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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
The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.
Trial website
https://clinicaltrials.gov/study/NCT01964352
Trial related presentations / publications
Buhl R, de la Hoz A, Xue W, Singh D, Ferguson GT. Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naive to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials. Adv Ther. 2020 Oct;37(10):4175-4189. doi: 10.1007/s12325-020-01411-0. Epub 2020 Jul 15.
Buhl R, Singh D, de la Hoz A, Xue W, Ferguson GT. Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO(R) and OTEMTO(R) Studies. Adv Ther. 2020 Aug;37(8):3485-3499. doi: 10.1007/s12325-020-01373-3. Epub 2020 May 27.
Singh D, Gaga M, Schmidt O, Bjermer L, Gronke L, Voss F, Ferguson GT. Effects of tiotropium + olodaterol versus tiotropium or placebo by COPD disease severity and previous treatment history in the OTEMTO(R) studies. Respir Res. 2016 Jun 18;17(1):73. doi: 10.1186/s12931-016-0387-7.
Singh D, Ferguson GT, Bolitschek J, Gronke L, Hallmann C, Bennett N, Abrahams R, Schmidt O, Bjermer L. Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015 Oct;109(10):1312-9. doi: 10.1016/j.rmed.2015.08.002. Epub 2015 Aug 12.
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01964352