NCT02720757

Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)

Terminated Results posted Last updated 16 April 2019

What this trial tests

trial testing Spiolto Respimat in Pulmonary Disease, Chronic Obstructive in 132 participants. Terminated before completion.

Timeline

26 August 2016

Primary endpoint
14 December 2017

14 December 2017

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	132
Start date	26 August 2016
Primary completion	14 December 2017
Estimated completion	14 December 2017
Sites	6 locations across Denmark, Netherlands, Belgium, Sweden, Portugal, Luxembourg

Drugs / interventions tested

• Spiolto Respimat

Conditions studied

• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

40 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline Primary · Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)

"Therapeutic success" is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3. The scores over the 10 questions will be summed, resulting in a value

Group	Value	95% CI
Tiotropium + Olodaterol FDC	44.90	32.23 – 54.78

Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later) Secondary · Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)

Change in PF-10 score was determined by taking into account the individual change of each patient between Visit 1 and Visit 2. PF questionnaire, is a sub-domain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little", or "No, not limited at all", with a score of 1, 2, or 3. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all

Group	Value	95% CI
Tiotropium + Olodaterol FDC	7.64	± 17.60

General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) Secondary · Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)

The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8(excellent). PGE will be completed before and approx. 6 weeks after treatment initiation. Count of patients with PGE score 2, 3, 4, 5, 6, 7, 8 are presented for Visit 1 and Visit 2.

Visit 1_score (2)

Group	Value	95% CI
Tiotropium + Olodaterol FDC	7

Visit 2_score (2)

Group	Value	95% CI
Tiotropium + Olodaterol FDC	1

Visit 1_score (3)

Group	Value	95% CI
Tiotropium + Olodaterol FDC	18

Visit 2_score (3)

Group	Value	95% CI
Tiotropium + Olodaterol FDC	14

Visit 1_score (4)

Group	Value	95% CI
Tiotropium + Olodaterol FDC	28

Visit 2_score (4)

Group	Value	95% CI
Tiotropium + Olodaterol FDC	14

Visit 1_score (5)

Group	Value	95% CI
Tiotropium + Olodaterol FDC	18

Visit 2_score (5)

Group	Value	95% CI
Tiotropium + Olodaterol FDC	14

Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction Secondary · Visit 2 (approx. 6 weeks post baseline)

A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented.

Very satisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	20

Satisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	43

Rather satisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	22

Neither satisfied nor dissatisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	14

Rather dissatisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	4

Dissatisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	3

Very dissatisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	1

Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device Secondary · Visit 2 (approx. 6 weeks post baseline)

A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented.

Very satisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	25

Satisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	45

Rather satisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	20

Neither satisfied nor dissatisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	10

Rather dissatisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	5

Dissatisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	2

Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device Secondary · Visit 2 (approx. 6 weeks post baseline)

A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented.

Very satisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	33

Satisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	45

Rather satisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	14

Neither satisfied nor dissatisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	9

Rather dissatisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	5

Dissatisfied

Group	Value	95% CI
Tiotropium + Olodaterol FDC	1

Sponsor's own description

The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks.

A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to Visit 2 (final visit at the end of the study, approx. 6 weeks after Visit 1), as well as patient satisfaction with Spiolto® Respimat® at Visit 2.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Improvement In Self-Reported Physical Functioning With Tiotropium/Olodaterol In Central And Eastern European COPD Patients.
   Valipour A, Tamm M, Kociánová J, Bayer V, et al · · 2019 · cited 14× · PMID 31632003 · DOI 10.2147/copd.s204388
2. Swiss Experience in Therapy With Dual Bronchodilation in Chronic Obstructive Pulmonary Disease in Relation to Self-Reported Physical Functionality.
   Spielmanns M, Tamm M, Schildge S, Valipour A. · · 2021 · cited 3× · PMID 34394782 · DOI 10.14740/jocmr4542