Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01431287
First received: September 8, 2011
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2]

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • FEV1 AUC0-3h response [L] on Day 169 [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • Trough FEV1 response [L] on Day 170 [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • SGRQ total score on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • TDI focal score on Day 169 (Key secondary endpoint; This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC0-3h response [L] on Day 1, Day 85 and Day 365 [ Time Frame: 52 weeks treatment ] [ Designated as safety issue: No ]
  • Trough FEV1 response [L] on Day 15, Day 43, Day 85, Day 169 and Day 365 [ Time Frame: 52 weeks treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC0-12h response [L] in sub-set of patients with 12-hour PFTs on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FVC AUC0-12h response [L] in sub-set of patients with 12-hour PFTs on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC0-24h response [L] in sub-set of patients with 12-hour PFTs on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • FVC AUC0-3h response [L] on Day 1, Day 85 and Day 365 [ Time Frame: 52 weeks treatment ] [ Designated as safety issue: No ]
  • Trough FVC response [L] on Day 15, Day 43, Day 85, Day 170 and Day 365 [ Time Frame: 52 weeks treatment ] [ Designated as safety issue: No ]
  • FVC AUC0-24h response [L] in sub-set of patients with 12-hour PFTs on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • SGRQ total score on Day 85 and Day 365 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • TDI focal score on Day 43, Day 85 and Day 365 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 2539
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tiotropium+olodaterol high dose FDC
Once daily 2 puffs solution for inhalation Respimat
Drug: tiotropium + olodaterol
fixed dose combination
Experimental: tiotropium+olodaterol low dose FDC
Once daily 2 puffs solution for inhalation Respimat
Drug: tiotropium + olodaterol
fixed dose combination
Active Comparator: olodaterol
Once daily 2 puffs solution for inhalation Respimat
Drug: olodaterol
one dose only
Active Comparator: tiotropium low dose
Once daily 2 puffs solution for inhalation Respimat
Drug: tiotropium
low dose or high dose
Active Comparator: tiotropium high dose
Once daily 2 puffs solution for inhalation Respimat
Drug: tiotropium
low dose or high dose

  Eligibility

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

Inclusion criteria:

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

Exclusion criteria:

  1. Significant disease other than COPD
  2. Clinically relevant abnormal lab values.
  3. History of asthma.
  4. Diagnosis of thyrotoxicosis
  5. Diagnosis of paroxysmal tachycardia
  6. History of myocardial infarction within 1 year of screening visit
  7. Unstable or life-threatening cardiac arrhythmia.
  8. Hospitalization for heart failure within the past year.
  9. Known active tuberculosis.
  10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
  11. History of life-threatening pulmonary obstruction.
  12. History of cystic fibrosis.
  13. Clinically evident bronchiectasis.
  14. History of significant alcohol or drug abuse.
  15. Thoracotomy with pulmonary resection
  16. Oral ß-adrenergics.
  17. Oral corticosteroid medication at unstable doses
  18. Regular use of daytime oxygen therapy for more than one hour per day
  19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
  20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
  21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
  22. Pregnant or nursing women.
  23. Women of childbearing potential not using a highly effective method of birth control
  24. Patients who are unable to comply with pulmonary medication restrictions
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01431287

  Show 240 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: NCT01431287     History of Changes
Other Study ID Numbers: 1237.6, 2009-010669-22
Study First Received: September 8, 2011
Last Updated: March 28, 2014
Health Authority: Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
China: Food and Drug Administration
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Agency for Medicinal Product and Medical Devices
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Japan: Ministry of Health, Labor and Welfare
Mexico: Federal Commission for Protection Against Health Risks
Norway: Norwegian Medicines Agency
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014