Trial Outcomes & Findings for Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients (NCT NCT00680056)

Last Updated: 2010-01-20

Results Overview

Percentage change from baseline in time to the limit of tolerance on a high intensity constant-speed treadmill exercise test (with a speed corresponding to 80% of that obtained during incremental test)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

33 participants

Primary outcome timeframe

Baseline and after 2 weeks with each treatment

Results posted on

2010-01-20

Participant Flow

University clinic Period: January-August (2008)

After screening and before first baseline visit, patients discontinued long-acting β2-agonists and inhaled anticholinergic bronchodilators (run in period). 50 patients recruited; 33 screened. 7 excluded: 4 due to chronic obstructive pulmonary disease (COPD) exacerbation and 3 due to protocol violation.

Participant milestones

Participant milestones
Measure	Formoterol Plus Placebo (Tiotropium) First Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).	Formoterol Plus Tiotropium First Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
First Intervention STARTED	16	17
First Intervention COMPLETED	15	15
First Intervention NOT COMPLETED	1	2
Washout Period of One Week STARTED	15	15
Washout Period of One Week COMPLETED	15	15
Washout Period of One Week NOT COMPLETED	0	0
Second Intervention STARTED	15	15
Second Intervention COMPLETED	12	14
Second Intervention NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Formoterol Plus Placebo (Tiotropium) First Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).	Formoterol Plus Tiotropium First Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).
First Intervention Mainly Exacerbation of COPD	1	2
Second Intervention Protocol Violation	3	1

Baseline Characteristics

Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Formoterol Plus Placebo (Tiotropium) First n=16 Participants Formoterol + Placebo (Tiotropium) in first intervention period and Formoterol + Tiotropium in second intervention period (after washout period).	Formoterol Plus Tiotropium First n=17 Participants Formoterol + Tiotropium in first intervention period and Formoterol + placebo in second intervention period (after washout period).	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	6 Participants n=7 Participants	16.0 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	11 Participants n=7 Participants	17.0 Participants n=5 Participants
Age Continuous	62.0 years STANDARD_DEVIATION 8.2 • n=5 Participants	67.2 years STANDARD_DEVIATION 6.8 • n=7 Participants	64.9 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7.0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	15 Participants n=7 Participants	26.0 Participants n=5 Participants
Region of Enrollment Brazil	16 participants n=5 Participants	17 participants n=7 Participants	33.0 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 2 weeks with each treatment

Population: The specific period where the patient received a given treatment were analysed together.

Outcome measures

Outcome measures
Measure	Formoterol Plus Placebo (Tiotropium) Treatment n=26 Participants Formoterol + Placebo (Tiotropium) in either first intervention period or second intervention period.	Formoterol Plus Tiotropium Treatment n=26 Participants Formoterol + Tiotropium in either first intervention period or second intervention period.
Percentage Change in Exercise Tolerance From Baseline at 2 Weeks	68 Percentage change Standard Error 14	124 Percentage change Standard Error 27

SECONDARY outcome

Timeframe: After 2 week of each treatment

TDI is a multidimensional clinical instrument developed to provide a comprehensive assessment of change in dyspnea after an intervention, considering three components (functional impairment, magnitude of task, and magnitude of effort). It ranges from -9 (major deterioration) to +9 (major improvement).

Outcome measures

Outcome measures
Measure	Formoterol Plus Placebo (Tiotropium) Treatment n=26 Participants Formoterol + Placebo (Tiotropium) in either first intervention period or second intervention period.	Formoterol Plus Tiotropium Treatment n=26 Participants Formoterol + Tiotropium in either first intervention period or second intervention period.
Mean Score on the Transitional Dyspnea Index (TDI)	2.9 score on scale Standard Deviation 2.5	3.8 score on scale Standard Deviation 1.8

Adverse Events

Formoterol Plus Placebo (Tiotropium) First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Formoterol Plus Tiotropium First

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

Danilo Berton

UNIFESP

Phone: 55-11-55718384

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place