Clinical trial NCT01969721: Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients
Official title: Randomized, Double-blind, Double-dummy, Active-controlled, 4 Period Complete Cross-over Study to Compare the Effect on Lung Function of 6 Weeks Once Daily Treatment With Orally Inhaled Tiotropium+Olodaterol Fixed Dose Combination Delivered by the Respimat® Inhaler vs. 6 Weeks Twice Daily Treatment With Fluticasone Propionate+Salmeterol Fixed Dose Combination Delivered by the Accuhaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 229
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 objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC \[2.5/ 5µg and 5/ 5µg\] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC \[250/50µg and 500/50µg\] delivered by the Accuhaler® 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 30% \</= Forced Expiratory Volume in 1 second (FEV1)\<80% of predicted normal and a post-bronchodilator FEV1/(Forced Vital Capacity)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, Accuhaler and from a metered dose inhaler (MDI)

Exclusion criteria:

1. Significant disease other than COPD
2. COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months.
3. Clinically relevant abnormal lab values
4. History of asthma
5. Diagnosis of thyrotoxicosis
6. Diagnosis of paroxysmal tachycardia
7. History of myocardial infarction
8. Unstable or life-threatening cardiac arrhythmia
9. Hospitalization for heart failure within the past year
10. Known active tuberculosis
11. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
12. History of life-threatening pulmonary obstruction
13. History of cystic fibrosis
14. Clinically evident bronchiectasis
15. History of significant alcohol or drug abuse
16. History of thoracotomy with pulmonary resection
17. oral or patch ß-adrenergics
18. Oral corticosteroid medication within 6 weeks prior to Visit 1
19. Regular use daytime oxygen therapy for more than one hour per day
20. Pulmonary rehabilitation program in the six weeks prior to the screening visit
21. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
22. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
23. Pregnant or nursing women

Primary outcomes:
measure: FEV1 AUC (0-12h) Change From Patient Baseline After 6 Weeks of Treatment
timeFrame: Baseline and 6 weeks.
Secondary outcomes:
measure: FEV1 AUC (0-24h) Change From Patient Baseline After 6 Weeks of Treatment
timeFrame: Baseline and 6 weeks.
measure: Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment
timeFrame: Baseline and 6 weeks.
measure: FEV1 AUC (12-24h) Change From Patient Baseline After 6 Weeks of Treatment
timeFrame: Baseline and 6 weeks.
measure: FEV1 Peak (0-3h) Change From Patient Baseline After 6 Weeks of Treatment
timeFrame: Baseline and 6 weeks.
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: 1237.11.32002 Boehringer Ingelheim Investigational Site
city: Gent
country: Belgium
facility: 1237.11.32001 Boehringer Ingelheim Investigational Site
city: Kyjov
country: Czech Republic
facility: 1237.11.42003 Boehringer Ingelheim Investigational Site
city: Rokycany
country: Czech Republic
facility: 1237.11.42004 Boehringer Ingelheim Investigational Site
city: Tabor
country: Czech Republic
facility: 1237.11.42002 Boehringer Ingelheim Investigational Site
city: Trebic
country: Czech Republic
facility: 1237.11.42001 Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: 1237.11.45002 Boehringer Ingelheim Investigational Site
city: Kolding
country: Denmark
facility: 1237.11.45004 Boehringer Ingelheim Investigational Site
city: Odense C
country: Denmark
facility: 1237.11.45001 Boehringer Ingelheim Investigational Site
city: Silkeborg
country: Denmark
facility: 1237.11.45003 Boehringer Ingelheim Investigational Site
city: Großhansdorf
country: Germany
facility: 1237.11.49003 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1237.11.49005 Boehringer Ingelheim Investigational Site
city: Mannheim
country: Germany
facility: 1237.11.49001 Boehringer Ingelheim Investigational Site
city: Mönchengladbach
country: Germany
facility: 1237.11.49004 Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: 1237.11.49002 Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: 1237.11.36001 Boehringer Ingelheim Investigational Site
city: Pecs
country: Hungary
facility: 1237.11.36004 Boehringer Ingelheim Investigational Site
city: Szeged
country: Hungary
facility: 1237.11.36003 Boehringer Ingelheim Investigational Site
city: Szombathely
country: Hungary
facility: 1237.11.36002 Boehringer Ingelheim Investigational Site
city: Almelo
country: Netherlands
facility: 1237.11.31005 Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: 1237.11.31002 Boehringer Ingelheim Investigational Site
city: Eindhoven
country: Netherlands
facility: 1237.11.31006 Boehringer Ingelheim Investigational Site
city: Heerlen
country: Netherlands
facility: 1237.11.31001 Boehringer Ingelheim Investigational Site
city: Hoorn
country: Netherlands
facility: 1237.11.31007 Boehringer Ingelheim Investigational Site
city: Zutphen
country: Netherlands
facility: 1237.11.31003 Boehringer Ingelheim Investigational Site
city: Alicante
country: Spain
facility: 1237.11.34003 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1237.11.34001 Boehringer Ingelheim Investigational Site
city: Pozuelo de Alarcón
country: Spain
facility: 1237.11.34002 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 1237.11.46001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: