- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00385359
A Pilot Efficacy Study of Inhaled Albuterol Delivered With Akita Breath Control
A Pilot Efficacy Study of Inhaled Albuterol Delivered With Akita Breath Control and Pari Nebulization for the Treatment of Adults With Moderate Asthma
Albuterol (salbutamol) is a widely used asthma medication but is associated with undesirable side effects such as shakiness and increased heart rate. Targeted delivery of albuterol to area of lungs where it has most effect would require a lower total dose to produce the same beneficial effects while reducing the side effects.
It is anticipated that only 1/13th to 1/25th of the standard nebulized dose of albuterol will be required to attain same bronchodilator response as a standard nebulizer treatment as determined by lung function measurement and that the reduced dose will significantly reduce side effects as determined by hand tremor and heart rate.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Side effects of albuterol (salbutamol)are directly related to the dose delivered and absorbed into blood stream. By controlling aerosol delivery, dose delivered, site of deposition, amount of drug absorption can be determined and thus the magnitude of the side effects. Delivery and deposition of aerosols are determined by both aerosol characteristics (size and timing of delivery) and breathing characteristics (breath size, flow rate and breathholding). Data supports the theory that if a high dose of albuterol can be deposited in the larger airway generations and prevented from entering the pulmonary circulation from the lung periphery, that this will result in the largest magnitude of bronchodilator response with the lowest circulatory absorbance.
This is a pilot study in 10 adults with moderate asthma. there are no investigational drugs or devices. It is an investigation of a strategy to maximize response to an approved drug while minimizing side effects. The investigational strategies will deposit less than 25% of the standard nebulized dose in the airways. This will be accomplished by pairing a Pari eFlow nebulizer configured to deliver particle sizes of 3.5 to 6 microns, with an Akita delivery system programmed to deliver the drug as either a late or early bolus during inspiration. The Akita is programmed with a specific breathing pattern based on participant's lung function tests at screening.
Moderate asthmatics with bronchodilator response >20% improvement in FEV1 will be selected. Treatments will be administered on separate days 1-7 days apart. Following baseline measurements 1 of 5 randomized aerosol treatments will be administered. Efficacy (FEV1) and side effects (tremor and heart rate)will be monitored for 6 hours following drug administration.
Tipo di studio
Iscrizione
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Reclutamento
- Toronto Western Hospital - Respiratory Research Lab
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Male or female aged 18-60 years
- Moderate asthma with baseline FEV1 40-75% predicted
- Previous use of albuterol (salbutamol)
- At least 20% improvement in FEV1 following 2.5 mg albuterol (salbutamol) delivered by nebulizer
- O2 saturation > 90%
- Non-smoker for > 6 months
Exclusion Criteria:
- Upper respiratory tract infection or asthma exacerbation within 14 days of screening
- Clinically significant abnormal chest radiograph
- History of cardiovascular disorder including coronary insufficiency, cardiac arrhythmias or hypertension
- Unable to tolerate bronchodilator withdrawal
- Known hypersensitivity to albuterol (salbutamol)
- Change in asthma treatment regimen in past 30 days
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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change in FEV1 expressed as a percent of predicted between baseline and 1 hour post drug administration.
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Misure di risultato secondarie
Misura del risultato |
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duration of effect based on FEV1 at 6 hours post treatment compared to standard treatment
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change in hand tremor compared to standard treatment
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change in heart rate compared to standard treatment
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Victor Hoffstein, MD, University Health Network, Toronto
Studiare le date dei record
Studia le date principali
Inizio studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
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 adrenergici
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agonisti adrenergici
- Agenti broncodilatatori
- Agenti antiasmatici
- Agenti del sistema respiratorio
- Agenti di controllo riproduttivo
- Agonisti del recettore adrenergico beta-2
- Beta-agonisti adrenergici
- Agenti tocolitici
- Albuterolo
Altri numeri di identificazione dello studio
- IA-01
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 .
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