Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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 listopada 2016 zaktualizowane przez: 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

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

304

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Australia
    • South Australia
      • Daw Park, South Australia, Australia
        • Boehringer Ingelheim Investigational Site
      • Glen Osmond, South Australia, Australia
        • Boehringer Ingelheim Investigational Site
  • Austria
      • Salzburg, Austria
        • Boehringer Ingelheim Investigational Site
  • Belgia
      • Genk, Belgia
        • Boehringer Ingelheim Investigational Site
      • Hasselt, Belgia
        • Boehringer Ingelheim Investigational Site
      • Leuven, Belgia
        • Boehringer Ingelheim Investigational Site
  • Dania
      • Kolding, Dania
        • Boehringer Ingelheim Investigational Site
      • København NV, Dania
        • Boehringer Ingelheim Investigational Site
      • Odense, Dania
        • 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
  • Niemcy
      • Berlin, Niemcy
        • Boehringer Ingelheim Investigational Site
      • Bochum, Niemcy
        • Boehringer Ingelheim Investigational Site
      • Frankfurt, Niemcy
        • Boehringer Ingelheim Investigational Site
      • Großhansdorf, Niemcy
        • Boehringer Ingelheim Investigational Site
      • Heidelberg, Niemcy
        • Boehringer Ingelheim Investigational Site
      • Leverkusen, Niemcy
        • Boehringer Ingelheim Investigational Site
      • Solingen, Niemcy
        • Boehringer Ingelheim Investigational Site
      • Teuchern, Niemcy
        • Boehringer Ingelheim Investigational Site
      • Tübingen, Niemcy
        • Boehringer Ingelheim Investigational Site
  • Nowa Zelandia
      • Greenlane East Auckland NZ, Nowa Zelandia
        • Boehringer Ingelheim Investigational Site
  • Polska
      • Gdansk, Polska
        • Boehringer Ingelheim Investigational Site
      • Lodz, Polska
        • Boehringer Ingelheim Investigational Site
      • Starachowice, Polska
        • Boehringer Ingelheim Investigational Site
  • Portugalia
      • Coimbra, Portugalia
        • Boehringer Ingelheim Investigational Site
      • Lisboa, Portugalia
        • Boehringer Ingelheim Investigational Site
      • Porto, Portugalia
        • Boehringer Ingelheim Investigational Site
  • Stany Zjednoczone
    • California
      • San Diego, California, Stany Zjednoczone
        • Boehringer Ingelheim Investigational Site
      • Torrance, California, Stany Zjednoczone
        • Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford, Connecticut, Stany Zjednoczone
        • Boehringer Ingelheim Investigational Site
  • Zjednoczone Królestwo
      • Leicester, Zjednoczone Królestwo
        • Boehringer Ingelheim Investigational Site
      • Norwich, Zjednoczone Królestwo
        • Boehringer Ingelheim Investigational Site
      • Sheffield, Zjednoczone Królestwo
        • Boehringer Ingelheim Investigational Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: placebo
patient will receive placebo once daily, 2 puffs in the morning
Lek: placebo to tiotropium + olodaterol
comparator
Eksperymentalny: 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
Lek: tiotropium +olodaterol
olodaterol 5 mcg once daily fixed dose combination
Aktywny komparator: tiotropium
patient will receive tiotropium 5 mcg once daily, 2 puffs in the morning
Lek: tiotropium
tiotropium 5 mcg once daily fixed dose combination
Eksperymentalny: 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
Lek: tiotropium+olodaterol
tiotropium 5 mcg once daily

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Week 8
Resting inspiratory capacity (IC) measured at 1.5 hours post dose after 8 weeks of treatment.
Week 8

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Boehringer Ingelheim

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 marca 2014

Zakończenie podstawowe (Rzeczywisty)

1 sierpnia 2015

Ukończenie studiów (Rzeczywisty)

1 października 2015

Daty rejestracji na studia

Pierwszy przesłany

7 marca 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 marca 2014

Pierwszy wysłany (Oszacować)

12 marca 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

6 stycznia 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 listopada 2016

Ostatnia weryfikacja

1 listopada 2016

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Choroba płuc, przewlekła obturacja

Badania kliniczne na placebo to tiotropium + olodaterol

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Singapore

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj