Trial Outcomes & Findings for Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease (NCT NCT01072396)

Last Updated: 2013-12-24

Results Overview

Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

126 participants

Primary outcome timeframe

baseline, six weeks of treatment

Results posted on

2013-12-24

Participant Flow

The study has two stages, in the first (exploratory) stage, the Control group (Healthy volunteer) is compared to the age-gender matched COPD patients in terms of baseline characteristics. In the second (confirmatory) stage, Placebo and Tiotropium are compared using a cross-over. Since the first stage is exploratory it is not reported.

Participant milestones

Participant milestones
Measure	Placebo/Tiotropium Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks	Tiotropium/Placebo Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
Period One STARTED	63	63
Period One COMPLETED	58	61
Period One NOT COMPLETED	5	2
Washout Period STARTED	58	61
Washout Period COMPLETED	58	60
Washout Period NOT COMPLETED	0	1
Period Two STARTED	58	60
Period Two COMPLETED	57	57
Period Two NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo/Tiotropium Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks	Tiotropium/Placebo Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
Period One Adverse Event	1	1
Period One Protocol Violation	2	1
Period One Withdrawal by Subject	2	0
Washout Period Missing termination information	0	1
Period Two Adverse Event	0	3
Period Two Lost to Follow-up	1	0

Baseline Characteristics

Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/Tiotropium n=63 Participants Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks	Tiotropium/Placebo n=63 Participants Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks	Total n=126 Participants Total of all reporting groups
Age, Continuous	61.8 years STANDARD_DEVIATION 9.1 • n=5 Participants	60.5 years STANDARD_DEVIATION 8.6 • n=7 Participants	61.2 years STANDARD_DEVIATION 8.8 • n=5 Participants
Age, Customized <=55 years	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Age, Customized >55 to <=65 years	28 Participants n=5 Participants	23 Participants n=7 Participants	51 Participants n=5 Participants
Age, Customized >65 years	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	33 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	30 Participants n=7 Participants	65 Participants n=5 Participants
Race/Ethnicity, Customized Black	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized White	57 Participants n=5 Participants	57 Participants n=7 Participants	114 Participants n=5 Participants
Smoking Status Ex-smoker	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Smoking Status Currently smokes	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Smoking history	46.0 pack years STANDARD_DEVIATION 24.4 • n=5 Participants	48.1 pack years STANDARD_DEVIATION 20.0 • n=7 Participants	47.0 pack years STANDARD_DEVIATION 22.3 • n=5 Participants
Duration of COPD (Chronic Obstructive Pulmonary Disease)	4.4 years STANDARD_DEVIATION 4.6 • n=5 Participants	5.3 years STANDARD_DEVIATION 5.7 • n=7 Participants	4.9 years STANDARD_DEVIATION 5.2 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, six weeks of treatment

Population: Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.

Outcome measures

Outcome measures
Measure	Placebo n=111 Participants Patients who received placebo in period one or period two	Tiotropium n=111 Participants Patients who received tiotropium in period one or period two
Change From Baseline in Inspiratory Capacity (IC) at Isotime	0.0035 liter Standard Error 0.02	0.07 liter Standard Error 0.02

SECONDARY outcome

Timeframe: six weeks of treatment

Population: Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.

CWR exercise duration calculated as the length of time of the exercise period

Outcome measures

Outcome measures
Measure	Placebo n=111 Participants Patients who received placebo in period one or period two	Tiotropium n=111 Participants Patients who received tiotropium in period one or period two
Constant Work Rate (CWR) Endurance Time	6.0796 seconds Standard Error 0.0313	6.1458 seconds Standard Error 0.0313

SECONDARY outcome

Timeframe: baseline, six weeks of treatment

Population: Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.

Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced).

Outcome measures

Outcome measures
Measure	Placebo n=111 Participants Patients who received placebo in period one or period two	Tiotropium n=111 Participants Patients who received tiotropium in period one or period two
Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime	-0.0485 Scores on a scale Standard Error 0.1330	-0.2544 Scores on a scale Standard Error 0.1330

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Tiotropium

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=123 participants at risk Patients who received placebo in period one or period two	Tiotropium n=121 participants at risk Patients who received tiotropium in period one or period two
Gastrointestinal disorders Abdominal hernia	0.81% 1/123 • 16 weeks	0.00% 0/121 • 16 weeks
Infections and infestations Pneumonia	0.81% 1/123 • 16 weeks	0.00% 0/121 • 16 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/123 • 16 weeks	0.83% 1/121 • 16 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna stage unspecified	0.00% 0/123 • 16 weeks	0.83% 1/121 • 16 weeks

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER