Trial Outcomes & Findings for Enhancement of in-Vitro GC Function in Patients With COPD (NCT NCT00241631)

NCT ID: NCT00241631

Last Updated: 2019-12-04

Results Overview

Supernatant collect, cell pellets count on slides

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 49 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2019-12-04

Participant Flow

Participant milestones

Measure	Placebo Inhaled Theophylline placebo capsule, then inhaled placebo, then active Theophylline	Steroid Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline
Run in (2 Weeks) STARTED	25	24
Run in (2 Weeks) COMPLETED	22	21
Run in (2 Weeks) NOT COMPLETED	3	3
Phase 1 (4 Weeks) STARTED	22	21
Phase 1 (4 Weeks) COMPLETED	14	16
Phase 1 (4 Weeks) NOT COMPLETED	8	5
Wash Out (2 Weeks) STARTED	14	16
Wash Out (2 Weeks) COMPLETED	14	16
Wash Out (2 Weeks) NOT COMPLETED	0	0
Phase 2 (4 Weeks) STARTED	14	16
Phase 2 (4 Weeks) COMPLETED	14	16
Phase 2 (4 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Placebo Inhaled Theophylline placebo capsule, then inhaled placebo, then active Theophylline	Steroid Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline
Run in (2 Weeks) Physician Decision	3	3
Phase 1 (4 Weeks) sore throat	1	0
Phase 1 (4 Weeks) Withdrawal by Subject	4	4
Phase 1 (4 Weeks) Lost to Follow-up	3	0
Phase 1 (4 Weeks) Lack of Efficacy	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Placebo n=14 Participants Inhaled Theophylline placebo capsule, then inhaled placebo, then active Theophylline	Steroid n=16 Participants Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline	Total n=30 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 2.2 • n=14 Participants	69 years STANDARD_DEVIATION 1.9 • n=16 Participants	65 years STANDARD_DEVIATION 2 • n=30 Participants
Sex: Female, Male Female	3 Participants n=14 Participants	2 Participants n=16 Participants	5 Participants n=30 Participants
Sex: Female, Male Male	11 Participants n=14 Participants	14 Participants n=16 Participants	25 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	14 participants n=14 Participants	16 participants n=16 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: Using marginal means as results

Supernatant collect, cell pellets count on slides

Outcome measures

Measure	Placebo n=14 Participants Inhaled Theophylline placebo capsule, then inhaled placebo, then active Theophylline	Steroid n=16 Participants Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline
Sputum Inflammatory Cell Counts	5.42 millions cells/ ml Interval 3.56 to 8.2	3.89 millions cells/ ml Interval 2.6 to 5.76

SECONDARY outcome

Timeframe: 10 weeks

Interleukin 8 (IL8) assessed from sputum

Outcome measures

Measure	Placebo n=14 Participants Inhaled Theophylline placebo capsule, then inhaled placebo, then active Theophylline	Steroid n=16 Participants Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline
Interleukin 8 (IL8)	33.3 ng/mL Interval 20.0 to 56.0	28.3 ng/mL Interval 19.0 to 42.0

SECONDARY outcome

Timeframe: 10 weeks

Total eosinophils cells assessed from sputum

Outcome measures

Measure	Placebo n=14 Participants Inhaled Theophylline placebo capsule, then inhaled placebo, then active Theophylline	Steroid n=16 Participants Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline
Total Sputum Eosinophils	0.132 millions cells/ml Interval 0.09 to 0.2	0.053 millions cells/ml Interval 0.03 to 0.1

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Steroid

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=14 participants at risk Inhaled Theophylline placebo capsule, then inhaled placebo, then active Theophylline	Steroid n=16 participants at risk Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline
Gastrointestinal disorders Nausea	0.00% 0/14 • 10 weeks	25.0% 4/16 • Number of events 4 • 10 weeks

Additional Information

Ian M Adcock

Imperial College London

Phone: +44 (0)20 7594 7840

Email: ian.adcock@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place