Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma
16. januar 2017 opdateret af: AstraZeneca
Phase II, Randomized, Placebo-controlled, Double-blind, Double-dummy, 5-period Complete Crossover Study of the Bronchodilator Effects of Formoterol Fumarate Inhalation Powder in Patients With Mild to Moderate Asthma.
The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma.
This study will include a screening visit followed by a 4 month treatment period.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
174
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006
- Forest Investigative Site 909
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California
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Encinitas, California, Forenede Stater, 92024
- Forest Investigative Site 2066
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Los Angeles, California, Forenede Stater, 90025
- Forest Investigative Site 1624
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Mission Viejo, California, Forenede Stater, 92691
- Forest Investigative Site 1995
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San Jose, California, Forenede Stater, 95117
- Forest Investigative Site 1347
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Colorado
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Centennial, Colorado, Forenede Stater, 80112
- Forest Investigative Site 1996
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Colorado Springs, Colorado, Forenede Stater, 80907
- Forest Investigative Site 1137
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Denver, Colorado, Forenede Stater, 80230
- Forest Investigative Site 1998
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Florida
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Tampa, Florida, Forenede Stater, 33613
- Forest Investigative Site 2047
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40215
- Forest Investigative Site 1536
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Maryland
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Baltimore, Maryland, Forenede Stater, 21236
- Forest Investigative Site 1333
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Massachusetts
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North Dartmouth, Massachusetts, Forenede Stater, 02747
- Forest Investigative Site 1431
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55402
- Forest Investigative Site 2041
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Missouri
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Saint Louis, Missouri, Forenede Stater, 63141
- Forest Investigative Site 1599
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Nebraska
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Bellevue, Nebraska, Forenede Stater, 68123
- Forest Investigative Site 1609
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New Jersey
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Skillman, New Jersey, Forenede Stater, 08558
- Forest Investigative Site 1999
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North Carolina
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Raleigh, North Carolina, Forenede Stater, 27607
- Forest Investigative Site 1153
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Ohio
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Canton, Ohio, Forenede Stater, 44718
- Forest Investigative Site 1134
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Cincinnati, Ohio, Forenede Stater, 45231
- Forest Investigative Site 1806
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73120
- Forest Investigative Site 1176
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Oregon
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Medford, Oregon, Forenede Stater, 97504
- Forest Investigative Site 2043
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Portland, Oregon, Forenede Stater, 97202
- Forest Investigative Site 1580
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29407
- Forest Investigative Site 2025
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Texas
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Dallas, Texas, Forenede Stater, 75231
- Forest Investigative Site 1155
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El Paso, Texas, Forenede Stater, 79903
- Forest Investigative Site 1332
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New Braunfels, Texas, Forenede Stater, 78130
- Forest Investigative Site 1370
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San Antonio, Texas, Forenede Stater, 78229
- Forest Investigative Site 1699
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Washington
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Seattle, Washington, Forenede Stater, 98115
- Forest Investigative Site 2011
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- Forest Investigative Site 1997
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusions:
- Patients with mild-to-moderate asthma for at least 6 months prior to Visit 1 (as defined in the GINA Guidelines) which is unlikely to exacerbate during the study (e.g., due to seasonal allergen exposure).
- Patients must be on a stable dose of Inhaled Corticosteroids (ICS) for at least 30 days prior to Visit 1. Patients on a combination of ICS/LABA must discontinue the use of LABA and must be on a stable dose of ICS for 30 days prior to Visit 1.
- Qualifying spirometry at Visit 1 demonstrates highest FEV1 is ≤ 85% and ≥ 60% of predicted for age, height, and gender using NHANES III (NHANES 2010) when bronchodilator medications have been withheld the appropriate length of time per the List of Concomitant Medications (Appendix III)
- Patient demonstrates reversibility with an increase in FEV1 of 12% and 200 mL after the administration of 360 µg of albuterol.
- Highest pre-dose FEV1 at Visits 2, 4, 6, 8, and 10 must be within 25% of the qualifying FEV1 at Visit 1
Exclusions:
- Patients with any clinically significant respiratory conditions other than mild to moderate asthma, such as COPD, active tuberculosis, or history of interstitial lung disease
- Patients with a severe asthma exacerbation requiring hospitalization in the previous 12 months
- Patient is not able to withhold use of inhaled short-acting beta-agonist (SABA) for at least 6 hours prior to visit
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Experimental 1
Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose
|
Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days
|
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Eksperimentel: Experimental 2
Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose
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Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days
|
|
Aktiv komparator: Active Comparator 1
Foradil Aerolizer, Low Dose
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Foradil Aerolizer 12 micrograms, twice a day for 14 days
Andre navne:
|
|
Aktiv komparator: Active Comparator 2
Foradil Aerolizer, High Dose
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Foradil Aerolizer 24 micrograms, twice per day for 14 days
Andre navne:
|
|
Placebo komparator: Placebo
Dose matched placebo
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Placebo in the Pressair for 14 days
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)
Tidsramme: Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment
|
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
|
Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)
Tidsramme: Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment
|
AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of Period 1 The time-normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals
|
Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2012
Primær færdiggørelse (Faktiske)
1. februar 2013
Studieafslutning (Faktiske)
1. februar 2013
Datoer for studieregistrering
Først indsendt
12. juli 2012
Først indsendt, der opfyldte QC-kriterier
12. juli 2012
Først opslået (Skøn)
16. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. januar 2017
Sidst verificeret
1. januar 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Sygdomme i immunsystemet
- Lungesygdomme
- Overfølsomhed, Øjeblikkelig
- Bronchiale sygdomme
- Lungesygdomme, obstruktiv
- Respiratorisk overfølsomhed
- Overfølsomhed
- Astma
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Adrenerge agonister
- Bronkodilatatorer
- Anti-astmatiske midler
- Respiratoriske midler
- Adrenerge beta-2-receptoragonister
- Adrenerge beta-agonister
- Formoterolfumarat
Andre undersøgelses-id-numre
- LAC-MD-21
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .