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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. listopadu 2016 aktualizováno: 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

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

304

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Austrálie
    • South Australia
      • Daw Park, South Australia, Austrálie
        • Boehringer Ingelheim Investigational Site
      • Glen Osmond, South Australia, Austrálie
        • Boehringer Ingelheim Investigational Site
  • Belgie
      • Genk, Belgie
        • Boehringer Ingelheim Investigational Site
      • Hasselt, Belgie
        • Boehringer Ingelheim Investigational Site
      • Leuven, Belgie
        • Boehringer Ingelheim Investigational Site
  • Dánsko
      • Kolding, Dánsko
        • Boehringer Ingelheim Investigational Site
      • København NV, Dánsko
        • Boehringer Ingelheim Investigational Site
      • Odense, Dánsko
        • 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
  • Nový Zéland
      • Greenlane East Auckland NZ, Nový Zéland
        • Boehringer Ingelheim Investigational Site
  • Německo
      • Berlin, Německo
        • Boehringer Ingelheim Investigational Site
      • Bochum, Německo
        • Boehringer Ingelheim Investigational Site
      • Frankfurt, Německo
        • Boehringer Ingelheim Investigational Site
      • Großhansdorf, Německo
        • Boehringer Ingelheim Investigational Site
      • Heidelberg, Německo
        • Boehringer Ingelheim Investigational Site
      • Leverkusen, Německo
        • Boehringer Ingelheim Investigational Site
      • Solingen, Německo
        • Boehringer Ingelheim Investigational Site
      • Teuchern, Německo
        • Boehringer Ingelheim Investigational Site
      • Tübingen, Německo
        • Boehringer Ingelheim Investigational Site
  • Polsko
      • Gdansk, Polsko
        • Boehringer Ingelheim Investigational Site
      • Lodz, Polsko
        • Boehringer Ingelheim Investigational Site
      • Starachowice, Polsko
        • Boehringer Ingelheim Investigational Site
  • Portugalsko
      • Coimbra, Portugalsko
        • Boehringer Ingelheim Investigational Site
      • Lisboa, Portugalsko
        • Boehringer Ingelheim Investigational Site
      • Porto, Portugalsko
        • Boehringer Ingelheim Investigational Site
  • Rakousko
      • Salzburg, Rakousko
        • Boehringer Ingelheim Investigational Site
  • Spojené království
      • Leicester, Spojené království
        • Boehringer Ingelheim Investigational Site
      • Norwich, Spojené království
        • Boehringer Ingelheim Investigational Site
      • Sheffield, Spojené království
        • Boehringer Ingelheim Investigational Site
  • Spojené státy
    • California
      • San Diego, California, Spojené státy
        • Boehringer Ingelheim Investigational Site
      • Torrance, California, Spojené státy
        • Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford, Connecticut, Spojené státy
        • Boehringer Ingelheim Investigational Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

40 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: placebo
patient will receive placebo once daily, 2 puffs in the morning
Lék: placebo to tiotropium + olodaterol
comparator
Experimentální: 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
Lék: tiotropium +olodaterol
olodaterol 5 mcg once daily fixed dose combination
Aktivní komparátor: tiotropium
patient will receive tiotropium 5 mcg once daily, 2 puffs in the morning
Lék: tiotropium
tiotropium 5 mcg once daily fixed dose combination
Experimentální: 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
Lék: tiotropium+olodaterol
tiotropium 5 mcg once daily

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Week 8
Resting inspiratory capacity (IC) measured at 1.5 hours post dose after 8 weeks of treatment.
Week 8

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Boehringer Ingelheim

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. března 2014

Primární dokončení (Aktuální)

1. srpna 2015

Dokončení studie (Aktuální)

1. října 2015

Termíny zápisu do studia

První předloženo

7. března 2014

První předloženo, které splnilo kritéria kontroly kvality

7. března 2014

První zveřejněno (Odhad)

12. března 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

6. ledna 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. listopadu 2016

Naposledy ověřeno

1. listopadu 2016

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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