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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02006732




Registration number
NCT02006732
Ethics application status
Date submitted
14/10/2013
Date registered
10/12/2013
Date last updated
20/01/2016

Titles & IDs
Public title
Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)
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
2013-002264-24
Secondary ID [2] 0 0
1237.26
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 - olodaterol
Treatment: Drugs - tiotropium

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: olodaterol
fixed dose combination

Treatment: Drugs: tiotropium
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 Based on Data From This Individual Study
Timepoint [3] 0 0
12 weeks treatment
Primary outcome [4] 0 0
St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
Timepoint [4] 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 Based on Data From This Individual Study
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
FVC AUC0-3h Response (Change From Baseline)
Timepoint [4] 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
809
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
1237.26.61004 Boehringer Ingelheim Investigational Site - Concord
Recruitment hospital [2] 0 0
1237.26.61002 Boehringer Ingelheim Investigational Site - Daw Park
Recruitment hospital [3] 0 0
1237.26.61003 Boehringer Ingelheim Investigational Site - Toorak Gardens
Recruitment hospital [4] 0 0
1237.26.61007 Boehringer Ingelheim Investigational Site - Woodville
Recruitment hospital [5] 0 0
1237.26.61005 Boehringer Ingelheim Investigational Site - Murdoch
Recruitment hospital [6] 0 0
1237.26.61001 Boehringer Ingelheim Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Daw Park
Recruitment postcode(s) [3] 0 0
- Toorak Gardens
Recruitment postcode(s) [4] 0 0
- Woodville
Recruitment postcode(s) [5] 0 0
- Murdoch
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Rhode Island
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
West Virginia
Country [14] 0 0
Austria
State/province [14] 0 0
Feldbach
Country [15] 0 0
Austria
State/province [15] 0 0
Grieskirchen
Country [16] 0 0
Austria
State/province [16] 0 0
Linz
Country [17] 0 0
Austria
State/province [17] 0 0
Thalheim bei Wels
Country [18] 0 0
Canada
State/province [18] 0 0
New Brunswick
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
Germany
State/province [21] 0 0
Bamberg
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Bochum
Country [24] 0 0
Germany
State/province [24] 0 0
Dresden
Country [25] 0 0
Germany
State/province [25] 0 0
Frankfurt
Country [26] 0 0
Germany
State/province [26] 0 0
Halberstadt
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Hannover
Country [29] 0 0
Germany
State/province [29] 0 0
Hettstedt
Country [30] 0 0
Germany
State/province [30] 0 0
Leipzig
Country [31] 0 0
Germany
State/province [31] 0 0
Lübeck
Country [32] 0 0
Germany
State/province [32] 0 0
Rüdersdorf
Country [33] 0 0
Germany
State/province [33] 0 0
Schwerin
Country [34] 0 0
Germany
State/province [34] 0 0
Wiesloch
Country [35] 0 0
Greece
State/province [35] 0 0
Athens
Country [36] 0 0
Greece
State/province [36] 0 0
Heraklion
Country [37] 0 0
Greece
State/province [37] 0 0
Nafplio
Country [38] 0 0
Greece
State/province [38] 0 0
Serres
Country [39] 0 0
Greece
State/province [39] 0 0
Thessaloniki
Country [40] 0 0
New Zealand
State/province [40] 0 0
Greenlane East Auckland NZ
Country [41] 0 0
Norway
State/province [41] 0 0
Hamar
Country [42] 0 0
Norway
State/province [42] 0 0
Hønefoss
Country [43] 0 0
Norway
State/province [43] 0 0
Kløfta
Country [44] 0 0
Norway
State/province [44] 0 0
Lierskogen
Country [45] 0 0
Slovakia
State/province [45] 0 0
Bardejov
Country [46] 0 0
Slovakia
State/province [46] 0 0
Humenne
Country [47] 0 0
Slovakia
State/province [47] 0 0
Spisska Nova Ves
Country [48] 0 0
Slovakia
State/province [48] 0 0
Vysne Hagy
Country [49] 0 0
South Africa
State/province [49] 0 0
Cape Town
Country [50] 0 0
South Africa
State/province [50] 0 0
Durban
Country [51] 0 0
Sweden
State/province [51] 0 0
Höllviken
Country [52] 0 0
Sweden
State/province [52] 0 0
Lund
Country [53] 0 0
Sweden
State/province [53] 0 0
Stockholm
Country [54] 0 0
Sweden
State/province [54] 0 0
Uddevalla

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/NCT02006732
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

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/NCT02006732