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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 maj 2015 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

158

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo MDPI
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Läkemedel: 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.
Andra namn:
  • Placebo Spiromax®
Experimentell: 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.
Läkemedel: 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.
Andra namn:
  • ProAir® RespiClick, Albuterol Spiromax®

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2012

Primärt slutförande (Faktisk)

1 oktober 2013

Avslutad studie (Faktisk)

1 november 2013

Studieregistreringsdatum

Först inskickad

25 augusti 2011

Först inskickad som uppfyllde QC-kriterierna

25 augusti 2011

Första postat (Uppskatta)

29 augusti 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

26 juni 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 maj 2015

Senast verifierad

1 maj 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ABS-AS-301

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