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Tiotropium (18mcg) in Chronic Obstructive Pulmonary Disease (COPD) Patients With a Respiratory Infection

3 czerwca 2014 zaktualizowane przez: Boehringer Ingelheim

A 12-week, Randomised, Placebo-controlled, Double-blind, Parallel Group, Multi-center Trial to Assess the Efficacy and Safety of Tiotropium Bromide (18 µg) Delivered Via the HandiHaler® in Patients With Newly Diagnosed and/or Maintenance Treatment naïve Chronic Obstructive Pulmonary Disease (COPD) Experiencing an Acute Respiratory Infection (TICARI 1: Tiotropium In COPD Patients With an Acute Respiratory Infection 1)

The aim of the study is to investigate whether the early introduction of maintenance bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on the recovery of symptoms. It also represents an opportunity to identify COPD patients earlier in their disease state and start maintenance therapy, if appropriate.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

140

Faza

  • Faza 4

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Stany Zjednoczone
    • Arizona
      • Tucson, Arizona, Stany Zjednoczone
        • 205.479.01017 Boehringer Ingelheim Investigational Site
    • California
      • Riverside, California, Stany Zjednoczone
        • 205.479.01036 Boehringer Ingelheim Investigational Site
      • San Diego, California, Stany Zjednoczone
        • 205.479.01024 Boehringer Ingelheim Investigational Site
    • Florida
      • DeLand, Florida, Stany Zjednoczone
        • 205.479.01043 Boehringer Ingelheim Investigational Site
      • St. Petersburg, Florida, Stany Zjednoczone
        • 205.479.01040 Boehringer Ingelheim Investigational Site
    • Michigan
      • Chelsea, Michigan, Stany Zjednoczone
        • 205.479.01022 Boehringer Ingelheim Investigational Site
    • Mississippi
      • Picayune, Mississippi, Stany Zjednoczone
        • 205.479.01041 Boehringer Ingelheim Investigational Site
    • Missouri
      • St. Louis, Missouri, Stany Zjednoczone
        • 205.479.01037 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Tabor City, North Carolina, Stany Zjednoczone
        • 205.479.01005 Boehringer Ingelheim Investigational Site
      • Wilmington, North Carolina, Stany Zjednoczone
        • 205.479.01008 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone
        • 205.479.01003 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stany Zjednoczone
        • 205.479.01002 Boehringer Ingelheim Investigational Site
      • Tipton, Pennsylvania, Stany Zjednoczone
        • 205.479.01044 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, Stany Zjednoczone
        • 205.479.01006 Boehringer Ingelheim Investigational Site
      • Columbia, South Carolina, Stany Zjednoczone
        • 205.479.01001 Boehringer Ingelheim Investigational Site
      • Easley, South Carolina, Stany Zjednoczone
        • 205.479.01007 Boehringer Ingelheim Investigational Site
      • Fort Mill, South Carolina, Stany Zjednoczone
        • 205.479.01026 Boehringer Ingelheim Investigational Site
      • Gaffney, South Carolina, Stany Zjednoczone
        • 205.479.01031 Boehringer Ingelheim Investigational Site
      • Greenville, South Carolina, Stany Zjednoczone
        • 205.479.01012 Boehringer Ingelheim Investigational Site
      • Hodges, South Carolina, Stany Zjednoczone
        • 205.479.01048 Boehringer Ingelheim Investigational Site
      • Spartanburg, South Carolina, Stany Zjednoczone
        • 205.479.01004 Boehringer Ingelheim Investigational Site
      • Union, South Carolina, Stany Zjednoczone
        • 205.479.01019 Boehringer Ingelheim Investigational Site
    • South Dakota
      • Rapid City, South Dakota, Stany Zjednoczone
        • 205.479.01039 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, Stany Zjednoczone
        • 205.479.01033 Boehringer Ingelheim Investigational Site
    • Texas
      • Killeen, Texas, Stany Zjednoczone
        • 205.479.01028 Boehringer Ingelheim Investigational Site
    • Virginia
      • Ettrick, Virginia, Stany Zjednoczone
        • 205.479.01038 Boehringer Ingelheim Investigational Site
      • Norfolk, Virginia, Stany Zjednoczone
        • 205.479.01047 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 i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion criteria:

  1. All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial and conducting any study procedures.
  2. Male or female patients 40 years of age or older.
  3. Ability to independently read and understand English and/or Spanish.
  4. Any self-reported history of smoking (e.g. = 100 cigarettes (~5 packs) during life-time).
  5. Acute respiratory symptoms for up to 7 days
  6. All patients must have a diagnosis of COPD, and must have an airway obstruction with a post-bronchodilator (Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC)) <0.7. The diagnosis of COPD can be made at Visit 1.
  7. The clinical assessment of the enrolled patient in the judgement of the investigator supports the introduction of COPD maintenance therapy.
  8. Patients must be able to inhale medication in a competent manner from the HandiHaler® device and from a metered dose inhaler (MDI)

Exclusion criteria:

  1. Therapy with any long-acting bronchodilator, short-acting anticholinergic, inhaled corticosteroid or regular maintenance use (>14 consecutive days) of systemic corticosteroid (the latter for respiratory indications) during the previous 6 months (short course of systemic corticosteroid for up to 14 days for respiratory indications allowed); in case of use of systemic corticosteroid medication for other than respiratory conditions, then exclusion of unstable doses (i.e., less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone-equivalent per day. In addition, daily use of short-acting beta2-agonist for more than a week prior to Visit 0 not allowed.

    The following exclusion criteria apply at Visit 1:

  2. Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patient¿s ability to participate in the study.
  3. A recent history (i.e., six months or less) of myocardial infarction. Patients being stable with a history of cardiac stents prior to six month are permitted.
  4. Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
  5. Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.
  6. Any significant or new ECG findings at V1 as judged by the investigator, including, but not limited to signs of ischemia, arrhythmia, heart failure, or the report of chest pain.
  7. Known active tuberculosis.
  8. Current asthma (patient treated for asthma in the last 2 years), cystic fibrosis, clinical diagnosis of bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
  9. A history of thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion no. 2.
  10. Malignancy for which the patient has undergone resection, radiation, chemotherapy or biological treatments within the last year or is currently on active radiation therapy, chemotherapy or biological treatment. Patients with treated basal cell carcinoma are allowed.
  11. At visit 0 or 1, a severe respiratory infection, e.g. pneumonia (as suspected by investigator), any condition or exacerbation requiring ER visit or hospitalization, need for oxygen treatment.
  12. Known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler® or MDI inhalation solution delivery system.
  13. Treatment with any restricted pulmonary medication
  14. Requirement of supplemental oxygen therapy for = 24 hours during the previous 6 months.
  15. Known moderate to severe renal impairment.
  16. Known narrow angle glaucoma.
  17. Significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.
  18. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g., Norplant®) for at least three months prior to and for the duration of the trial.
  19. Significant alcohol or drug abuse within the past 12 months.
  20. Actively participating in a pulmonary rehabilitation program.
  21. Previously randomized in this study or currently participating in another interventional study.
  22. Visual impairment that as judged by the investigator does not allow the patient to independently read and complete the questionnaires and electronic diary (eDiary).

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: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
placebo
Lek: Placebo
placebo
Eksperymentalny: tiotropium 18mcg
active
Lek: tiotropium
18mcg

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Trough FEV1 After 12 Weeks on Study Drug
Ramy czasowe: 12 weeks
The primary endpoint was trough forced expiratory volume in 1 second (FEV1) after 12 weeks on study drug. Trough forced expiratory volume in 1 second (FEV1)was defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.
12 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Time to Recovery From Acute Respiratory Symptoms
Ramy czasowe: 12 weeks

Time to recovery was assessed with the EXACT-PRO questionnaire tool. The EXACT-PRO was designed to collect data to quantify frequency, severity, and duration of exacerbations in patients with COPD including the onset of and the recovery from COPD exacerbations.

The EXACT-PRO is a 14-item questionnaire. Each attribute or item was assessed on a five- or six-point ordinal scale and summed to yield a total score that was converted to a 0-100 scale, with higher scores indicating a more severe health state or exacerbation.

The EXACT-PRO was answered by the patients on a daily basis in the evening.
12 weeks
Trough FVC (in Litres) at 12 Weeks
Ramy czasowe: 12 weeks
The trough Forced Vital Capacity (FVC) was defined as the FVC measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.
12 weeks
Responder Status at Week 4 Clinic Visit
Ramy czasowe: 4 weeks

Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented:

  • Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included).
  • Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1).
  • Subject did not recover.
4 weeks
Responder Status at Week 12 Clinic Visit
Ramy czasowe: 12 weeks

Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented:

  • Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included).
  • Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1).
  • Subject did not recover.
12 weeks
Weekly Rescue Medication Use Over the 12 Weeks of Study
Ramy czasowe: 12 weeks
Daily rescue albuterol use was recorded in the diary in response to the following question: How many puffs of rescue medication did you use during the last 24 hours? The weekly rescue medication use was derived by summing the daily uses over the 12 weeks and dividing this total by 12 weeks.
12 weeks

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.

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 listopada 2011

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2012

Ukończenie studiów (Rzeczywisty)

1 grudnia 2012

Daty rejestracji na studia

Pierwszy przesłany

30 listopada 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 listopada 2011

Pierwszy wysłany (Oszacować)

1 grudnia 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

9 czerwca 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 czerwca 2014

Ostatnia weryfikacja

1 marca 2014

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 205.479

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 .

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