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

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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

FEv1 AUC0-3h response [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
Trough FEV1 response [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
SGRQ total score (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 (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 ]
FVC AUC0-3h response [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
Trough FVC response [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
FEV1 AUC0-12h response [L] in sub-set of patients with 12-hour PFTs [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
FEV1 peak0-3 response [L] [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
FVC peak0-3 response [L] [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
FVC AUC0-12h response [L] in sub-set of patients with 12-hour PFTs [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	2539
Study Start Date:	September 2011
Estimated Study Completion Date:	November 2013
Primary Completion Date:	April 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:

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

Exclusion criteria:

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
Oral ß-adrenergics.
Oral corticosteroid medication at unstable doses
Regular use of daytime oxygen therapy for more than one hour per day
Pulmonary rehabilitation program in the six weeks prior to the screening visit
Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
Pregnant or nursing women.
Women of childbearing potential not using a highly effective method of birth control
Patients who are unable to comply with pulmonary medication restrictions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431287

Show 241 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01431287 History of Changes
Other Study ID Numbers:	1237.6, 2009-010669-22
Study First Received:	September 8, 2011
Last Updated:	May 15, 2013
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 Great Britain: 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 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 May 19, 2013