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Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics

28 maja 2015 zaktualizowane przez: Teva Branded Pharmaceutical Products R&D, Inc.

A 12-week Comparison of the Efficacy and Safety and Steady-State Pharmacokinetics of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma

The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

160

Faza

  • Faza 3

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • Costa Mesa, California, Stany Zjednoczone
        • Teva Investigational Site 10225
      • Encinitas, California, Stany Zjednoczone
        • Teva Investigational Site 10250
      • Huntington Beach, California, Stany Zjednoczone
        • Teva Investigational Site 10230
      • Palmdale, California, Stany Zjednoczone
        • Teva Investigational Site 10255
      • Rancho Mirage, California, Stany Zjednoczone
        • Teva Investigational Site 10231
      • Riverside, California, Stany Zjednoczone
        • Teva Investigational Site 10252
      • Rolling Hills Estates, California, Stany Zjednoczone
        • Teva Investigational Site 10242
      • San Diego, California, Stany Zjednoczone
        • Teva Investigational Site 10238
      • San Jose, California, Stany Zjednoczone
        • Teva Investigational Site 10243
    • Florida
      • Miami Lakes, Florida, Stany Zjednoczone
        • Teva Investigational Site 10247
      • Tallahassee, Florida, Stany Zjednoczone
        • Teva Investigational Site 10239
      • Tampa, Florida, Stany Zjednoczone
        • Teva Investigational Site 10234
    • Maine
      • Bangor, Maine, Stany Zjednoczone
        • Teva Investigational Site 10253
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone
        • Teva Investigational Site 10257
      • White Marsh, Maryland, Stany Zjednoczone
        • Teva Investigational Site 10254
    • Massachusetts
      • Fall River, Massachusetts, Stany Zjednoczone
        • Teva Investigational Site 10235
      • North Dartmouth, Massachusetts, Stany Zjednoczone
        • Teva Investigational Site 10236
    • Minnesota
      • Minneapolis, Minnesota, Stany Zjednoczone
        • Teva Investigational Site 10226
      • Minneapolis, Minnesota, Stany Zjednoczone
        • Teva Investigational Site 10233
    • Missouri
      • St. Louis, Missouri, Stany Zjednoczone
        • Teva Investigational Site 10241
    • Nebraska
      • Bellevue, Nebraska, Stany Zjednoczone
        • Teva Investigational Site 10229
    • New York
      • Rochester, New York, Stany Zjednoczone
        • Teva Investigational Site 10227
    • North Carolina
      • Charlotte, North Carolina, Stany Zjednoczone
        • Teva Investigational Site 10244
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone
        • Teva Investigational Site 10248
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone
        • Teva Investigational Site 10249
    • Oregon
      • Eugene, Oregon, Stany Zjednoczone
        • Teva Investigational Site 10232
      • Medford, Oregon, Stany Zjednoczone
        • Teva Investigational Site 10259
      • Portland, Oregon, Stany Zjednoczone
        • Teva Investigational Site 10237
    • Pennsylvania
      • Bethlehem, Pennsylvania, Stany Zjednoczone
        • Teva Investigational Site 10240
      • Pittsburgh, Pennsylvania, Stany Zjednoczone
        • Teva Investigational Site 10246
      • Pittsburgh, Pennsylvania, Stany Zjednoczone
        • Teva Investigational Site 10256
    • South Carolina
      • Rock Hill, South Carolina, Stany Zjednoczone
        • Teva Investigational Site 10251
      • Spartanburg, South Carolina, Stany Zjednoczone
        • Teva Investigational Site 10228
    • Texas
      • San Antonio, Texas, Stany Zjednoczone
        • Teva Investigational Site 10258
    • Washington
      • Seattle, Washington, Stany Zjednoczone
        • Teva Investigational Site 10245

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

12 lat i starsze (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Written informed consent/assent
  • At least 12 years of age at screening
  • General good health
  • Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility
  • Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.
  • Ability to perform spirometry in an acceptable manner as per protocol guidelines
  • Other inclusion criteria apply

Exclusion Criteria:

  • A known hypersensitivity to albuterol or any of the excipients in the formulations.
  • History of a respiratory infection or disorder that has not resolved within 1 week preceding the Screening Visit (SV).
  • History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
  • Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
  • Hospitalization due to asthma exacerbation 2 or more times in the past year
  • Initiation of immunotherapy or dose escalation during the study period
  • Other exclusion criteria apply.

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: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo MDPI
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Lek: Placebo MDPI
Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Inne nazwy:
  • Placebo Spiromax®
Eksperymentalny: Albuterol MDPI
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Lek: Albuterol MDPI
Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Inne nazwy:
  • ProAir® RespiClick, Albuterol Spiromax®

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
Ramy czasowe: Day 1, Day 8 and Day 85

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.

FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Day 1, Day 8 and Day 85

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
Ramy czasowe: Day 1

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.

FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Day 1
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8
Ramy czasowe: Day 8

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.

FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Day 8
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85
Ramy czasowe: Day 85

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.

FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Day 85
Participants With Adverse Events
Ramy czasowe: Day 1 to Day 93
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Day 1 to Day 93
Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group
Ramy czasowe: Day 1 (Baseline), Day 85
Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint. HEENT = head, eyes, ears, nose, throat.
Day 1 (Baseline), Day 85
Participants With Clinically Significant Vital Sign Assessments
Ramy czasowe: Days 8 and 85

For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min).

Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant:

Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute
Days 8 and 85
Maximum Observed Plasma Drug Concentration (Cmax) for Albuterol on Days 1 and 8
Ramy czasowe: Days 1 and 8
Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).
Days 1 and 8
Time to Observed Peak Plasma Concentration (Tmax) for Albuterol on Days 1 and 8
Ramy czasowe: Days 1 and 8
Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).
Days 1 and 8
Area Under the Concentration-time Curve From Time 0 (Pre-dose) up to 6 Hours Post-dose (AUC0-6) for Albuterol on Days 1 and 8
Ramy czasowe: Days 1 and 8

Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).

AUC0-6 on Day 8 is not from pre-dose but at steady state.
Days 1 and 8
Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t) for Albuterol on Days 1 and 8
Ramy czasowe: Days 1 and 8

Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).

AUC0-t on Day 8 is not from pre-dose but at steady state.
Days 1 and 8
Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Infinity Post-dose(AUC0-inf) for Albuterol on Day 1
Ramy czasowe: Day 1
Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).
Day 1
Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose(AUC0-24) for Albuterol on Day 8
Ramy czasowe: Day 8
Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).
Day 8
Terminal Plasma Half-life (t1/2) for Albuterol on Days 1 and 8
Ramy czasowe: Days 1 and 8
Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).
Days 1 and 8

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

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

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 grudnia 2012

Zakończenie podstawowe (Rzeczywisty)

1 października 2013

Ukończenie studiów (Rzeczywisty)

1 listopada 2013

Daty rejestracji na studia

Pierwszy przesłany

7 grudnia 2012

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 grudnia 2012

Pierwszy wysłany (Oszacować)

11 grudnia 2012

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

26 czerwca 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

28 maja 2015

Ostatnia weryfikacja

1 maja 2015

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ABS-AS-304

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