Trial Outcomes & Findings for A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease (NCT NCT00995475)

NCT ID: NCT00995475

Last Updated: 2023-05-19

Results Overview

C-reactive protein

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 18 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2023-05-19

Participant Flow

This is a randomised, double blind placebo controlled cross over trial design will be used. Following a two-week steroid tapering process and a two-week run in period, two randomised treatment periods will follow. Each will be one month in duration and will be separated by a two-week wash-out period.

Participant milestones

Measure	Inhaled Corticosteroid One Month FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. Then two-week washout before placebo. Fluticasone propionate	Placebo Control One Month FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. Then two-week washout before FP. Placebo
First Intervention STARTED	9	9
First Intervention COMPLETED	9	9
First Intervention NOT COMPLETED	0	0
Wash-out Two Week STARTED	9	9
Wash-out Two Week COMPLETED	9	9
Wash-out Two Week NOT COMPLETED	0	0
Second Intervention STARTED	9	9
Second Intervention COMPLETED	9	9
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease

Baseline characteristics by cohort

Measure	Inhaled Corticosteroid, Then Placebo or Vice Versa n=18 Participants FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. Then 2 weeks of wash-out. Then followed by FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants
Age, Categorical >=65 years	11 Participants n=93 Participants
Sex: Female, Male Female	6 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Region of Enrollment United Kingdom	18 participants n=93 Participants

PRIMARY outcome

Timeframe: 4 weeks

C-reactive protein

Outcome measures

Measure	Inhaled Corticosteroid n=18 Participants FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. Fluticasone propionate	Placebo Control n=18 Participants FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. Placebo
CRP	2.9 mg/L Interval 1.3 to 6.4	2.0 mg/L Interval 1.1 to 3.4

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Inhaled Corticosteroid n=18 Participants FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. Fluticasone propionate	Placebo Control n=18 Participants FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. Placebo
Alveolar Nitric Oxide	1.7 ppb Interval 1.2 to 2.4	3.1 ppb Interval 2.6 to 3.8

SECONDARY outcome

Timeframe: 4 weeks

Overnight urinary cortisol creatinine ratio

Outcome measures

Measure	Inhaled Corticosteroid n=18 Participants FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. Fluticasone propionate	Placebo Control n=18 Participants FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. Placebo
OUCC	2.7 nmol/mmol Interval 1.6 to 4.6	8.8 nmol/mmol Interval 6.7 to 11.4

Adverse Events

Inhaled Corticosteroid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Brian J Lipworth

University of Dundee

Phone: +44 1382 383188

Email: b.j.lipworth@dundee.ac.uk

Results disclosure agreements

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