Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics
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
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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California
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Costa Mesa, California, Yhdysvallat
- Teva Investigational Site 10225
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Encinitas, California, Yhdysvallat
- Teva Investigational Site 10250
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Huntington Beach, California, Yhdysvallat
- Teva Investigational Site 10230
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Palmdale, California, Yhdysvallat
- Teva Investigational Site 10255
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Rancho Mirage, California, Yhdysvallat
- Teva Investigational Site 10231
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Riverside, California, Yhdysvallat
- Teva Investigational Site 10252
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Rolling Hills Estates, California, Yhdysvallat
- Teva Investigational Site 10242
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San Diego, California, Yhdysvallat
- Teva Investigational Site 10238
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San Jose, California, Yhdysvallat
- Teva Investigational Site 10243
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Florida
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Miami Lakes, Florida, Yhdysvallat
- Teva Investigational Site 10247
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Tallahassee, Florida, Yhdysvallat
- Teva Investigational Site 10239
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Tampa, Florida, Yhdysvallat
- Teva Investigational Site 10234
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Maine
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Bangor, Maine, Yhdysvallat
- Teva Investigational Site 10253
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Maryland
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Baltimore, Maryland, Yhdysvallat
- Teva Investigational Site 10257
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White Marsh, Maryland, Yhdysvallat
- Teva Investigational Site 10254
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Massachusetts
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Fall River, Massachusetts, Yhdysvallat
- Teva Investigational Site 10235
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North Dartmouth, Massachusetts, Yhdysvallat
- Teva Investigational Site 10236
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Minnesota
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Minneapolis, Minnesota, Yhdysvallat
- Teva Investigational Site 10226
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Minneapolis, Minnesota, Yhdysvallat
- Teva Investigational Site 10233
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Missouri
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St. Louis, Missouri, Yhdysvallat
- Teva Investigational Site 10241
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Nebraska
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Bellevue, Nebraska, Yhdysvallat
- Teva Investigational Site 10229
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New York
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Rochester, New York, Yhdysvallat
- Teva Investigational Site 10227
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North Carolina
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Charlotte, North Carolina, Yhdysvallat
- Teva Investigational Site 10244
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Ohio
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Cincinnati, Ohio, Yhdysvallat
- Teva Investigational Site 10248
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Oklahoma
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Oklahoma City, Oklahoma, Yhdysvallat
- Teva Investigational Site 10249
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Oregon
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Eugene, Oregon, Yhdysvallat
- Teva Investigational Site 10232
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Medford, Oregon, Yhdysvallat
- Teva Investigational Site 10259
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Portland, Oregon, Yhdysvallat
- Teva Investigational Site 10237
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Pennsylvania
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Bethlehem, Pennsylvania, Yhdysvallat
- Teva Investigational Site 10240
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Pittsburgh, Pennsylvania, Yhdysvallat
- Teva Investigational Site 10246
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Pittsburgh, Pennsylvania, Yhdysvallat
- Teva Investigational Site 10256
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South Carolina
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Rock Hill, South Carolina, Yhdysvallat
- Teva Investigational Site 10251
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Spartanburg, South Carolina, Yhdysvallat
- Teva Investigational Site 10228
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Texas
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San Antonio, Texas, Yhdysvallat
- Teva Investigational Site 10258
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Washington
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Seattle, Washington, Yhdysvallat
- Teva Investigational Site 10245
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Placebo Comparator: Placebo MDPI
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
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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.
Muut nimet:
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Kokeellinen: 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.
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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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
Aikaikkuna: Day 1, Day 8 and Day 85
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
Aikaikkuna: Day 1
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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
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8
Aikaikkuna: Day 8
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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
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85
Aikaikkuna: Day 85
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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
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Participants With Adverse Events
Aikaikkuna: Day 1 to Day 93
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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.
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Day 1 to Day 93
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Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group
Aikaikkuna: Day 1 (Baseline), Day 85
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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.
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Day 1 (Baseline), Day 85
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Participants With Clinically Significant Vital Sign Assessments
Aikaikkuna: Days 8 and 85
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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
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Maximum Observed Plasma Drug Concentration (Cmax) for Albuterol on Days 1 and 8
Aikaikkuna: Days 1 and 8
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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).
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Days 1 and 8
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Time to Observed Peak Plasma Concentration (Tmax) for Albuterol on Days 1 and 8
Aikaikkuna: Days 1 and 8
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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).
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Days 1 and 8
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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
Aikaikkuna: Days 1 and 8
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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
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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
Aikaikkuna: Days 1 and 8
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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
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Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Infinity Post-dose(AUC0-inf) for Albuterol on Day 1
Aikaikkuna: Day 1
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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).
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Day 1
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Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose(AUC0-24) for Albuterol on Day 8
Aikaikkuna: Day 8
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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).
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Day 8
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Terminal Plasma Half-life (t1/2) for Albuterol on Days 1 and 8
Aikaikkuna: Days 1 and 8
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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).
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Days 1 and 8
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Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Hengityselinten sairaudet
- Immuunijärjestelmän sairaudet
- Keuhkosairaudet
- Yliherkkyys, välitön
- Keuhkoputken sairaudet
- Keuhkosairaudet, obstruktiiviset
- Hengitysteiden yliherkkyys
- Yliherkkyys
- Astma
- Huumeiden fysiologiset vaikutukset
- Adrenergiset aineet
- Neurotransmitterit
- Farmakologisen vaikutuksen molekyylimekanismit
- Autonomiset agentit
- Ääreishermoston aineet
- Adrenergiset agonistit
- Keuhkoputkia laajentavat aineet
- Astmaattiset aineet
- Hengityselinten aineet
- Lisääntymistä säätelevät aineet
- Adrenergiset beeta-2-reseptoriagonistit
- Adrenergiset beeta-agonistit
- Tokolyyttiset aineet
- Albuteroli
Muut tutkimustunnusnumerot
- ABS-AS-304
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