Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL146946-01 | U.S. NIH Grant/Contract | View source | |
| IRB00209008 | Other Identifier | Johns Hopkins University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide, and over 90% of COPD-related deaths occurring in low- and middle-income countries (LMICs). Household air pollution (HAP) - from burning solid fuels such as wood, dung, agricultural crop waste, and coal for energy - is the primary risk factor for COPD in these settings. Biomass-related COPD has a distinct histopathology, phenotype and inflammatory profile when compared to tobacco mediated COPD. Despite the high global burden of biomass-related disease, little is known about the effectiveness of pharmacotherapies for biomass-related COPD; to date, no clinical trials have focused specifically on treatment of biomass-related COPD. This study proposes to assess the health impact of biomass-related COPD and test the effectiveness of low dose theophylline compared to standard therapy among adults with biomass-related COPD in Uganda with the aim to assess whether low-dose theophylline improves respiratory symptoms, decreases the inflammatory profile of serum biomarkers and whether administration attenuates the effect of HAP on lung function. The study additionally aims to assess whether low-dose theophylline is a cost-effective intervention based on the incremental cost-effectiveness ratio and a range of willingness to pay thresholds.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose Theophylline Group | Experimental | Participant in this group will receive low-dose theophylline in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment, over a one year period. |
|
| Placebo Group | Placebo Comparator | Participant in this group will receive a placebo in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theophylline ER | Drug | 200 mg extended release (ER) low-dose theophylline taken orally daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in St. George Respiratory Questionnaire (SGRQ) Scores | 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. | Baseline, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Expiratory Volume in One Second (FEV1) | 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. | Baseline, 1 year |
| Change in Forced Vital Capacity (FVC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Trishul Siddharthan, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makerere Lung Institute | Kampala | Uganda | ||||
| Nakaseke Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23674502 | Background | Bonjour S, Adair-Rohani H, Wolf J, Bruce NG, Mehta S, Pruss-Ustun A, Lahiff M, Rehfuess EA, Mishra V, Smith KR. Solid fuel use for household cooking: country and regional estimates for 1980-2010. Environ Health Perspect. 2013 Jul;121(7):784-90. doi: 10.1289/ehp.1205987. Epub 2013 May 3. | |
| 29323928 | Background | Siddharthan T, Grigsby MR, Goodman D, Chowdhury M, Rubinstein A, Irazola V, Gutierrez L, Miranda JJ, Bernabe-Ortiz A, Alam D, Kirenga B, Jones R, van Gemert F, Wise RA, Checkley W. Association between Household Air Pollution Exposure and Chronic Obstructive Pulmonary Disease Outcomes in 13 Low- and Middle-Income Country Settings. Am J Respir Crit Care Med. 2018 Mar 1;197(5):611-620. doi: 10.1164/rccm.201709-1861OC. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There is a discrepancy between the protocol section enrollment number vs the participants that started in the participant flow due to one participant decided not to proceed in the study after they consented and were enrolled but left the study just prior to randomization and therefore did not proceed in the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Low-dose Theophylline Group | Participant in this group will receive low-dose theophylline in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment, over a one year period. Theophylline ER: 200 mg extended release (ER) low-dose theophylline taken orally daily Standard of Care Treatment: Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 22, 2020 | Oct 3, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo oral tablet | Drug | Manufactured methylcellulose placebo tablet taken orally daily |
|
| Standard of Care Treatment | Other | Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment |
|
FVC measures how much air a person can exhale at the end of a forced breath measured in liters. |
| Baseline, 1 year |
| Change in Forced Vital Capacity (FVC) | FVC measures how much air a person can exhale at the end of a forced breath measured in liters. | Baseline, 6 months |
| Change in St. George Respiratory Questionnaire (SGRQ) Scores | 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. | Baseline, 6 months |
| Change in Forced Expiratory Volume in One Second (FEV1) | 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. | Baseline, 6 months |
| Nakaseke |
| Uganda |
| 18713510 | Background | Moran-Mendoza O, Perez-Padilla JR, Salazar-Flores M, Vazquez-Alfaro F. Wood smoke-associated lung disease: a clinical, functional, radiological and pathological description. Int J Tuberc Lung Dis. 2008 Sep;12(9):1092-8. |
| 28848808 | Background | Perez-Padilla R, Ramirez-Venegas A, Sansores-Martinez R. Clinical Characteristics of Patients With Biomass Smoke-Associated COPD and Chronic Bronchitis, 2004-2014. Chronic Obstr Pulm Dis. 2014 May 6;1(1):23-32. doi: 10.15326/jcopdf.1.1.2013.0004. |
| 11693980 | Background | Ait-Khaled N, Enarson D, Bousquet J. Chronic respiratory diseases in developing countries: the burden and strategies for prevention and management. Bull World Health Organ. 2001;79(10):971-9. Epub 2001 Nov 1. |
| 25680912 | Background | Beran D, Zar HJ, Perrin C, Menezes AM, Burney P; Forum of International Respiratory Societies working group collaboration. Burden of asthma and chronic obstructive pulmonary disease and access to essential medicines in low-income and middle-income countries. Lancet Respir Med. 2015 Feb;3(2):159-170. doi: 10.1016/S2213-2600(15)00004-1. |
| 16267358 | Background | Barnes PJ. Theophylline in chronic obstructive pulmonary disease: new horizons. Proc Am Thorac Soc. 2005;2(4):334-9; discussion 340-1. doi: 10.1513/pats.200504-024SR. |
| 20299628 | Background | Ford PA, Durham AL, Russell RE, Gordon F, Adcock IM, Barnes PJ. Treatment effects of low-dose theophylline combined with an inhaled corticosteroid in COPD. Chest. 2010 Jun;137(6):1338-44. doi: 10.1378/chest.09-2363. Epub 2010 Mar 18. |
| 18647460 | Background | Rivera RM, Cosio MG, Ghezzo H, Salazar M, Perez-Padilla R. Comparison of lung morphology in COPD secondary to cigarette and biomass smoke. Int J Tuberc Lung Dis. 2008 Aug;12(8):972-7. |
| 17546309 | Background | Mendis S, Fukino K, Cameron A, Laing R, Filipe A Jr, Khatib O, Leowski J, Ewen M. The availability and affordability of selected essential medicines for chronic diseases in six low- and middle-income countries. Bull World Health Organ. 2007 Apr;85(4):279-88. doi: 10.2471/blt.06.033647. |
| 16916334 | Background | Zhou Y, Wang X, Zeng X, Qiu R, Xie J, Liu S, Zheng J, Zhong N, Ran P. Positive benefits of theophylline in a randomized, double-blind, parallel-group, placebo-controlled study of low-dose, slow-release theophylline in the treatment of COPD for 1 year. Respirology. 2006 Sep;11(5):603-10. doi: 10.1111/j.1440-1843.2006.00897.x. |
| 33726828 | Derived | Siddharthan T, Pollard SL, Jackson P, Robertson NM, Wosu AC, Rahman N, Padalkar R, Sekitoleko I, Namazzi E, Alupo P, Hurst JR, Kalyesubula R, Dowdy D, Wise R, Barnes PJ, Checkley W, Kirenga B. Effectiveness of low-dose theophylline for the management of biomass-associated COPD (LODOT-BCOPD): study protocol for a randomized controlled trial. Trials. 2021 Mar 16;22(1):213. doi: 10.1186/s13063-021-05163-2. |
| FG001 | Placebo Group | Participant in this group will receive a placebo in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment. Placebo oral tablet: Manufactured methylcellulose placebo tablet taken orally daily Standard of Care Treatment: Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment |
| 6 Months |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Low-dose Theophylline Group | Participant in this group will receive low-dose theophylline in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment, over a one year period. Theophylline ER: 200 mg extended release (ER) low-dose theophylline taken orally daily Standard of Care Treatment: Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment |
| BG001 | Placebo Group | Participant in this group will receive a placebo in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment. Placebo oral tablet: Manufactured methylcellulose placebo tablet taken orally daily Standard of Care Treatment: Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in St. George Respiratory Questionnaire (SGRQ) Scores | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 year |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Forced Expiratory Volume in One Second (FEV1) | 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. | Posted | Mean | Standard Deviation | Liters | Baseline, 1 year |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Forced Vital Capacity (FVC) | FVC measures how much air a person can exhale at the end of a forced breath measured in liters. | Posted | Mean | Standard Deviation | Liters | Baseline, 1 year |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Forced Vital Capacity (FVC) | FVC measures how much air a person can exhale at the end of a forced breath measured in liters. | Posted | Mean | Standard Deviation | Liters | Baseline, 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in St. George Respiratory Questionnaire (SGRQ) Scores | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months |
| |||||||||||||||||||||||||||||||
| Secondary | Change in Forced Expiratory Volume in One Second (FEV1) | 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. | Posted | Mean | Standard Deviation | Liters | Baseline, 6 months |
|
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-dose Theophylline Group | Participant in this group will receive low-dose theophylline in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment, over a one year period. Theophylline ER: 200 mg extended release (ER) low-dose theophylline taken orally daily Standard of Care Treatment: Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment | 2 | 50 | 5 | 50 | 26 | 50 |
| EG001 | Placebo Group | Participant in this group will receive a placebo in addition to standard care, per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment. Placebo oral tablet: Manufactured methylcellulose placebo tablet taken orally daily Standard of Care Treatment: Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment | 4 | 49 | 3 | 49 | 19 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hospitalization for Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Hospitalization for anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hospitalization for failure to thrive | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Arthalgia/Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Change in urinary frequency | Renal and urinary disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trishul Siddharthan | University of Miami | 305-243-6388 | tsiddhar@miami.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2023 | Oct 3, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2021 | Oct 3, 2024 | ICF_002.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013806 | Theophylline |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|