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Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.

7 mei 2018 bijgewerkt door: AstraZeneca

A Phase IIa, Randomised, Single Dose, Double-blind, Double-dummy, 6 Way Complete Cross-over, Placebo Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of 4 Doses of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Persistent Asthma.

The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

62

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Duitsland
      • Berlin, Duitsland, 10117
        • Almirall Investigational Sites#6
      • Berlin, Duitsland, 14050
        • Almirall Investigational Sites#4
      • Berlin, Duitsland, 14057
        • Almirall Investigational Sites#1
      • Frankfurt, Duitsland, 60596
        • Almirall Investigational Sites#3
      • Grosshansdorf, Duitsland, 22927
        • Almirall Investigational Sites#2
      • Hamburg, Duitsland, 20249
        • Almirall Investigational Sites#8
      • Wiesbaden, Duitsland, 65187
        • Almirall Investigational Sites#5
  • Verenigd Koninkrijk
      • London, Verenigd Koninkrijk, W1G 8HT
        • Almirall Investigational Sites#2
      • Manchester, Verenigd Koninkrijk, M3 9QZ
        • Almirall Investigational Sites#1

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Adult male and female patients aged 18-70 years (both included).
  2. Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening.
  3. Screening FEV1 value of 60% < FEV1 ≤ 85% of the predicted normal value.
  4. FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol.
  5. Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation.
  6. Patients on a stable dose and regimen

Exclusion Criteria:

  1. Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
  2. Patients diagnosed with COPD.
  3. Recent Respiratory tract infections within 6 weeks before Screening Visit.
  4. Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit.
  5. Clinically significant respiratory conditions.
  6. Clinically significant cardiovascular conditions.
  7. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
  8. Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
  9. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: LAS100977 0.625 μg
Single-dose LAS100977 0.625 μg, during double-blind treatment period
Geneesmiddel: LAS100977 0.625 μg
Dry powder inhalation, once-daily, single-dose
Geneesmiddel: Salbutamol placebo
Pressurized inhalation, once-daily
Experimenteel: LAS100977 1.25 μg
Single-dose LAS100977 1.25 μg, during double-blind treatment period
Geneesmiddel: Salbutamol placebo
Pressurized inhalation, once-daily
Geneesmiddel: LAS100977 1.25 μg
Dry powder inhalation, once-daily, single-dose
Experimenteel: LAS100977 2.5 μg
Single-dose LAS100977 2.5 μg, during double-blind treatment period
Geneesmiddel: Salbutamol placebo
Pressurized inhalation, once-daily
Geneesmiddel: LAS100977 2.5 μg
Dry powder inhalation, once-daily, single-dose
Actieve vergelijker: Salbutamol
Single-dose salbutamol 400 μg, during double-blind treatment period
Geneesmiddel: Salbutamol 400 μg
Pressurized inhalation suspension, once-daily, single-dose
Geneesmiddel: LAS100977 placebo
Dry powder inhalation, once-daily
Placebo-vergelijker: Placebo
Placebo to LAS100977, and placebo to salbutamol
Geneesmiddel: Salbutamol placebo
Pressurized inhalation, once-daily
Geneesmiddel: LAS100977 placebo
Dry powder inhalation, once-daily
Experimenteel: LAS100977 0.313 μg
Single-dose LAS100977 0.313 μg, during double-blind treatment period
Geneesmiddel: Salbutamol placebo
Pressurized inhalation, once-daily
Geneesmiddel: LAS100977 0.313 μg
Dry powder inhalation, once-daily, single-dose

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Tijdsspanne: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Tijdsspanne: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Peak Forced Expiratory Volume in One Second (FEV1)
Tijdsspanne: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Time to Peak Forced Expiratory Volume in One Second (FEV1)
Tijdsspanne: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)
Tijdsspanne: Baseline and +23 h and +24 h post-dose
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Baseline and +23 h and +24 h post-dose
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1
Tijdsspanne: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
FEV1 was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
Tijdsspanne: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
Tijdsspanne: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
Tijdsspanne: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
Change From Baseline in Peak Forced Vital Capacity (FVC)
Tijdsspanne: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Peak Forced Vital Capacity (FVC)
Tijdsspanne: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h
Time to Peak Forced Vital Capacity (FVC)
Tijdsspanne: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h
Change From Baseline to Trough Forced Vital Capacity (FVC)
Tijdsspanne: Baseline and +23 h +24 h post-dose
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Baseline and +23 h +24 h post-dose
Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC)
Tijdsspanne: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
FVC was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
Tijdsspanne: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
Tijdsspanne: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AstraZeneca

Onderzoekers

  • Studie directeur: Carol Astbury, PhD, AstraZeneca

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2011

Primaire voltooiing (Werkelijk)

1 februari 2012

Studie voltooiing (Werkelijk)

1 februari 2012

Studieregistratiedata

Eerst ingediend

29 augustus 2011

Eerst ingediend dat voldeed aan de QC-criteria

29 augustus 2011

Eerst geplaatst (Schatting)

30 augustus 2011

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 mei 2018

Laatste update ingediend die voldeed aan QC-criteria

7 mei 2018

Laatst geverifieerd

1 april 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • M/100977/202

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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