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- Sperimentazione clinica NCT03562923
A Study to Compare Fluticasone Propionate 100mcg/Salmeterol 50 mcg Inhalation Powder to Advair Discus 100/50
A Randomized Single Blind Placebo-Controlled Multi-Center Study Comparing Combination Therapy With Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder to Combination Therapy With ADVAIR DISKUS® 100/50 (Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder) in Treatment of Subjects With Asthma
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: Irshad Haque
- Numero di telefono: 631-952-0214
- Email: ihaque@amneal.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Male or female subjects (≥ 12 years of age) of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control.
- Diagnosed with asthma as defined by the National Asthma Education and Prevention Program (NAEPP) at least 12 weeks prior to screening.
- Pre-bronchodilator FEV1 of ≥40% and ≤85% of the predicted value during the screening visit and on the first day of treatment.
- Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had ≤ 10 pack-years of historical use.
- ≥15% reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI).
- Able to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for remainder of the study.
- Able to replace current short-acting β agonists (SABAs) with salbutamol/albuterol inhaler for use as needed for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits).
Able to continue the following medications without a significant adjustment of dosage, formulation, dosing interval for the duration of the study, and judged able by the investigator to withhold them for the specified minimum time intervals prior to each clinic visit:
- short-acting forms of theophylline 12 hours
- twice-a-day controlled-release forms of theophylline 24 hours
- once-a-day controlled-release forms of theophylline 36 hours
- Able to discontinue the following medications for the specified minimum time intervals prior to the run-in period and for the remainder of the study:
- oral corticosteroids 1 month
- parenteral corticosteroids 1 month
- oral short-acting β-agonists 12 hours
- Willingness to give their (and in the case of a minor their parent/guardian was able to give) written informed consent to participate in the study.
Exclusion Criteria:
- Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year or during the run-in period.
- Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
- Hypersensitivity to any sympathomimetic drug (e.g., salmeterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy.
Medication(s) with the potential to affect the course of asthma or to interact with sympathomimetic amines, e.g.:
- β-blockers
- oral decongestants
- benzodiazepines
- digitalis
- phenothiazines
- polycyclic antidepressants
- Monoamine oxidase inhibitors
- Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit or during the run-in period.
- Factors (e.g., infirmity, disability or geographic location) that the investigator felt would likely limit the patient's compliance with the study protocol or scheduled clinic visits.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: Placebo
Prodotto placebo 2 volte al giorno
|
Prodotto placebo
|
Sperimentale: Test Product
Test Product, 100/50 mcg, 2 x daily
|
Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder
|
Comparatore attivo: Reference Product
Reference Product, 100/50 mcg, 2 x daily
|
ADVAIR DISKUS® 100/50 (Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder)
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Baseline-adjusted area under the serial FEV1-time curve
Lasso di tempo: 0-12 hours after dosing on day 1
|
Baseline-adjusted area under the serial FEV1-time curve calculated from time zero to 12 hours (AUC0-12h) on the first day of treatment.
|
0-12 hours after dosing on day 1
|
Baseline-adjusted, pre-dose FEV1
Lasso di tempo: 4-weeks
|
Baseline-adjusted, pre-dose FEV1 on the last day of a 4-week treatment
|
4-weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Irshad Haque, Amneal Pharmaceuticals, LLC
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Malattie del sistema immunitario
- Malattie polmonari
- Ipersensibilità, immediata
- Malattie bronchiali
- Malattie polmonari, ostruttive
- Ipersensibilità respiratoria
- Ipersensibilità
- Asma
- Effetti fisiologici delle droghe
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti broncodilatatori
- Agenti antiasmatici
- Agenti del sistema respiratorio
- Simpaticomimetici
- Combinazione di farmaci fluticasone-salmeterolo
Altri numeri di identificazione dello studio
- AI-FSX-001
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .