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To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways

9. November 2016 aktualisiert von: Boehringer Ingelheim

An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat® Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

304

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Australien
    • South Australia
      • Daw Park, South Australia, Australien
        • Boehringer Ingelheim Investigational Site
      • Glen Osmond, South Australia, Australien
        • Boehringer Ingelheim Investigational Site
  • Belgien
      • Genk, Belgien
        • Boehringer Ingelheim Investigational Site
      • Hasselt, Belgien
        • Boehringer Ingelheim Investigational Site
      • Leuven, Belgien
        • Boehringer Ingelheim Investigational Site
  • Deutschland
      • Berlin, Deutschland
        • Boehringer Ingelheim Investigational Site
      • Bochum, Deutschland
        • Boehringer Ingelheim Investigational Site
      • Frankfurt, Deutschland
        • Boehringer Ingelheim Investigational Site
      • Großhansdorf, Deutschland
        • Boehringer Ingelheim Investigational Site
      • Heidelberg, Deutschland
        • Boehringer Ingelheim Investigational Site
      • Leverkusen, Deutschland
        • Boehringer Ingelheim Investigational Site
      • Solingen, Deutschland
        • Boehringer Ingelheim Investigational Site
      • Teuchern, Deutschland
        • Boehringer Ingelheim Investigational Site
      • Tübingen, Deutschland
        • Boehringer Ingelheim Investigational Site
  • Dänemark
      • Kolding, Dänemark
        • Boehringer Ingelheim Investigational Site
      • København NV, Dänemark
        • Boehringer Ingelheim Investigational Site
      • Odense, Dänemark
        • Boehringer Ingelheim Investigational Site
  • Kanada
    • Quebec
      • Montreal, Quebec, Kanada
        • Boehringer Ingelheim Investigational Site
      • Ste-Foy, Quebec, Kanada
        • Boehringer Ingelheim Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada
        • Boehringer Ingelheim Investigational Site
  • Neuseeland
      • Greenlane East Auckland NZ, Neuseeland
        • Boehringer Ingelheim Investigational Site
  • Polen
      • Gdansk, Polen
        • Boehringer Ingelheim Investigational Site
      • Lodz, Polen
        • Boehringer Ingelheim Investigational Site
      • Starachowice, Polen
        • Boehringer Ingelheim Investigational Site
  • Portugal
      • Coimbra, Portugal
        • Boehringer Ingelheim Investigational Site
      • Lisboa, Portugal
        • Boehringer Ingelheim Investigational Site
      • Porto, Portugal
        • Boehringer Ingelheim Investigational Site
  • Vereinigte Staaten
    • California
      • San Diego, California, Vereinigte Staaten
        • Boehringer Ingelheim Investigational Site
      • Torrance, California, Vereinigte Staaten
        • Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford, Connecticut, Vereinigte Staaten
        • Boehringer Ingelheim Investigational Site
  • Vereinigtes Königreich
      • Leicester, Vereinigtes Königreich
        • Boehringer Ingelheim Investigational Site
      • Norwich, Vereinigtes Königreich
        • Boehringer Ingelheim Investigational Site
      • Sheffield, Vereinigtes Königreich
        • Boehringer Ingelheim Investigational Site
  • Österreich
      • Salzburg, Österreich
        • Boehringer Ingelheim Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion criteria:

  • All patients must sign an informed consent consistent with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
  • All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator forced expiratory volume in one second >=30% and <80% of predicted normal; Global Initiative for Chronic Obstructive Lung Disease grade II - III, and a post-bronchodilator Tiffeneau index <70% at Visit 1.
  • Male or female patients, aged >=40 years and <=75 years.
  • Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.

Exclusion criteria:

  • Patients with a significant disease other than chronic obstructive pulmonary disease.
  • Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis.
  • Patients with a history of asthma.
  • A diagnosis of thyrotoxicosis.
  • A diagnosis of paroxysmal tachycardia (>100 beats per minute).
  • A history of myocardial infarction within 1 year of screening visit.
  • Unstable or life-threatening cardiac arrhythmia.
  • Hospitalized for heart failure within the past year.
  • Known active tuberculosis.
  • A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years.
  • A history of life-threatening pulmonary obstruction and patients with chronic respiratory failure.
  • A history of cystic fibrosis.
  • Clinically evident bronchiectasis.
  • A history of significant alcohol or drug abuse.
  • Any contraindications for exercise testing.
  • Patients who have undergone thoracotomy with pulmonary resection.
  • Patients being treated with any oral ß-adrenergics.
  • Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
  • Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigators opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
  • Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.
  • Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity.
  • Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit.
  • Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, benzalkonium chloride, disodium edentat, or any other component of the Respimat® inhalation solution delivery system.
  • Pregnant or nursing women.
  • Women of childbearing potential not using highly effective methods of birth control.
  • Patients who have previously been randomized in this study or are currently participating in another study.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: placebo
patient will receive placebo once daily, 2 puffs in the morning
Arzneimittel: placebo to tiotropium + olodaterol
comparator
Experimental: tiotropium + olodaterol high dose with BM
patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning
Arzneimittel: tiotropium +olodaterol
olodaterol 5 mcg once daily fixed dose combination
Aktiver Komparator: tiotropium
patient will receive tiotropium 5 mcg once daily, 2 puffs in the morning
Arzneimittel: tiotropium
tiotropium 5 mcg once daily fixed dose combination
Experimental: tiotropium + olodaterol with exercise training and BM
patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning
Arzneimittel: tiotropium+olodaterol
tiotropium 5 mcg once daily

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks
Zeitfenster: Week 8
Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.
Week 8

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12
Zeitfenster: Week 12
Average daily walking time measured by the activity monitor in the week prior to Week 12.
Week 12
Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment
Zeitfenster: Week 12
Average daily walking intensity measured by the activity monitor in the week prior to 12 weeks of treatment. The Movement Intensity (MI) is derived from the acceleration signals. Since seismic sensors measure gravitational acceleration (g) in static situations, the acceleration signal is expressed relative to g (1g = 9.81m/s2). To calculate movement intensity (MI) the gravitational acceleration in static situations was removed and the rotation vector of the three accelerometer signals was calculated. The MI gives an indication of the power of movements.
Week 12
Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12
Zeitfenster: Week 12
Perceived difficulties as evaluated with FPI-SF. FPI-SF self-report questionnaire has 6 domains: Body care(5 items), Household maintenance(8 items), Physical exercise(5 items), Recreation(5 items), Spiritual activities(4 items) and Social interaction(5 items) with five possible answers on each item: Do with no difficulty - 3, Do with some difficulty - 2, Do with great difficulty - 1, don't do because of health reasons - 0, and don't do because choose not to - 0. Domain scores are expressed as mean values, with at least 6 non-missing items required for the household maintenance domain and at least 3 non-missing items for the other domains. Total score is the mean across the six domains. So total and domain scores range from 0 to 3, with higher scores indicating higher levels of functional activity within and across domains. Respondents engaged in many activities with no difficulty will score high on the FPI, while those who perform few activities with much difficulty will score low.
Week 12
Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks
Zeitfenster: Week 12
Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of maximum oxygen consumption (VO2 peak) after 12 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then the ANCOVA was fitted to the log10-transformed data and the least square means and SE were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.
Week 12
One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment
Zeitfenster: Week 8
One hour, Post-dose Forced Expiratory Volume in One Second (FEV1) after 8 weeks of treatment.
Week 8
One Hour, Post-dose Forced Vital Capacity (FVC) After 8 Weeks of Treatment
Zeitfenster: Week 8
One hour, Post-dose Forced Vital Capacity (FVC) after 8 weeks of treatment.
Week 8
Resting Inspiratory Capacity (IC) Measured at 1.5 Hours Post Dose After 8 Weeks of Treatment
Zeitfenster: Week 8
Resting inspiratory capacity (IC) measured at 1.5 hours post dose after 8 weeks of treatment.
Week 8

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boehringer Ingelheim

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2014

Primärer Abschluss (Tatsächlich)

1. August 2015

Studienabschluss (Tatsächlich)

1. Oktober 2015

Studienanmeldedaten

Zuerst eingereicht

7. März 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. März 2014

Zuerst gepostet (Schätzen)

12. März 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

6. Januar 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. November 2016

Zuletzt verifiziert

1. November 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1237.16
  • 2013-002671-18 (EudraCT-Nummer: EudraCT)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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