- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01424813
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
A 12-week Comparison of the Efficacy and Safety of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis
- Teva Investigational Site 10077
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Arizona
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Phoenix, Arizona, États-Unis
- Teva Investigational Site 10079
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California
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Costa Mesa, California, États-Unis
- Teva Investigational Site 10569
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Fountain Valley, California, États-Unis
- Teva Investigational Site 10053
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Huntington Beach, California, États-Unis
- Teva Investigational Site 10065
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Huntington Beach, California, États-Unis
- Teva Investigational Site 10572
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Los Angeles, California, États-Unis
- Teva Investigational Site 10075
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Roseville, California, États-Unis
- Teva Investigational Site 10061
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San Diego, California, États-Unis
- Teva Investigational Site 10066
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Colorado
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Denver, Colorado, États-Unis
- Teva Investigational Site 10068
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Denver, Colorado, États-Unis
- Teva Investigational Site 10069
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Florida
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Miami, Florida, États-Unis
- Teva Investigational Site 10058
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Miami, Florida, États-Unis
- Teva Investigational Site 10060
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Ormond Beach, Florida, États-Unis
- Teva Investigational Site 10064
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Georgia
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Savannah, Georgia, États-Unis
- Teva Investigational Site 10071
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Kansas
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Wichita, Kansas, États-Unis
- Teva Investigational Site 10073
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Kentucky
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Owensboro, Kentucky, États-Unis
- Teva Investigational Site 10070
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Maryland
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Bethesda, Maryland, États-Unis
- Teva Investigational Site 10063
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Gaithersburg, Maryland, États-Unis
- Teva Investigational Site 10571
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Wheaton, Maryland, États-Unis
- Teva Investigational Site 10067
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Missouri
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St. Louis, Missouri, États-Unis
- Teva Investigational Site 10072
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Montana
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Missoula, Montana, États-Unis
- Teva Investigational Site 10050
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North Carolina
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Raleigh, North Carolina, États-Unis
- Teva Investigational Site 10057
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Ohio
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Cincinnati, Ohio, États-Unis
- Teva Investigational Site 10051
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Sylvania, Ohio, États-Unis
- Teva Investigational Site 10078
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis
- Teva Investigational Site 10054
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Oklahoma City, Oklahoma, États-Unis
- Teva Investigational Site 10568
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Tulsa, Oklahoma, États-Unis
- Teva Investigational Site 10055
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Oregon
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Medford, Oregon, États-Unis
- Teva Investigational Site 10056
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Medford, Oregon, États-Unis
- Teva Investigational Site 10076
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South Carolina
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Charleston, South Carolina, États-Unis
- Teva Investigational Site 10684
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Spartanburg, South Carolina, États-Unis
- Teva Investigational Site 10570
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Texas
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Live Oak, Texas, États-Unis
- Teva Investigational Site 10049
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San Antonio, Texas, États-Unis
- Teva Investigational Site 10052
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Waco, Texas, États-Unis
- Teva Investigational Site 10685
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Virginia
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Fairfax, Virginia, États-Unis
- Teva Investigational Site 10059
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Washington
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Puyallup, Washington, États-Unis
- Teva Investigational Site 10074
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Tacoma, Washington, États-Unis
- Teva Investigational Site 10062
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: 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.
Autres noms:
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Expérimental: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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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
Délai: 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) 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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
Délai: 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. 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
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8
Délai: 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. 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
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Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85
Délai: 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. 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
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Participants With Adverse Events
Délai: Day 1 to Day 92
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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 92
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Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group
Délai: 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
Délai: Day 8, Day 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 |
Day 8, Day 85
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period
Délai: Day 1, Day 8, Day 85
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Day 1, Day 8, Day 85
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Percent Change From Baseline in FEV1 AUC 0-6
Délai: Day 1
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Day 1
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Percent Change From Baseline in FEV1 AUC
Délai: Day 8
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Day 8
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Percent Change From Baseline in FEV1 AUC
Délai: Day 85
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Day 85
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Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period
Délai: Day 1, Day 8, Day 85
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Day 1, Day 8, Day 85
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Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 1
Délai: Day 1
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Day 1
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Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8
Délai: Day 8
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Day 8
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Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85
Délai: Day 85
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Day 85
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Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)
Délai: Day 1, Day 8, Day 85
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Day 1, Day 8, Day 85
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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
Délai: Day 1, Day 8, Day 85
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Day 1, Day 8, Day 85
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Time to Onset of Effect (Change in FEV1 of 15% From Baseline Within 30 Minutes Postdose)for Those Who Responded in 30 Minutes
Délai: Day 1, Day 8, Day 85
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Day 1, Day 8, Day 85
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Duration of Response on Days 1, 8 and 85
Délai: Day 1, Day 8, Day 85
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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
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Day 1, Day 8, Day 85
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Percent of Symptom Free Days on the Patient Diary
Délai: Treatment days 1 through 85
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Treatment days 1 through 85
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Percent of Rescue Medication Free Days in the Patient Diary
Délai: Treatment days 1 through 85
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Treatment days 1 through 85
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Morning Peak Expiratory Flow Reading Reported on Patient Diary
Délai: Treatment days 1 through 85
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Treatment days 1 through 85
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Collaborateurs et enquêteurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Maladies du système immunitaire
- Maladies pulmonaires
- Hypersensibilité immédiate
- Maladies bronchiques
- Maladies pulmonaires obstructives
- Hypersensibilité respiratoire
- Hypersensibilité
- Asthme
- Effets physiologiques des médicaments
- Agents adrénergiques
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents autonomes
- Agents du système nerveux périphérique
- Agonistes adrénergiques
- Agents bronchodilatateurs
- Agents anti-asthmatiques
- Agents du système respiratoire
- Agents de contrôle de la reproduction
- Agonistes des récepteurs bêta-2 adrénergiques
- Bêta-agonistes adrénergiques
- Agents tocolytiques
- Albutérol
Autres numéros d'identification d'étude
- ABS-AS-301
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Essais cliniques sur Placebo MDPI
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Teva Branded Pharmaceutical Products R&D, Inc.Complété
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