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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12605000611628 |
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Date of registration:
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06/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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DOES USE OF INHALED FLUTICASONE PRIOR TO AN ADENOSINE 5'MONOPHOSPHATE (AMP) BRONCHIAL PROVOCATION TEST AFFECT THE PERCEPTION OF DYSPNOEA?
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Scientific title:
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DOES USE OF INHALED FLUTICASONE PRIOR TO AN ADENOSINE 5'MONOPHOSPHATE (AMP) BRONCHIAL PROVOCATION TEST AFFECT THE PERCEPTION OF DYSPNOEA in asthmatic patients and the development of nasal symptoms? |
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Date of first enrolment:
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01/10/2005 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12605000611628.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
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Phase:
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Phase 3 / Phase 4
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Cica Santos
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Address:
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Woolcock Institute of Medical Research
Royal Prince Alfred Hospital
Building 92 Level 3
Camperdown NSW 2050
Australia |
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Telephone:
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+61 2 95158632 |
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Email:
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cica@woolcock.org.au |
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Affiliation:
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Name:
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Ms Wendy Taylor
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Address:
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Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Australia |
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Telephone:
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+61 2 95156578 |
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Email:
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volunteers@woolcock.org.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Allergy to inhaled allergens. Mild asthma and rhinitis.
Exclusion criteria: No exclusion criteria
Age minimum:
Not stated
Age maximum:
Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Respiratory - Asthma
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Inflammatory and Immune System - Allergies
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Asthma;Allergic Rhinitis;
Asthma
Allergic Rhinitis
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Intervention(s)
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Fluticasone 250mcg inhaled 2 or 14 hours before Adenosine 5' Monophostate Bronchial provocation. Perception of Dyspnoea and Nasal symptoms developed are recorded.
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Primary Outcome(s)
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To investigate the acute effect of single dose of 250µg fluticasone propionate (FP) on perception of dyspnoea during AMP Bronchial provocative test, given 2 or 14hours pre test.[]
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Secondary Outcome(s)
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Effect of AMP Bronchial Provocative test in development of nasal symptoms.[All secondary outcomes are measured during and immediatly after the challenge.]
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Effect of acutely inhaled FP on the nasal symptoms.[All secondary outcomes are measured during and immediatly after the challenge.]
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Effect of acutely inhaled FP on FEV1, EF25-75%, IC and FVC.[All secondary outcomes are measured during and immediatly after the challenge.]
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Secondary ID(s)
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Woolcock Institute of Medical Research
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Source(s) of Monetary Support
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Woolcock Institute of Medical Research
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Ethics review
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Status: Approved
Approval date:
Contact:
Estimate - details not known
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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