyNOT COMPLETEDTheophylline and Prednisone Arm125

Source ClinicalTrials.gov

Adverse events9

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherCOPD Exacerbation - not hospitalisedRespiratory, thoracic and mediastinal disordersPlacebo168554306
otherCOPD Exacerbation - not hospitalisedRespiratory, thoracic and mediastinal disordersLow-dose Theophylline Arm181568290
otherCOPD Exacerbation - not hospitalisedRespiratory, thoracic and mediastinal disordersTheophylline and Prednisone Arm173548306
otherUpper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disordersPlacebo2855437
otherUpper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disordersLow-dose Theophylline Arm4156854
otherUpper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disordersTheophylline and Prednisone Arm2954834
seriousCOPD Exacerbation - HospitalisedRespiratory, thoracic and mediastinal disordersPlacebo96554135
seriousCOPD Exacerbation - HospitalisedRespiratory, thoracic and mediastinal disordersLow-dose Theophylline Arm91568102
seriousCOPD Exacerbation - HospitalisedRespiratory, thoracic and mediastinal disordersTheophylline and Prednisone Arm83548115

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPlacebo3554
Total, all-cause mortalityLow-dose Theophylline Arm2568
Total, all-cause mortalityTheophylline and Prednisone Arm2548
Total, other adverse eventsPlacebo196554
Total, other adverse eventsLow-dose Theophylline Arm222568
Total, other adverse eventsTheophylline and Prednisone Arm202548
Total, serious adverse eventsPlacebo96554
Total, serious adverse eventsLow-dose Theophylline Arm91568
Total, serious adverse eventsTheophylline and Prednisone Arm83548

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
33334939DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02261727

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