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Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)

31. januar 2022 opdateret af: Organon and Co

A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast on Exercise-Induced Bronchospasm

The purpose of this study is to determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercise.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

62

Fase

  • Fase 3

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

15 år til 45 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with mild-to-moderate asthma

Exclusion Criteria:

  • Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
  • Patient is, other than asthma, not in good, stable health
  • The Primary Investigator will evaluate whether there are other reasons why

the patient may not participate

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Montelukast - Placebo
Medicin: Komparator: Montelukast
Montelukast 10 mg tablet indgivet oralt som en enkelt observeret dosis før træningsudfordring
Medicin: Komparator: Placebo
Placebotablet administreret oralt som en enkelt observeret dosis før træningsudfordring
Eksperimentel: 2
Placebo - Montelukast
Medicin: Komparator: Montelukast
Montelukast 10 mg tablet indgivet oralt som en enkelt observeret dosis før træningsudfordring
Medicin: Komparator: Placebo
Placebotablet administreret oralt som en enkelt observeret dosis før træningsudfordring

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
Tidsramme: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Område under kurven for FEV1 procentvis ændring fra før træningsbaseline i løbet af de 60 minutter efter træningsudfordring (AUC 0-60 min) 24 timer efter dosis
Tidsramme: Grundlinjemåling før træning og 0-60 minutter efter træningsudfordringen udført 24 timer efter dosis
Foranstaltningen omfattede kun området under baseline før træning.
Grundlinjemåling før træning og 0-60 minutter efter træningsudfordringen udført 24 timer efter dosis
Tid til restitution fra maksimal procentvis fald i FEV1 efter træningsudfordring 2 timer efter dosis
Tidsramme: Træningsudfordring 2 timer efter dosis
Tiden til restitution fra det maksimale procentvise fald er varigheden mellem det tidspunkt, hvor det maksimale procentvise fald i FEV1 efter træningsudfordring indtræffer, og det tidspunkt, hvor FEV1 vender tilbage til inden for 5 % af baseline før træning for første gang.
Træningsudfordring 2 timer efter dosis
Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
Tidsramme: 0-90 minutes after the exercise challenge performed at 2 hours postdose
0-90 minutes after the exercise challenge performed at 2 hours postdose
Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose
Tidsramme: 0-90 minutes after the exercise challenge performed at 12 hours postdose
0-90 minutes after the exercise challenge performed at 12 hours postdose
Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose
Tidsramme: 0-90 minutes after the exercise challenge performed at 24 hours postdose
0-90 minutes after the exercise challenge performed at 24 hours postdose
Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB
Tidsramme: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose
In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB
Tidsramme: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose
In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose
Tidsramme: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose
The measure included only the area below the pre-exercise baseline.
Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose
Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 12 Hours Postdose
Tidsramme: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose
The measure included only the area below the pre-exercise baseline.
Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose
Tidsramme: Exercise challenge at 12 hours postdose
The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Exercise challenge at 12 hours postdose
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose
Tidsramme: Exercise challenge at 24 hours postdose
The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Exercise challenge at 24 hours postdose

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Organon and Co

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.

Generelle publikationer

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. maj 2004

Primær færdiggørelse (Faktiske)

1. oktober 2004

Studieafslutning (Faktiske)

1. oktober 2004

Datoer for studieregistrering

Først indsendt

24. august 2004

Først indsendt, der opfyldte QC-kriterier

25. august 2004

Først opslået (Skøn)

26. august 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0476-275
  • 2004_009

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