Clinical trial NCT01559116: Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease
Official title: Randomised, Double-blind, Placebo-controlled, 6 Treatment, 4 Period, Incomplete Cross-over Trial to Characterise the 24-hour Lung Function Profiles of Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg, 5/5 µg), Tiotropium (2.5 µg, 5 µg) and Olodaterol (5 µg) (Oral Inhalation, Delivered by the Respimat® Inhaler) After 6 Weeks Once Daily Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-03-21
Enrollment: 219
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.


Eligibility criteria: Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease
2. Relatively stable airway obstruction with a post-bronchodilator FEV1\< 80% of predicted normal and a post-bronchodilator FEV1/FVC \<70%
3. Male or female patients, 40 years of age or older
4. Smoking history of more than 10 pack years
5. Ability to perform technically acceptable pulmonary function tests and maintain records
6. Ability to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler (MDI)

Exclusion criteria:

1. significant disease other than COPD
2. clinically relevant abnormal lab values
3. history of asthma
4. diagnosis of thyrotoxicosis
5. diagnosis of paroxysmal tachycardia
6. history of myocardial infarction
7. unstable or life-threatening cardiac arrhythmia
8. Hospitalization for heart failure within the past year
9. known active tuberculosis
10. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
11. history of life-threatening pulmonary obstruction
12. history of cystic fibrosis
13. clinically evident bronchiectasis
14. history of significant alcohol or drug abuse
15. history of thoracotomy with pulmonary resection
16. oral or patch ß-adrenergics
17. oral corticosteroid medication at unstable doses
18. regular use daytime oxygen therapy for more than one hour per day
19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
21. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
22. Pregnant or nursing women
23. Women of childbearing potential not using a highly effective method of birth control
24. Patients who have previously been randomised in this study or are currently participating in another study
25. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation

Primary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment.
timeFrame: day 1 and week 6
Secondary outcomes:
measure: FEV1 AUC0-12h Response [L] After 6 Weeks Treatment.
timeFrame: day 1 and week 6
measure: FEV1 AUC12-24h Response [L] After 6 Weeks Treatment.
timeFrame: day 1 and week 6
measure: Trough FEV1 Response [L] After 6 Weeks Treatment.
timeFrame: day 1 and week 6
measure: Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment.
timeFrame: day 1 and week 6
measure: FVC AUC0-24h Response [L] After 6 Weeks Treatment.
timeFrame: day 1 and week 6
measure: FVC AUC0-12h Response [L] After 6 Weeks Treatment.
timeFrame: day 1 and week 6
measure: FVC AUC12-24h Response [L] After 6 Weeks Treatment.
timeFrame: day 1 and week 6
measure: Trough FVC Response [L] After 6 Weeks Treatment.
timeFrame: day1 and week 6
measure: Peak (0-3h) FVC Response [L] After 6 Weeks Treatment.
timeFrame: day 1 and week 6
Other outcomes:
Locations:
city: Jasper
country: United States
facility: 1237.20.1204 Boehringer Ingelheim Investigational Site
state: Alabama
city: Easley
country: United States
facility: 1237.20.1203 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 1237.20.1201 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 1237.20.1202 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Genk
country: Belgium
facility: 1237.20.32203 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 1237.20.32201 Boehringer Ingelheim Investigational Site
city: Jambes
country: Belgium
facility: 1237.20.32204 Boehringer Ingelheim Investigational Site
city: Sherbrooke
country: Canada
facility: 1237.20.02201 Boehringer Ingelheim Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: 1237.20.02202 Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: 1237.20.45002 Boehringer Ingelheim Investigational Site
city: Odense C
country: Denmark
facility: 1237.20.45003 Boehringer Ingelheim Investigational Site
city: Silkeborg
country: Denmark
facility: 1237.20.45001 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1237.20.49205 Boehringer Ingelheim Investigational Site
city: Großhansdorf
country: Germany
facility: 1237.20.49204 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1237.20.49203 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1237.20.49206 Boehringer Ingelheim Investigational Site
city: Mannheim
country: Germany
facility: 1237.20.49201 Boehringer Ingelheim Investigational Site
city: Mönchengladbach
country: Germany
facility: 1237.20.49207 Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: 1237.20.49202 Boehringer Ingelheim Investigational Site
city: Gödöllö
country: Hungary
facility: 1237.20.36202 Boehringer Ingelheim Investigational Site
city: Komarom
country: Hungary
facility: 1237.20.36204 Boehringer Ingelheim Investigational Site
city: Pecs
country: Hungary
facility: 1237.20.36203 Boehringer Ingelheim Investigational Site
city: Szarvas
country: Hungary
facility: 1237.20.36201 Boehringer Ingelheim Investigational Site
city: Szazhalombatta
country: Hungary
facility: 1237.20.36205 Boehringer Ingelheim Investigational Site
city: Almelo
country: Netherlands
facility: 1237.20.31205 Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: 1237.20.31202 Boehringer Ingelheim Investigational Site
city: Heerlen
country: Netherlands
facility: 1237.20.31201 Boehringer Ingelheim Investigational Site
city: Hengelo
country: Netherlands
facility: 1237.20.31204 Boehringer Ingelheim Investigational Site
city: Zutphen
country: Netherlands
facility: 1237.20.31203 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Beeh KM, Westerman J, Kirsten AM, Hebert J, Gronke L, Hamilton A, Tetzlaff K, Derom E. The 24-h lung-function profile of once-daily tiotropium and olodaterol fixed-dose combination in chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2015 Jun;32:53-9. doi: 10.1016/j.pupt.2015.04.002. Epub 2015 May 6.