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OpenTrials
Completed

NCT Number: NCT01969721

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1237.11.32002 Boehringer Ingelheim Investigational Site, Genk, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of chronic obstructive pulmonary disease
  • 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%
  • Male or female patients, 40 years of age or older
  • Smoking history of more than 10 pack years
  • Ability to perform technically acceptable pulmonary function tests and maintain records
  • Ability to inhale medication in a competent manner from the RESPIMAT Inhaler, Accuhaler and from a metered dose inhaler (MDI)

Exclusion criteria

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

Treatment and study plan

Fluticasone propionate

Drug

low dose

Salmeterol

Drug

Placebo

Drug

placebo/dummy for blinding purposes

Tiotropium

Drug

tiotropium high dose

Olodaterol

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 25, 2013
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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