Trial · NCT03984188
Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD
NCT03984188, Phase 3, Completed, University of Miami; results first posted 2024-10-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD. Trials, record NCT03984188. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03984188
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD
- NCT number
- NCT03984188
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 100 participants, actual
- Lead sponsor
- University of Miami
- Conditions
- COPD, COPD Exacerbation, COPD Exacerbation Acute, Pollution Related Respiratory Disorder, Pollution; Exposure
- Interventions
- Theophylline ER, Placebo oral tablet, Standard of Care Treatment
- First posted
- 2019-06-12
- Last updated
- 2024-11-15
- Results first posted
- 2024-10-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in St. George Respiratory Questionnaire (SGRQ) Scores | Baseline, 1 year | The SGRQ comprises of 50 items and consists of two parts. The first part pertains to symptoms and the second pertains to functional status as well as social and psychological impact of disease. Overall scores ranges between 0 and 100 with higher scores indicating more limitations. |
| Secondary | Change in Forced Expiratory Volume in One Second (FEV1) | Baseline, 1 year | FEV1 measures how much air a person can exhale during a forced breath. The amount of air exhaled during the first second measured in liters. |
| Secondary | Change in Forced Vital Capacity (FVC) | Baseline, 1 year | FVC measures how much air a person can exhale at the end of a forced breath measured in liters. |
| Secondary | Change in Forced Vital Capacity (FVC) | Baseline, 6 months | FVC measures how much air a person can exhale at the end of a forced breath measured in liters. |
| Secondary | Change in St. George Respiratory Questionnaire (SGRQ) Scores | Baseline, 6 months | The SGRQ comprises of 50 items and consists of two parts. The first part pertains to symptoms and the second pertains to functional status as well as social and psychological impact of disease. Overall scores ranges between 0 and 100 with higher scores indicating more limitations. |
| Secondary | Change in Forced Expiratory Volume in One Second (FEV1) | Baseline, 6 months | FEV1 measures how much air a person can exhale during a forced breath. The amount of air exhaled during the first second measured in liters. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in St. George Respiratory Questionnaire (SGRQ) Scores | Baseline, 1 year | score on a scale | MEAN | |
| SECONDARY | Change in Forced Expiratory Volume in One Second (FEV1) | Baseline, 1 year | Liters | MEAN | |
| SECONDARY | Change in Forced Vital Capacity (FVC) | Baseline, 1 year | Liters | MEAN | |
| SECONDARY | Change in Forced Vital Capacity (FVC) | Baseline, 6 months | Liters | MEAN | |
| SECONDARY | Change in St. George Respiratory Questionnaire (SGRQ) Scores | Baseline, 6 months | score on a scale | MEAN | |
| SECONDARY | Change in Forced Expiratory Volume in One Second (FEV1) | Baseline, 6 months | Liters | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in St. George Respiratory Questionnaire (SGRQ) Scores | Low-dose Theophylline Group | 39.02 | Standard Deviation 21.00 | score on a scale | |
| Change in St. George Respiratory Questionnaire (SGRQ) Scores | Placebo Group | 45.06 | Standard Deviation 16.87 | score on a scale | |
| Change in Forced Expiratory Volume in One Second (FEV1) | Low-dose Theophylline Group | 1.40 | Standard Deviation 0.51 | Liters | |
| Change in Forced Expiratory Volume in One Second (FEV1) | Placebo Group | 1.45 | Standard Deviation 0.58 | Liters | |
| Change in Forced Vital Capacity (FVC) | Low-dose Theophylline Group | 2.47 | Standard Deviation 0.68 | Liters | |
| Change in Forced Vital Capacity (FVC) | Placebo Group | 2.58 | Standard Deviation 0.81 | Liters | |
| Change in Forced Vital Capacity (FVC) | Low-dose Theophylline Group | 2.51 | Standard Deviation 0.68 | Liters | |
| Change in Forced Vital Capacity (FVC) | Placebo Group | 2.52 | Standard Deviation 0.84 | Liters | |
| Change in St. George Respiratory Questionnaire (SGRQ) Scores | Low-dose Theophylline Group | 37.86 | Standard Deviation 21.37 | score on a scale | |
| Change in St. George Respiratory Questionnaire (SGRQ) Scores | Placebo Group | 44.45 | Standard Deviation 19.48 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low-dose Theophylline Group | 50 | |
| Overall Study | STARTED | Placebo Group | 49 | |
| Overall Study | 6 Months | Low-dose Theophylline Group | 42 | |
| Overall Study | 6 Months | Placebo Group | 47 | |
| Overall Study | COMPLETED | Low-dose Theophylline Group | 39 | |
| Overall Study | COMPLETED | Placebo Group | 41 | |
| Overall Study | NOT COMPLETED | Low-dose Theophylline Group | 11 | |
| Overall Study | NOT COMPLETED | Placebo Group | 8 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Low-dose Theophylline Group | 14 | 50 | |
| other | COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Placebo Group | 10 | 49 | |
| other | Arthalgia/Myalgia | Musculoskeletal and connective tissue disorders | Low-dose Theophylline Group | 3 | 50 | |
| other | Arthalgia/Myalgia | Musculoskeletal and connective tissue disorders | Placebo Group | 5 | 49 | |
| other | Change in urinary frequency | Renal and urinary disorders | Low-dose Theophylline Group | 2 | 50 | |
| other | Change in urinary frequency | Renal and urinary disorders | Placebo Group | 0 | 49 | |
| other | Gastritis | Gastrointestinal disorders | Low-dose Theophylline Group | 7 | 50 | |
| other | Gastritis | Gastrointestinal disorders | Placebo Group | 4 | 49 | |
| other | Insomnia | Psychiatric disorders | Low-dose Theophylline Group | 0 | 50 | |
| other | Insomnia | Psychiatric disorders | Placebo Group | 1 | 49 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low-dose Theophylline Group | 2 | 50 |
| Total, all-cause mortality | Placebo Group | 4 | 49 |
| Total, other adverse events | Low-dose Theophylline Group | 26 | 50 |
| Total, other adverse events | Placebo Group | 19 | 49 |
| Total, serious adverse events | Low-dose Theophylline Group | 5 | 50 |
| Total, serious adverse events | Placebo Group | 3 | 49 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K23HL146946 | Effectiveness of Low-dose Theophylline for the Management of biomass-associated COPD | SIDDHARTHAN, TRISHUL | UNIVERSITY OF MIAMI SCHOOL OF MEDICINE | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2019 to 2023 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Low-dose Theophylline Group vs Placebo Group: deaths from any cause | Trial comparisons |
| Low-dose Theophylline Group vs Placebo Group: serious adverse events | Trial comparisons |
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03984188
GET https://conductscience.org/api/trials/v1/NCT03984188/registered