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Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.

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ClinicalTrials.gov Identifier: NCT02296138
Recruitment Status : Completed
First Posted : November 20, 2014
Results First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: olodaterol Drug: tiotropium Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7903 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]
Actual Study Start Date : January 13, 2015
Actual Primary Completion Date : March 8, 2017
Actual Study Completion Date : March 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period. [ Time Frame: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days ]
    Annualised rate of moderate to severe COPD exacerbations during the actual treatment period was calculated per treatment per patient−year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. Least Squares Means are actually exponentiated.


Secondary Outcome Measures :
  1. Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period. [ Time Frame: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days ]
    Key secondary endpoint: Number of patients with at least one moderate to severe COPD exacerbation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation is presented.

  2. Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period. [ Time Frame: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days ]
    Annualised rate of exacerbations leading to hospitalisation during the actual treatment period was calculated per treatment per patient−year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication.

  3. Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period. [ Time Frame: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days ]
    Number of patients with at least one COPD exacerbation leading to hospitalisation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation leading to hospitalisation is presented.

  4. Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period. [ Time Frame: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days ]
    Number of patients with all-cause mortality occurring during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with all-cause mortality is presented.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female patients, 40 years of age or older.
  • Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/ forced vital capacity (FVC) <70% at Visit 1
  • Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization.
  • Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1.
  • Current or ex-smokers with a smoking history of more than 10 pack years.

Exclusion criteria:

  • Significant disease other than COPD.
  • Clinically relevant abnormal baseline haematology, blood chemistry or creatinine > x2 ULN will be excluded regardless of clinical condition. ( A repeat laboratory evaluation can be conducted if deemed necessary by the investigator.)
  • Current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma
  • A diagnosis of thyrotoxicosis
  • A history of myocardial infarction within 6 months of screening visit.
  • Life-threatening cardiac arrhythmia.
  • Known active tuberculosis.
  • Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed).
  • A history of cystic fibrosis.
  • Clinically relevant bronchiectasis.
  • Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening
  • A history of significant alcohol or drug abuse in the opinion of the investigator.
  • Patients who have undergone thoracotomy with pulmonary resection
  • Patients being treated with oral or patch ß-adrenergics.
  • Patients being treated with oral corticosteroid medication at unstable doses
  • Patients being treated with antibiotics for any reasons within 4 weeks of screening visit
  • Patients being treated with PDE4 inhibitors within 3 months of screening visit
  • Patients who have taken an investigational drug within one month or six half-lives
  • Pregnant or nursing women.
  • Women of childbearing potential not using a highly effective method of birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296138


  Show 818 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Statistical Analysis Plan  [PDF] November 15, 2016
Study Protocol  [PDF] July 15, 2015


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02296138     History of Changes
Other Study ID Numbers: 1237.19
2014-002275-28 ( EudraCT Number: EudraCT )
First Posted: November 20, 2014    Key Record Dates
Results First Posted: June 4, 2018
Last Update Posted: June 4, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Tiotropium Bromide
Olodaterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents