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A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma

28. Mai 2015 aktualisiert von: Teva Branded Pharmaceutical Products R&D, Inc.

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

The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

158

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten
        • Teva Investigational Site 10077
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten
        • Teva Investigational Site 10079
    • California
      • Costa Mesa, California, Vereinigte Staaten
        • Teva Investigational Site 10569
      • Fountain Valley, California, Vereinigte Staaten
        • Teva Investigational Site 10053
      • Huntington Beach, California, Vereinigte Staaten
        • Teva Investigational Site 10065
      • Huntington Beach, California, Vereinigte Staaten
        • Teva Investigational Site 10572
      • Los Angeles, California, Vereinigte Staaten
        • Teva Investigational Site 10075
      • Roseville, California, Vereinigte Staaten
        • Teva Investigational Site 10061
      • San Diego, California, Vereinigte Staaten
        • Teva Investigational Site 10066
    • Colorado
      • Denver, Colorado, Vereinigte Staaten
        • Teva Investigational Site 10068
      • Denver, Colorado, Vereinigte Staaten
        • Teva Investigational Site 10069
    • Florida
      • Miami, Florida, Vereinigte Staaten
        • Teva Investigational Site 10058
      • Miami, Florida, Vereinigte Staaten
        • Teva Investigational Site 10060
      • Ormond Beach, Florida, Vereinigte Staaten
        • Teva Investigational Site 10064
    • Georgia
      • Savannah, Georgia, Vereinigte Staaten
        • Teva Investigational Site 10071
    • Kansas
      • Wichita, Kansas, Vereinigte Staaten
        • Teva Investigational Site 10073
    • Kentucky
      • Owensboro, Kentucky, Vereinigte Staaten
        • Teva Investigational Site 10070
    • Maryland
      • Bethesda, Maryland, Vereinigte Staaten
        • Teva Investigational Site 10063
      • Gaithersburg, Maryland, Vereinigte Staaten
        • Teva Investigational Site 10571
      • Wheaton, Maryland, Vereinigte Staaten
        • Teva Investigational Site 10067
    • Missouri
      • St. Louis, Missouri, Vereinigte Staaten
        • Teva Investigational Site 10072
    • Montana
      • Missoula, Montana, Vereinigte Staaten
        • Teva Investigational Site 10050
    • North Carolina
      • Raleigh, North Carolina, Vereinigte Staaten
        • Teva Investigational Site 10057
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten
        • Teva Investigational Site 10051
      • Sylvania, Ohio, Vereinigte Staaten
        • Teva Investigational Site 10078
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten
        • Teva Investigational Site 10054
      • Oklahoma City, Oklahoma, Vereinigte Staaten
        • Teva Investigational Site 10568
      • Tulsa, Oklahoma, Vereinigte Staaten
        • Teva Investigational Site 10055
    • Oregon
      • Medford, Oregon, Vereinigte Staaten
        • Teva Investigational Site 10056
      • Medford, Oregon, Vereinigte Staaten
        • Teva Investigational Site 10076
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten
        • Teva Investigational Site 10684
      • Spartanburg, South Carolina, Vereinigte Staaten
        • Teva Investigational Site 10570
    • Texas
      • Live Oak, Texas, Vereinigte Staaten
        • Teva Investigational Site 10049
      • San Antonio, Texas, Vereinigte Staaten
        • Teva Investigational Site 10052
      • Waco, Texas, Vereinigte Staaten
        • Teva Investigational Site 10685
    • Virginia
      • Fairfax, Virginia, Vereinigte Staaten
        • Teva Investigational Site 10059
    • Washington
      • Puyallup, Washington, Vereinigte Staaten
        • Teva Investigational Site 10074
      • Tacoma, Washington, Vereinigte Staaten
        • Teva Investigational Site 10062

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Written informed consent/assent
  • General good health
  • Persistent asthma, with an FEV1 50-80% predicted.
  • Ability to perform spirometry in an acceptable manner as per protocol guidelines.
  • Ability to perform PEFR with a handheld peak flow meter.
  • Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.
  • Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.
  • Non-smokers.
  • Capable of understanding the requirements, risks, and benefits of study participation.
  • Other inclusion criteria apply.

Exclusion Criteria:

  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV).
  • A known hypersensitivity to albuterol or any of the excipients in the formulations.
  • History of severe milk protein allergy.
  • History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV).
  • Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.
  • 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 Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).
  • Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.
  • Other exclusion criteria apply.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo MDPI
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Arzneimittel: 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.
Andere Namen:
  • Placebo Spiromax®
Experimental: 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.
Arzneimittel: 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.
Andere Namen:
  • ProAir® RespiClick, Albuterol Spiromax®

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
Zeitfenster: 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) of 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
Zeitfenster: 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. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 1.

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
Zeitfenster: 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. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 8.

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
Zeitfenster: 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. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 85.

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
Zeitfenster: Day 1 to Day 92
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 92
Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group
Zeitfenster: 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
Zeitfenster: Day 8, Day 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
Day 8, Day 85

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period
Zeitfenster: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Percent Change From Baseline in FEV1 AUC 0-6
Zeitfenster: Day 1
Day 1
Percent Change From Baseline in FEV1 AUC
Zeitfenster: Day 8
Day 8
Percent Change From Baseline in FEV1 AUC
Zeitfenster: Day 85
Day 85
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period
Zeitfenster: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 1
Zeitfenster: Day 1
Day 1
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8
Zeitfenster: Day 8
Day 8
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85
Zeitfenster: Day 85
Day 85
Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)
Zeitfenster: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Duration of Response Measured From the Time Post-dosing to the First Time After the Response Onset (Increase ≥12% Above Baseline) When the FEV1 Decreases to Less Than 12% Above Baseline (Within 6 Hours After Dosing) for Those Who Responded in 30 Minutes
Zeitfenster: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Time to Onset of Effect (Change in FEV1 of 15% From Baseline Within 30 Minutes Postdose)for Those Who Responded in 30 Minutes
Zeitfenster: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Duration of Response on Days 1, 8 and 85
Zeitfenster: Day 1, Day 8, Day 85
Duration of response measured from the time post-dosing to the first time after the response onset (increase ≥15% above baseline) when the FEV1 decreases to less than 15% above baseline (within 6 hours after dosing) for those who responded within 30 minutes
Day 1, Day 8, Day 85
Percent of Symptom Free Days on the Patient Diary
Zeitfenster: Treatment days 1 through 85
Treatment days 1 through 85
Percent of Rescue Medication Free Days in the Patient Diary
Zeitfenster: Treatment days 1 through 85
Treatment days 1 through 85
Morning Peak Expiratory Flow Reading Reported on Patient Diary
Zeitfenster: Treatment days 1 through 85
Treatment days 1 through 85

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2012

Primärer Abschluss (Tatsächlich)

1. Oktober 2013

Studienabschluss (Tatsächlich)

1. November 2013

Studienanmeldedaten

Zuerst eingereicht

25. August 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. August 2011

Zuerst gepostet (Schätzen)

29. August 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

26. Juni 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Mai 2015

Zuletzt verifiziert

1. Mai 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ABS-AS-301

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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