Trial Outcomes & Findings for Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD (NCT NCT03984188)
NCT ID: NCT03984188
Last Updated: 2024-11-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
Baseline, 1 year
Results posted on
2024-11-15
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
49
|
|
Overall Study
6 Months
|
42
|
47
|
|
Overall Study
COMPLETED
|
39
|
41
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Death
|
2
|
4
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
Baseline Characteristics
Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD
Baseline characteristics by cohort
| Measure |
Low-dose Theophylline Group
n=50 Participants
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
|
Placebo Group
n=49 Participants
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
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
50 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Uganda
|
50 participants
n=99 Participants
|
49 participants
n=107 Participants
|
99 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 yearThe 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.
Outcome measures
| Measure |
Low-dose Theophylline Group
n=39 Participants
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
|
Placebo Group
n=41 Participants
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
|
|---|---|---|
|
Change in St. George Respiratory Questionnaire (SGRQ) Scores
|
39.02 score on a scale
Standard Deviation 21.00
|
45.06 score on a scale
Standard Deviation 16.87
|
SECONDARY outcome
Timeframe: Baseline, 1 yearFEV1 measures how much air a person can exhale during a forced breath. The amount of air exhaled during the first second measured in liters.
Outcome measures
| Measure |
Low-dose Theophylline Group
n=38 Participants
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
|
Placebo Group
n=38 Participants
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
|
|---|---|---|
|
Change in Forced Expiratory Volume in One Second (FEV1)
|
1.40 Liters
Standard Deviation 0.51
|
1.45 Liters
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline, 1 yearFVC measures how much air a person can exhale at the end of a forced breath measured in liters.
Outcome measures
| Measure |
Low-dose Theophylline Group
n=38 Participants
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
|
Placebo Group
n=38 Participants
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
|
|---|---|---|
|
Change in Forced Vital Capacity (FVC)
|
2.47 Liters
Standard Deviation 0.68
|
2.58 Liters
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsFVC measures how much air a person can exhale at the end of a forced breath measured in liters.
Outcome measures
| Measure |
Low-dose Theophylline Group
n=42 Participants
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
|
Placebo Group
n=44 Participants
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
|
|---|---|---|
|
Change in Forced Vital Capacity (FVC)
|
2.51 Liters
Standard Deviation 0.68
|
2.52 Liters
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsThe 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.
Outcome measures
| Measure |
Low-dose Theophylline Group
n=42 Participants
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
|
Placebo Group
n=47 Participants
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
|
|---|---|---|
|
Change in St. George Respiratory Questionnaire (SGRQ) Scores
|
37.86 score on a scale
Standard Deviation 21.37
|
44.45 score on a scale
Standard Deviation 19.48
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsFEV1 measures how much air a person can exhale during a forced breath. The amount of air exhaled during the first second measured in liters.
Outcome measures
| Measure |
Low-dose Theophylline Group
n=42 Participants
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
|
Placebo Group
n=44 Participants
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
|
|---|---|---|
|
Change in Forced Expiratory Volume in One Second (FEV1)
|
1.40 Liters
Standard Deviation 0.51
|
1.40 Liters
Standard Deviation 0.62
|
Adverse Events
Low-dose Theophylline Group
Serious events: 5 serious events
Other events: 26 other events
Deaths: 2 deaths
Placebo Group
Serious events: 3 serious events
Other events: 19 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Low-dose Theophylline Group
n=50 participants at risk
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
|
Placebo Group
n=49 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Respiratory Failure
|
6.0%
3/50 • Number of events 3 • 1 year
|
4.1%
2/49 • Number of events 2 • 1 year
|
|
Nervous system disorders
Hospitalization for Stroke
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/49 • 1 year
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/50 • 1 year
|
2.0%
1/49 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Hospitalization for anemia
|
0.00%
0/50 • 1 year
|
2.0%
1/49 • Number of events 1 • 1 year
|
|
General disorders
Hospitalization for failure to thrive
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/49 • 1 year
|
Other adverse events
| Measure |
Low-dose Theophylline Group
n=50 participants at risk
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
|
Placebo Group
n=49 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
28.0%
14/50 • 1 year
|
20.4%
10/49 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthalgia/Myalgia
|
6.0%
3/50 • 1 year
|
10.2%
5/49 • 1 year
|
|
Renal and urinary disorders
Change in urinary frequency
|
4.0%
2/50 • 1 year
|
0.00%
0/49 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
14.0%
7/50 • 1 year
|
8.2%
4/49 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/50 • 1 year
|
2.0%
1/49 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place