Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01431287
First received: September 8, 2011
Last updated: March 28, 2014
Last verified: March 2014

September 8, 2011
March 28, 2014
September 2011
November 2013   (final data collection date for primary outcome measure)
  • FEV1 AUC0-3h response [L] on Day 169 [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • Trough FEV1 response [L] on Day 170 [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • SGRQ total score on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FEv1 AUC0-3h response [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • Trough FEV1 response [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • SGRQ total score (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01431287 on ClinicalTrials.gov Archive Site
  • TDI focal score on Day 169 (Key secondary endpoint; This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC0-3h response [L] on Day 1, Day 85 and Day 365 [ Time Frame: 52 weeks treatment ] [ Designated as safety issue: No ]
  • Trough FEV1 response [L] on Day 15, Day 43, Day 85, Day 169 and Day 365 [ Time Frame: 52 weeks treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC0-12h response [L] in sub-set of patients with 12-hour PFTs on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FVC AUC0-12h response [L] in sub-set of patients with 12-hour PFTs on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC0-24h response [L] in sub-set of patients with 12-hour PFTs on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • FVC AUC0-3h response [L] on Day 1, Day 85 and Day 365 [ Time Frame: 52 weeks treatment ] [ Designated as safety issue: No ]
  • Trough FVC response [L] on Day 15, Day 43, Day 85, Day 170 and Day 365 [ Time Frame: 52 weeks treatment ] [ Designated as safety issue: No ]
  • FVC AUC0-24h response [L] in sub-set of patients with 12-hour PFTs on Day 169 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • SGRQ total score on Day 85 and Day 365 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • TDI focal score on Day 43, Day 85 and Day 365 (This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • TDI focal score (Key secondary endpoint; This endpoint will be evaluated after combining the data from this and the replicate study 1237.5) [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FVC AUC0-3h response [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • Trough FVC response [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FEV1 AUC0-12h response [L] in sub-set of patients with 12-hour PFTs [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FEV1 peak0-3 response [L] [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FEV1 response [L] at 5, 15 and 30 minutes, and at 1, 2 and 3 hours after inhalation of study medication [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FVCresponse [L] at 5, 15 and 30 minutes, and at 1, 2 and 3 hours after inhalation of study medication [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FVC peak0-3 response [L] [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
  • FVC AUC0-12h response [L] in sub-set of patients with 12-hour PFTs [ Time Frame: 24 weeks treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)
A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2]

The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: tiotropium + olodaterol
    fixed dose combination
  • Drug: tiotropium
    low dose or high dose
  • Drug: olodaterol
    one dose only
  • Experimental: tiotropium+olodaterol high dose FDC
    Once daily 2 puffs solution for inhalation Respimat
    Intervention: Drug: tiotropium + olodaterol
  • Experimental: tiotropium+olodaterol low dose FDC
    Once daily 2 puffs solution for inhalation Respimat
    Intervention: Drug: tiotropium + olodaterol
  • Active Comparator: olodaterol
    Once daily 2 puffs solution for inhalation Respimat
    Intervention: Drug: olodaterol
  • Active Comparator: tiotropium low dose
    Once daily 2 puffs solution for inhalation Respimat
    Intervention: Drug: tiotropium
  • Active Comparator: tiotropium high dose
    Once daily 2 puffs solution for inhalation Respimat
    Intervention: Drug: tiotropium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2539
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Diagnosis of chronic obstructive pulmonary disease.
  2. Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%.
  3. Male or female patients, 40 years of age or older.
  4. Smoking history of more than 10 pack years.

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 within 1 year of screening visit
  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. Thoracotomy with pulmonary resection
  16. Oral ß-adrenergics.
  17. Oral corticosteroid medication at unstable doses
  18. Regular use of 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, anticholinergics, BAC, EDTA
  22. Pregnant or nursing women.
  23. Women of childbearing potential not using a highly effective method of birth control
  24. Patients who are unable to comply with pulmonary medication restrictions
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Russian Federation,   South Africa,   Belgium,   Spain,   Ireland,   Hungary,   Serbia,   Croatia,   Romania,   Slovakia,   Austria,   United Kingdom,   Sweden,   Norway,   Germany,   Brazil,   Colombia,   Japan,   China,   Taiwan,   Turkey,   India
 
NCT01431287
1237.6, 2009-010669-22
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP