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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01964352




Registration number
NCT01964352
Ethics application status
Date submitted
14/10/2013
Date registered
17/10/2013
Date last updated
25/11/2015

Titles & IDs
Public title
Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)
Scientific title
A Randomised, Double-blind, Placebo- and Active-controlled Parallel Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (Delivered by the Respimat Inhaler) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 0 0
2013-002243-29
Secondary ID [2] 0 0
1237.25
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tiotropium
Treatment: Drugs - olodaterol
Treatment: Drugs - tiotropium
Treatment: Drugs - olodaterol

Experimental: tiotropium + olodaterol low dose - Once daily 2 puffs solution for inhalation Respimat

Experimental: tiotropium + olodaterol high dose - Once daily 2 puffs solution for inhalation Respimat

Active comparator: tiotropium - Once daily 2 puffs solution for inhalation Respimat

Placebo comparator: placebo - Once daily 2 puffs solution for inhalation Respimat


Treatment: Drugs: tiotropium
fixed dose combination

Treatment: Drugs: olodaterol
fixed dose combination

Treatment: Drugs: tiotropium
fixed dose combination

Treatment: Drugs: olodaterol
fixed dose combination
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
FEV1 AUC0-3h Response
Timepoint [1] 0 0
baseline and 12 weeks
Primary outcome [2] 0 0
Trough FEV1 Response (Change From Baseline)
Timepoint [2] 0 0
baseline and 12 weeks
Primary outcome [3] 0 0
St. George's Respiratory Questionnaire (SGRQ) Total Score
Timepoint [3] 0 0
12 weeks treatment
Secondary outcome [1] 0 0
Trough Forced Vital Capacity (FVC) Response (Change From Baseline)
Timepoint [1] 0 0
baseline and 12 weeks
Secondary outcome [2] 0 0
TDI Focal Score
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
FVC AUC0-3h Response (Change From Baseline)
Timepoint [3] 0 0
baseline and 12 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

* Diagnosis chronic obstructive pulmonary disease
* Relatively stable airway obstruction with post FEV1 >=30 and < 80% predicted normal and post FEV1/ FVC < 70%
* Male or female patients, 40 years of age or more
* Smoking history more than 10 pack years
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Significant diseases other than COPD
* History of asthma
* COPD exacerbation in previous 3 months
* Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program.
* Pregnant or nursing women
* Patients unable to comply with pulmonary medication restrictions

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
813
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussel
Country [14] 0 0
Belgium
State/province [14] 0 0
Eupen
Country [15] 0 0
Belgium
State/province [15] 0 0
Lebbeke
Country [16] 0 0
Belgium
State/province [16] 0 0
Turnhout
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Jindrichuv Hradec
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Karlovy Vary-Drahovice
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Neratovice
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Prague
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Rokycany
Country [26] 0 0
Denmark
State/province [26] 0 0
Hellerup
Country [27] 0 0
Denmark
State/province [27] 0 0
Odense
Country [28] 0 0
Denmark
State/province [28] 0 0
Silkeborg
Country [29] 0 0
Denmark
State/province [29] 0 0
Ålborg
Country [30] 0 0
Finland
State/province [30] 0 0
Pori
Country [31] 0 0
Finland
State/province [31] 0 0
Turku
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Großhansdorf
Country [34] 0 0
Germany
State/province [34] 0 0
Halle/Saale
Country [35] 0 0
Germany
State/province [35] 0 0
Hamburg
Country [36] 0 0
Germany
State/province [36] 0 0
Hannover
Country [37] 0 0
Germany
State/province [37] 0 0
Koblenz
Country [38] 0 0
Germany
State/province [38] 0 0
Mainz
Country [39] 0 0
Germany
State/province [39] 0 0
Neu-Isenburg
Country [40] 0 0
Germany
State/province [40] 0 0
Oschersleben
Country [41] 0 0
Germany
State/province [41] 0 0
Rodgau
Country [42] 0 0
Germany
State/province [42] 0 0
Rosenheim
Country [43] 0 0
Germany
State/province [43] 0 0
Teuchern
Country [44] 0 0
South Africa
State/province [44] 0 0
Bloemfontein
Country [45] 0 0
South Africa
State/province [45] 0 0
Cape Town
Country [46] 0 0
South Africa
State/province [46] 0 0
Morningside, Sandton
Country [47] 0 0
South Africa
State/province [47] 0 0
Parow
Country [48] 0 0
South Africa
State/province [48] 0 0
Pretoria
Country [49] 0 0
South Africa
State/province [49] 0 0
Umkomaas
Country [50] 0 0
Spain
State/province [50] 0 0
Alicante
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Mérida
Country [53] 0 0
Spain
State/province [53] 0 0
Pozuelo de Alarcón
Country [54] 0 0
Spain
State/province [54] 0 0
Vic
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Bradford
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Chertsey
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Chester
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Chippenham
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01964352