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Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients

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ClinicalTrials.gov Identifier: NCT01969721
Recruitment Status : Completed
First Posted : October 25, 2013
Results First Posted : February 12, 2016
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: fluticasone propionate Drug: salmeterol Drug: placebo Drug: tiotropium Drug: olodaterol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : October 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Arm Intervention/treatment
Experimental: T+O FDC dosage 1
Low dose
Drug: olodaterol
Drug: placebo
placebo/dummy for blinding purposes

Drug: tiotropium
tiotropium low dose

Experimental: T+O FDC dosage 2
High dose
Drug: placebo
placebo/dummy for blinding purposes

Drug: tiotropium
tiotropium high dose

Drug: olodaterol
Active Comparator: ICS/LABA FDC Dosage 1
Low dose
Drug: fluticasone propionate
low dose

Drug: salmeterol
Drug: placebo
placebo/dummy for blinding purposes

Active Comparator: ICS/LABA FDC Dosage 2
High dose
Drug: placebo
placebo/dummy for blinding purposes

Drug: fluticasone propionate
low dose

Drug: salmeterol



Primary Outcome Measures :
  1. FEV1 AUC (0−12h) Change From Patient Baseline After 6 Weeks of Treatment [ Time Frame: Baseline and 6 weeks. ]

    Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.

    The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.



Secondary Outcome Measures :
  1. FEV1 AUC (0−24h) Change From Patient Baseline After 6 Weeks of Treatment [ Time Frame: Baseline and 6 weeks. ]

    Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 24 hours post-dose (AUC 0-24h) [L] after 6 weeks of treatment.

    Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.


  2. Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment [ Time Frame: Baseline and 6 weeks. ]

    Change from patient baseline in Trough Forced Expiratory Volume in one second (FEV1) after 6 weeks of treatment. Trough FEV1 was defined as the mean of the 23h and 23h 50min (minutes) post-dose FEV1 measurements. Measured values presented are actually adjusted means.

    The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.


  3. FEV1 AUC (12−24h) Change From Patient Baseline After 6 Weeks of Treatment [ Time Frame: Baseline and 6 weeks. ]

    Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 12 to 24 hours post-dose (AUC 12-24h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.

    The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient.


  4. FEV1 Peak (0−3h) Change From Patient Baseline After 6 Weeks of Treatment [ Time Frame: Baseline and 6 weeks. ]
    Change from patient baseline in Forced Expiratory Volume in one second (FEV1) peak (0-3 hours) after 6 weeks of treatment. FEV1 peak (0-3 hours) was defined as the maximum FEV1 value measured within the first three hours post dosing. Measured values presented are actually adjusted means.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969721


Locations
Show Show 29 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01969721    
Other Study ID Numbers: 1237.11
2013-000808-41 ( EudraCT Number: EudraCT )
First Posted: October 25, 2013    Key Record Dates
Results First Posted: February 12, 2016
Last Update Posted: February 12, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Tiotropium Bromide
Olodaterol
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Fluticasone
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents