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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.

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

olodaterol

tiotropium

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tiotropium + olodaterol high dose

tiotropium

Arm Description

Once daily 2 puffs solution for inhalation Respimat

Outcomes

Primary Outcome Measures

Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.

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

Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period.

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.

Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period.

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.

Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period.

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.

Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period.

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.

Full Information

NCT ID

NCT02296138

First Posted

November 19, 2014

Last Updated

May 31, 2018

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02296138

Brief Title

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.

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]

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

January 13, 2015 (Actual)

Primary Completion Date

March 8, 2017 (Actual)

Study Completion Date

March 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

7903 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tiotropium + olodaterol high dose

Arm Type

Experimental

Arm Description

Once daily 2 puffs solution for inhalation Respimat

Arm Title

tiotropium

Arm Type

Active Comparator

Arm Description

Once daily 2 puffs solution for inhalation Respimat

Intervention Type

Drug

Intervention Name(s)

olodaterol

Intervention Description

fixed dose combination

Intervention Type

Drug

Intervention Name(s)

tiotropium

Intervention Description

fixed dose combination

Intervention Type

Drug

Intervention Name(s)

tiotropium

Primary Outcome Measure Information:

Title

Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.

Description

Time Frame