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Completed

NCT Number: NCT01559116

Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease

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.

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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

1237.20.32203 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 FEV1< 80% of predicted normal and a post-bronchodilator FEV1/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 and from a metered dose inhaler (MDI)

Exclusion criteria

  • significant disease other than COPD
  • 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 at unstable doses
  • 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
  • Women of childbearing potential not using a highly effective method of birth control
  • Patients who have previously been randomised in this study or are currently participating in another study
  • Patients who are unable to comply with pulmonary medication restrictions prior to randomisation

Treatment and study plan

tiotropium + olodaterol

Drug

low dose + one dose only

Tiotropium

Drug

low dose

Olodaterol

Drug

one dose only

Placebo

Drug

placebo matching tiotropium+olodaterol FDC

Respimat

Device

Respimat inhaler

Primary outcomes

  1. Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment.

    Time frame: day 1 and week 6

    Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 24 h post-dose, using the trapezoidal rule, divided by the duration (24 h) to report in litres.

    Mean is actually the Adjusted mean.

    The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

Secondary outcomes

  1. FEV1 AUC0-12h Response [L] After 6 Weeks Treatment.

    Time frame: day 1 and week 6

    Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 12 h post-dose, using the trapezoidal rule, divided by the duration (12h) to report in litres.

    Mean is actually the Adjusted mean.

    The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

  2. FEV1 AUC12-24h Response [L] After 6 Weeks Treatment.

    Time frame: day 1 and week 6

    Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.

    Mean is actually the Adjusted mean.

    The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

  3. Trough FEV1 Response [L] After 6 Weeks Treatment.

    Time frame: day 1 and week 6

    Trough Forced Expiratory Volume in 1 second (FEV1) response after 6 weeks treatment period.

    The trough was defined as the mean of the 23 h and 23 h50 min measurements and Response was defined as the change from patient baseline.

    Mean is actually the Adjusted mean.

    The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

  4. Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment.

    Time frame: day 1 and week 6

    Peak (0-3h) Forced Expiratory Volume in 1 second (FEV1) response.

    The peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.

    Mean is actually the Adjusted mean.

    The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

  5. FVC AUC0-24h Response [L] After 6 Weeks Treatment.

    Time frame: day 1 and week 6

    Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.

    Mean is actually the Adjusted mean.

    The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

  6. FVC AUC0-12h Response [L] After 6 Weeks Treatment.

    Time frame: day 1 and week 6

    Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.

    Mean is actually the Adjusted mean.

    The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

  7. FVC AUC12-24h Response [L] After 6 Weeks Treatment.

    Time frame: day 1 and week 6

    Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.

    Mean is actually the Adjusted mean.

    The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

  8. Trough FVC Response [L] After 6 Weeks Treatment.

    Time frame: day1 and week 6

    Trough Forced Vital Capacity (FVC) response after 6 weeks treatment period.

    The trough was defined as the mean of the 23 h and 23 h50 min measurements and response was defined as the change from patient baseline.

    Mean is actually the Adjusted mean.

    The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

  9. Peak (0-3h) FVC Response [L] After 6 Weeks Treatment.

    Time frame: day 1 and week 6

    Peak (0-3h) Forced Vital Capacity (FVC) responses after 6 weeks treatment.

    Peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.

    Mean is actually the Adjusted mean.

    The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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]

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 21, 2012
Registry last updated
Jul 16, 2015

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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