COPDPhase 3NCT03984188

Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD

A Phase 3 study testing Theophylline ER in people with COPD and COPD Exacerbation, run by University of Miami at 2 sites in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD, COPD Exacerbation, COPD Exacerbation Acute
What is being tested?: Theophylline ER
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 2 sitesUganda
Study dates: 23 Feb 2021to 15 Dec 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 40 years
Full-time resident of study area
Post-bronchodilator FEV1/FVC < the lower limit of normal of the Global Lung Initiative Mixed Ethnic reference population
Grade B-D COPD
Daily biomass exposure

Who cannot join

Plans to move within one year
Uncontrolled hypertension
Pregnancy (assessed by urine pregnancy test among women of childbearing age/menstrual history)
Current use of chronic respiratory medications (Long acting Beta 2 Antagonists (LABA), Long-acting muscarinic antagonist (LAMA), inhaled corticosteroid (ICS))
History of post-treatment pulmonary tuberculosis
≥10 pack year tobacco smoking history
Known intolerance or contraindication to theophylline.

Trial locations and contacts

2 sites in 1 country.

Uganda2 sites

Makerere Lung Institute
Kampala
Nakaseke Hospital
Nakaseke

Other trials in Uganda

About this study

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.

Conditions: COPD, COPD Exacerbation, COPD Exacerbation Acute, Pollution Related Respiratory Disorder, Pollution; Exposure
Being tested: Theophylline ER, Placebo oral tablet, Standard of Care Treatment
Keywords: Biomass Associated COPD, Low-dose Theophylline
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Theophylline ERDrug
Also called Low-dose Theophylline
200 mg extended release (ER) low-dose theophylline taken orally daily
Placebo oral tabletDrug
Manufactured methylcellulose placebo tablet taken orally daily
Standard of Care TreatmentOther
Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment

Study groups in NCT03984188
Study group	Role	What they receive
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. Receives: Drug: Theophylline ER; Other: Standard of Care Treatment
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. Receives: Drug: Placebo oral tablet; Other: Standard of Care Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 1 year

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 202115 Dec 2023

First posted12 Jun 2019
Study start23 Feb 2021
Primary completion17 Oct 2023
Study completion15 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03984188
Sponsor's protocol ID: 20201523
Other IDs: 1K23HL146946-01, IRB00209008
Status last verified: Oct 2024
First submitted: 10 Jun 2019
Last updated: 15 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 23674502
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.
PubMed 29323928
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.
PubMed 18713510
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.
PubMed 28848808
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.
PubMed 11693980
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.
PubMed 25680912
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.
PubMed 16267358
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.
PubMed 20299628
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.
PubMed 18647460
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.
PubMed 17546309
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.
PubMed 16916334
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.
PubMed 33726828

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD
ClinicalTrials.gov ID: NCT03984188
Acronym / sponsor ID: 20201523
Conditions: COPD, COPD Exacerbation, COPD Exacerbation Acute, Pollution Related Respiratory Disorder, Pollution; Exposure
Keywords: Biomass Associated COPD, Low-dose Theophylline
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 23 Feb 2021 (actual)
Primary completion: 17 Oct 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 12 Jun 2019 (actual)
Results: Posted 29 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Low-dose Theophylline Group	Experimental	Drug: Theophylline ER, Other: Standard of Care TreatmentParticipant 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	Drug: Placebo oral tablet, Other: Standard of Care TreatmentParticipant 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.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥ 40 years
Full-time resident of study area
Post-bronchodilator FEV1/FVC < the lower limit of normal of the Global Lung Initiative Mixed Ethnic reference population
Grade B-D COPD
Daily biomass exposure

Key exclusion criteria (7 listed)

Plans to move within one year
Uncontrolled hypertension
Pregnancy (assessed by urine pregnancy test among women of childbearing age/menstrual history)
Current use of chronic respiratory medications (Long acting Beta 2 Antagonists (LABA), Long-acting muscarinic antagonist (LAMA), inhaled corticosteroid (ICS))
History of post-treatment pulmonary tuberculosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Theophylline ERAlso: Low-dose Theophylline200 mg extended release (ER) low-dose theophylline taken orally daily	Drug	Low-dose Theophylline Group
Placebo oral tabletManufactured methylcellulose placebo tablet taken orally daily	Drug	Placebo Group
Standard of Care TreatmentPer World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment	Other	Low-dose Theophylline Group, Placebo Group

Primary outcome

Change in St. George Respiratory Questionnaire (SGRQ) Scores
Time frame: 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.

5 secondary outcomes

Change in Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline, 1 year
Change in Forced Vital Capacity (FVC)
Time frame: Baseline, 1 year
Change in Forced Vital Capacity (FVC)
Time frame: Baseline, 6 months
Change in St. George Respiratory Questionnaire (SGRQ) Scores
Time frame: Baseline, 6 months
Change in Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline, 6 months

Results and safety

Results posted to the registry on 29 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low-dose Theophylline Group	50	39
Placebo Group	49	41

Primary outcome: Change in St. George Respiratory Questionnaire (SGRQ) Scores

Time frame: Baseline, 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	Low-dose Theophylline Group n = 39	Placebo Group n = 41
Value	39.02 (21.00)	45.06 (16.87)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low-dose Theophylline Group	5 of 50 (10%)	26 of 50 (52%)	2 of 50
Placebo Group	3 of 49 (6.1%)	19 of 49 (38.8%)	4 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23674502Bonjour 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.
Background: PubMed 29323928Siddharthan 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.
Background: PubMed 18713510Moran-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.
Background: PubMed 28848808Perez-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.
Background: PubMed 11693980Ait-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.
Background: PubMed 25680912Beran 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.
Background: PubMed 16267358Barnes 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.
Background: PubMed 20299628Ford 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.
Background: PubMed 18647460Rivera 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.
Background: PubMed 17546309Mendis 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.
Background: PubMed 16916334Zhou 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.
Derived from this study: PubMed 33726828Siddharthan 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.
Individual participant dataSharing planned: No

Related trials for COPD

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Trishul Siddharthan, MD principal investigator

University of Miami

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Theophylline ER in people with COPD and COPD Exacerbation, run by University of Miami at 2 sites in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in St. George Respiratory Questionnaire (SGRQ) Scores (time frame: Baseline, 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03984188, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.