NCT01536262

Brief Summary

The primary objective of this study is to assess the safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

July 15, 2015

Completed
Last Updated

July 15, 2015

Status Verified

June 1, 2015

Enrollment Period

1.6 years

First QC Date

February 16, 2012

Results QC Date

June 19, 2015

Last Update Submit

June 19, 2015

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Number (%) of Patients With Drug-related AEs

    Number (%) of patients with drug-related Adverse Events (AEs).

    From first drug administration until 21 days after the last administration, upto 392 days

Secondary Outcomes (2)

  • FEV1 AUC0-3h Response

    Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks

  • Trough FEV1 Response

    Baseline and 1 h, 10 min pre-dose after 52 weeks

Study Arms (3)

Tiotropium + Olodaterol (high dose)

OTHER

Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT

Drug: Tiotropium + OlodaterolDevice: Respimat

Olodaterol

OTHER

Olodaterol solution for inhalation - RESPIMAT

Drug: OlodaterolDevice: Respimat

Tiotropium + Olodaterol (low dose)

OTHER

Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT

Drug: Tiotropium + OlodaterolDevice: Respimat

Interventions

Tiotropium + OlodaterolDRUG

Tiotropium and Olodaterol FDC once daily inhalation

Tiotropium + Olodaterol (low dose)
RespimatDEVICE

Respimat inhaler

Tiotropium + Olodaterol (low dose)
OlodaterolDRUG

Olodaterol once daily inhalation

Olodaterol

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic obstructive pulmonary disease.
  • Relatively stable airway obstruction with post FEV1\< 80% predicted normal and post FEV1/FVC \<70%.
  • Male or female Japanese patients, 40 years of age or older.
  • Smoking history of more than 10 pack years.

You may not qualify if:

  • Significant disease other than COPD
  • Clinically relevant abnormal lab values.
  • History of asthma.
  • Diagnosis of thyrotoxicosis
  • Diagnosis of paroxysmal tachycardia
  • History of myocardial infarction within 1 year of screening visit
  • Unstable or life-threatening cardiac arrhythmia.
  • Hospitalization for heart failure within the past year.
  • Known active tuberculosis.
  • Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
  • History of life-threatening pulmonary obstruction.
  • History of cystic fibrosis.
  • Clinically evident bronchiectasis.
  • History of significant alcohol or drug abuse.
  • Thoracotomy with pulmonary resection
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

1237.22.81015 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

1237.22.81023 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, Japan

Location

1237.22.81009 Boehringer Ingelheim Investigational Site

Hamamatu, Shizuoka, Japan

Location

1237.22.81011 Boehringer Ingelheim Investigational Site

Kishiwada, Osaka, Japan

Location

1237.22.81007 Boehringer Ingelheim Investigational Site

Komatsu, Ishikawa, Japan

Location

1237.22.81028 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, Japan

Location

1237.22.81019 Boehringer Ingelheim Investigational Site

Koto-ku,Tokyo, Japan

Location

1237.22.81021 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, Japan

Location

1237.22.81014 Boehringer Ingelheim Investigational Site

Minami-ku, Kumamoto, Kumamoto, Japan

Location

1237.22.81017 Boehringer Ingelheim Investigational Site

Morioka, Iwate, Japan

Location

1237.22.81004 Boehringer Ingelheim Investigational Site

Nagaoka, Niigata, Japan

Location

1237.22.81029 Boehringer Ingelheim Investigational Site

Nagasaki, Nagasaki, Japan

Location

1237.22.81027 Boehringer Ingelheim Investigational Site

Osakasayama, Osaka, Japan

Location

1237.22.81008 Boehringer Ingelheim Investigational Site

Saku, Nagano-ken, Japan

Location

1237.22.81001 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1237.22.81016 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1237.22.81022 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1237.22.81025 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1237.22.81018 Boehringer Ingelheim Investigational Site

Setagaya-ku, Tokyo, Japan

Location

1237.22.81026 Boehringer Ingelheim Investigational Site

Tagajyo,Miyagi, Japan

Location

1237.22.81010 Boehringer Ingelheim Investigational Site

Takatsuki, Osaka, Japan

Location

1237.22.81020 Boehringer Ingelheim Investigational Site

Toyohashi, Aichi, Japan

Location

1237.22.81030 Boehringer Ingelheim Investigational Site

Unzen, Nagasaki, Japan

Location

1237.22.81003 Boehringer Ingelheim Investigational Site

Yokohama,Kanagawa, Japan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tiotropium-olodaterololodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 22, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 15, 2015

Results First Posted

July 15, 2015

Record last verified: 2015-06

Locations

JP(24)