Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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13 November 2017 |
Main ID: |
EUCTR2014-002275-28-HR |
Date of registration:
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02/04/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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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Scientific title:
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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] - DYNAGITO |
Date of first enrolment:
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25/03/2015 |
Target sample size:
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7800 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002275-28 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: yes
Other specify the comparator: Tiotropium Respimat
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Bulgaria
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Canada
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Chile
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Colombia
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Croatia
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Czech Republic
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Denmark
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Ecuador
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Finland
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France
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Germany
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Greece
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Guatemala
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Hong Kong
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Hungary
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India
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Ireland
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Italy
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Japan
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Korea, Republic of
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Latvia
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Lebanon
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Lithuania
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Malaysia
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Mexico
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Montenegro
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Netherlands
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New Zealand
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Norway
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Philippines
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Poland
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Portugal
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Romania
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Russian Federation
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Serbia
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Singapore
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Slovakia
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Slovenia
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South Africa
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Spain
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Sweden
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Switzerland
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Taiwan
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Thailand
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Tunisia
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Turkey
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Ukraine
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United Kingdom
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United States
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Vietnam
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Contacts
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Name:
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QRPE PSC CT Information Disclosure
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Address:
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Binger Strasse 173
55216
Ingelheim am Rhein
Germany |
Telephone:
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+18002430127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim Pharma GmbH & Co. KG |
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Name:
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QRPE PSC CT Information Disclosure
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Address:
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Binger Strasse 173
55216
Ingelheim am Rhein
Germany |
Telephone:
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+18002430127 |
Email:
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clintriage.rdg@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim Pharma GmbH & Co. KG |
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Key inclusion & exclusion criteria
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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/FVC (Forced vital capacity) <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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2300
Exclusion criteria: - Significant disease other than COPD.
- Clinically relevant abnormal baseline haematology, blood chemistry, urinalysis or creatinine > x2 ULN will be excluded regardless of clinical condition
- Current documented history 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 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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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chronic obstructive pulmonary disease MedDRA version: 18.0
Level: LLT
Classification code 10010952
Term: COPD
System Organ Class: 100000004855
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Intervention(s)
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Product Name: Tiotropium 2.5µg/Olodaterol 2.5µg Pharmaceutical Form: Inhalation solution INN or Proposed INN: tiotropium bromide CAS Number: 186691-13-4 Other descriptive name: TIOTROPIUM Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.5- INN or Proposed INN: olodaterol CAS Number: 868049-49-4 Other descriptive name: OLODATEROL Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.5-
Trade Name: Spiriva Respimat 2.5 microgram Pharmaceutical Form: Inhalation solution INN or Proposed INN: tiotropium bromide CAS Number: 186691-13-4 Other descriptive name: TIOTROPIUM Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.5-
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Primary Outcome(s)
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Primary end point(s): 1: Primary endpoint: annualised rate of moderate to severe COPD exacerbation during the treatment period (within 1 day after the last drug administration date).
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Main Objective: To compare the effect of Tiotropium + Olodaterol on COPD exacerbations
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Timepoint(s) of evaluation of this end point: 1: 52 weeks + 1 day
2: 52 weeks+ 1 day
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Secondary Objective: To compare the effect of Tiotropium + Olodaterol on hospitalisation associated with exacerbations and survival
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Secondary Outcome(s)
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Secondary end point(s): 1: Key secondary endpoint: time to first moderate to severe COPD exacerbation during the treatment period (within 1 day after the last drug administration date).
2: Time to all-cause mortality (within 1 day after the last drug administration date).
3: Annualised rate of exacerbation leading to hospitalisation during the treatment period (within 1 day after the last drug administration date).
4: Time to first COPD exacerbations leading to hospitalisation during the treatment period (within 1 day after the last drug administration date).
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Timepoint(s) of evaluation of this end point: 1: 52 weeks + 1 day
2: 52 weeks + 1 day
3: 52 weeks + 1 day
4: 52 weeks + 1 day
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Secondary ID(s)
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1237.19
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2014-002275-28-FI
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Source(s) of Monetary Support
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Boehringer Ingelheim RCV GmbH & Co KG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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