Trial Outcomes & Findings for Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD (NCT NCT00860938)

NCT ID: NCT00860938

Last Updated: 2019-07-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 90 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-07-23

Participant Flow

out patient clinic

run-in

Participant milestones

Measure	Budesonide	Placebo
Overall Study STARTED	45	45
Overall Study COMPLETED	31	37
Overall Study NOT COMPLETED	14	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predictor for an Additional Benefit of Inhaled Corticosteroid in Patients Treated With Tiotropium for COPD

Baseline characteristics by cohort

Measure	Budesonide n=31 Participants	Placebo n=37 Participants	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	23 Participants n=7 Participants	41 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 16 • n=5 Participants	62 years STANDARD_DEVIATION 22 • n=7 Participants	61.5 years STANDARD_DEVIATION 20 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	19 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment Switzerland	31 participants n=5 Participants	37 participants n=7 Participants	68 participants n=5 Participants
FEV1/FVC	63 % STANDARD_DEVIATION 10 • n=5 Participants	64 % STANDARD_DEVIATION 10 • n=7 Participants	64 % STANDARD_DEVIATION 10 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: per protocol

Outcome measures

Measure	Budesonide n=31 Participants	Placebo n=37 Participants
Change in Lung Function (FEV1)	0.05 litres Standard Deviation 0.01	-0.05 litres Standard Deviation 0.01

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Budesonide n=31 Participants	Placebo n=37 Participants
The Proportion Who Complete Follow-up Without Developing an Exacerbation	31 number of participants	37 number of participants

SECONDARY outcome

Timeframe: 12 weeks, baseline to 3 months follow-up

St. George Respiratory Questionnaire (SGRQ). Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.

Scores are calculated for three domains: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale) Scores range from 0 to 100, with higher scores indicating more limitations. Unit of Measure = Units on a scale A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing.

Based on empirical data and interviews with patients, a mean change score of 4 units is associated with slightly efficacious treatment, 8 units for moderately efficacious change and 12 units for very efficacious treatment. The higher the change in units, the better the treatment.

Outcome measures

Measure	Budesonide n=31 Participants	Placebo n=37 Participants
Change in Quality of Life	5.1 units Standard Deviation 5.8	1.8 units Standard Deviation 0.3

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Budesonide n=31 Participants	Placebo n=37 Participants
Change in logRDR Mannitol	0.12 %/mg Standard Deviation 0.1	-0.09 %/mg Standard Deviation 0.01

Adverse Events

Budesonide

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Budesonide n=31 participants at risk	Placebo n=37 participants at risk
Renal and urinary disorders Urosepsis	3.2% 1/31	5.4% 2/37
Cardiac disorders unstable angina pectoris	3.2% 1/31	5.4% 2/37

Other adverse events

Measure	Budesonide n=31 participants at risk	Placebo n=37 participants at risk
Respiratory, thoracic and mediastinal disorders Acute exacerbation	6.5% 2/31	5.4% 2/37

Additional Information

Jörg D. Leuppi, MD PhD, principle investigator

University Hospital Basel, Switzerland

Phone: +41-61-2654294

Email: jleuppi@uhbs.ch

Results disclosure agreements

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