Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

28. mai 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

160

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo MDPI
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Legemiddel: 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.
Andre navn:
  • Placebo Spiromax®
Eksperimentell: 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.
Legemiddel: 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.
Andre navn:
  • ProAir® RespiClick, Albuterol Spiromax®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2012

Primær fullføring (Faktiske)

1. oktober 2013

Studiet fullført (Faktiske)

1. november 2013

Datoer for studieregistrering

Først innsendt

7. desember 2012

Først innsendt som oppfylte QC-kriteriene

7. desember 2012

Først lagt ut (Anslag)

11. desember 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. juni 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mai 2015

Sist bekreftet

1. mai 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ABS-AS-304

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere