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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 mei 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

158

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo MDPI
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Geneesmiddel: 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®
Experimenteel: 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.
Geneesmiddel: 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®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period
Tijdsspanne: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Percent Change From Baseline in FEV1 AUC 0-6
Tijdsspanne: Day 1
Day 1
Percent Change From Baseline in FEV1 AUC
Tijdsspanne: Day 8
Day 8
Percent Change From Baseline in FEV1 AUC
Tijdsspanne: Day 85
Day 85
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period
Tijdsspanne: 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
Tijdsspanne: Day 1
Day 1
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8
Tijdsspanne: Day 8
Day 8
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85
Tijdsspanne: Day 85
Day 85
Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Duration of Response on Days 1, 8 and 85
Tijdsspanne: 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
Tijdsspanne: Treatment days 1 through 85
Treatment days 1 through 85
Percent of Rescue Medication Free Days in the Patient Diary
Tijdsspanne: Treatment days 1 through 85
Treatment days 1 through 85
Morning Peak Expiratory Flow Reading Reported on Patient Diary
Tijdsspanne: Treatment days 1 through 85
Treatment days 1 through 85

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2012

Primaire voltooiing (Werkelijk)

1 oktober 2013

Studie voltooiing (Werkelijk)

1 november 2013

Studieregistratiedata

Eerst ingediend

25 augustus 2011

Eerst ingediend dat voldeed aan de QC-criteria

25 augustus 2011

Eerst geplaatst (Schatting)

29 augustus 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

26 juni 2015

Laatste update ingediend die voldeed aan QC-criteria

28 mei 2015

Laatst geverifieerd

1 mei 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ABS-AS-301

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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