Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02006732
First received: October 14, 2013
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: olodaterol
Drug: tiotropium
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo- and Active-controlled Parallel Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium+ Olodaterol Fixed Dose Combination (Delivered by the Respimat Inhaler) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • FEV1 AUC0-3h response (change from baseline) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Trough FEV1 response (change from baseline) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • SGRQ total score (This endpoint will be evaluated in this study and after combining the data from this and the replicate study 1237.25) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TDI focal score (This endpoint will be evaluated in this study and after combining the data from this and the replicate study 1237.25) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • FVC AUC0-3h response (change from baseline) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Trough FVC response (change from baseline) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tiotropium + olodaterol low dose
Once daily 2 puffs solution for inhalation Respimat
Drug: olodaterol
fixed dose combination
Drug: tiotropium
fixed dose combination
Experimental: tiotropium + olodaterol high dose
Once daily 2 puffs solution for inhalation Respimat
Drug: olodaterol
fixed dose combination
Drug: tiotropium
fixed dose combination
Active Comparator: tiotropium
Once daily 2 puffs solution for inhalation Respimat
Drug: tiotropium
Placebo Comparator: placebo
Once daily 2 puffs solution for inhalation Respimat
Drug: placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis chronic obstructive pulmonary disease
  • Relatively stable airway obstruction with post FEV1 >=30 and < 80% predicted normal and post FEV1/ FVC < 70%
  • Male or female patients, 40 years of age or more
  • Smoking history more than 10 pack years

Exclusion criteria:

  • Significant diseases other than COPD
  • History of asthma
  • COPD exacerbation in previous 3 months
  • Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program.
  • Pregnant or nursing women
  • Patients unable to comply with pulmonary medication restrictions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02006732

  Show 78 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02006732     History of Changes
Other Study ID Numbers: 1237.26, 2013-002264-24
Study First Received: October 14, 2013
Last Updated: September 3, 2014
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Administration
Austria: Medicines and Medical Devices Agency
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Sweden: Medical Products Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014