Effectiveness of Low-dose Theophylline for the Management of Biomass-associated COPD in Uganda
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03984188|
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|COPD COPD Exacerbation COPD Exacerbation Acute Pollution Related Respiratory Disorder Pollution; Exposure||Drug: Theophylline ER Drug: Placebo oral tablet||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effectiveness of Low-dose Theophylline for the Management of Biomass-associated COPD|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2022|
Experimental: Low-dose Theophylline
Participant in this group will receive low-dose theophylline.
Drug: Theophylline ER
250mg ER low-dose theophylline taken orally daily
Other Name: Low-dose Theophylline
Placebo Comparator: Placebo
Participant in this group will receive a placebo.
Drug: Placebo oral tablet
Manufactured placebo tablet taken orally daily
- Change in St. George Respiratory Questionnaire score (SGRQ) [ Time Frame: Baseline, 6 months, 1 year ]The St. George Respiratory Questionnaire score 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.
- Cost-Effectiveness as assessed by the Short Form 36 (SF-36) [ Time Frame: 1 year ]Incremental cost-effectiveness using the Short From 36 score comprising 36 items. The SF-36 consists of eight scaled domains (vitality, physical functioning, body pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) each transformed into a 0-100 scale. Lower scores signify higher levels of disability.
- Change in forced expiratory volume in one second (FEV1) [ Time Frame: Baseline, 6 months, 1 year ]FEV1 (L) as measured through spirometry
- Change in forced vital capacity (FVC) [ Time Frame: Baseline, 6 months, 1 year ]FVC (L) as measured through spirometry
- Change in peak expiratory flow (PEF) [ Time Frame: Baseline, 6 months, 1 year ]PEF (L/min) as measured through spirometry
- Change in blood levels of high sensitivity C reactive protein (hs-CRP) [ Time Frame: Baseline, 6 months, 1 year ]Blood levels of hs-CRP (mg/L)
- Change in blood levels of fibrinogen [ Time Frame: Baseline, 6 months, 1 year ]Blood levels of fibrinogen (mg/dL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984188
|Contact: Trishul Siddharthan, MD||(410) email@example.com|
|Contact: Phabiola Herrera, MDfirstname.lastname@example.org|
|Principal Investigator:||William Checkley||Johns Hopkins University|