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Trial registered on ANZCTR


Registration number
ACTRN12605000611628
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
6/10/2005
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Date results information initially provided
20/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
DOES USE OF INHALED FLUTICASONE PRIOR TO AN ADENOSINE 5'MONOPHOSPHATE (AMP) BRONCHIAL PROVOCATION TEST AFFECT THE PERCEPTION OF DYSPNOEA?
Scientific title
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?
Secondary ID [1] 190 0
Woolcock Institute of Medical Research
Universal Trial Number (UTN)
Trial acronym
PD-NS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 742 0
Allergic Rhinitis 743 0
Condition category
Condition code
Respiratory 818 818 0 0
Asthma
Inflammatory and Immune System 819 819 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fluticasone 250mcg inhaled 2 or 14 hours before Adenosine 5' Monophostate Bronchial provocation. Perception of Dyspnoea and Nasal symptoms developed are recorded.
Intervention code [1] 632 0
None
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1051 0
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.
Timepoint [1] 1051 0
Secondary outcome [1] 1954 0
Effect of acutely inhaled FP on FEV1, EF25-75%, IC and FVC.
Timepoint [1] 1954 0
All secondary outcomes are measured during and immediatly after the challenge.
Secondary outcome [2] 1955 0
Effect of AMP Bronchial Provocative test in development of nasal symptoms.
Timepoint [2] 1955 0
All secondary outcomes are measured during and immediatly after the challenge.
Secondary outcome [3] 1956 0
Effect of acutely inhaled FP on the nasal symptoms.
Timepoint [3] 1956 0
All secondary outcomes are measured during and immediatly after the challenge.

Eligibility
Key inclusion criteria
Allergy to inhaled allergens. Mild asthma and rhinitis.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will attend the unit to receive the medication, they will be allocated to a treatment sequence which is described in the protocol. The sequence is concealed by allocating a number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Different combinations of FP2h, FP14 and Placebo 2 and 14 were organized. Subjects will receive an envelope that has a letter that identifies the sequence in which the medication will be given. The objective is to avoid the researcher is involved in the sequence selection and the patients are blinded to the order in which they will receive the medication.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 907 0
Other
Name [1] 907 0
Woolcock Institute of Medical Research
Address [1] 907 0
Country [1] 907 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 766 0
None
Name [1] 766 0
Nil
Address [1] 766 0
Country [1] 766 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302241 0
Estimate - details not known
Ethics committee address [1] 302241 0
Estimate - details not known
Ethics committee country [1] 302241 0
Date submitted for ethics approval [1] 302241 0
01/09/2005
Approval date [1] 302241 0
01/09/2005
Ethics approval number [1] 302241 0
Unknown

Summary
Brief summary
Trial website
Trial related presentations / publications
Estimate - details not known
Public notes

Contacts
Principal investigator
Name 36292 0
Address 36292 0
Country 36292 0
Phone 36292 0
Fax 36292 0
Email 36292 0
Contact person for public queries
Name 9821 0
Ms Wendy Taylor
Address 9821 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9821 0
Australia
Phone 9821 0
+61 2 95156578
Fax 9821 0
+61 2 95505865
Email 9821 0
volunteers@woolcock.org.au
Contact person for scientific queries
Name 749 0
Dr Cica Santos
Address 749 0
Woolcock Institute of Medical Research
Royal Prince Alfred Hospital
Building 92 Level 3
Camperdown NSW 2050
Country 749 0
Australia
Phone 749 0
+61 2 95158632
Fax 749 0
+61 2 95505865
Email 749 0
cica@woolcock.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary