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Trial registered on ANZCTR


Registration number
ACTRN12615000096550
Ethics application status
Approved
Date submitted
9/12/2014
Date registered
4/02/2015
Date last updated
4/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nebulized fluticasone propionate, a viable alternative to systemic route in the management of childhood moderate asthma attack: A double-blind, double-dummy study
Scientific title
Comparison of nebulized fluticasone propionate to systemic steroids in the management of childhood asthma attack
Secondary ID [1] 285807 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma attack 293723 0
Condition category
Condition code
Inflammatory and Immune System 294023 294023 0 0
Allergies
Respiratory 294143 294143 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) The fluticasone group: Receiving active nebulized fluticasone (0.5 mg/2ml; four times a day for one week) and placebo tablets (for seven days).
2) The methylprednisolone group: Receiving active methylprednisolone tablets orally (1 mg/kg/day for 4 days followed by 0.5 mg/kg/day for three more days) in addition to placebo nebules (2 ml; four times a day for one week).
The overall duration of the intervention will be 1 week.
The monitor adherence to the intervention will control by drug tablet return and regular admission to the hospital for the clinical and laboratory evaluation.
Intervention code [1] 290790 0
Treatment: Drugs
Comparator / control treatment
The methylprednisolone group will be the comparator group.
Control group
Active

Outcomes
Primary outcome [1] 293800 0
Comparison of Pulmonary Index Scoring between the fluticasone and methylprednisone group
Timepoint [1] 293800 0
sequential evaluations of Pulmonary Index Scoring will done at the 1st, 4th, 8th, 12th and 24th hours at ER. After 24 hours, if PIS decreased more than 50% of the baseline value, the patient then will discharged and re-evaluated for PIS measurement at 2nd and 7th day. if PIS has not decreased more than 50% patients assessment will be made after 3 hours again and the patients will discharged from the study.
Secondary outcome [1] 311900 0
Changes of total symptom/medication scores: the scoring system was based on a 3-point grading (1 for mild, 2 for moderate, 3 for severe). The same grading system will used for the short acting beta2-agonist requirement.


Timepoint [1] 311900 0
Scors will be evaluated by daily diaries throughout the 1 week of intervention period.
Secondary outcome [2] 312201 0
Assessment for peak expiratory flow by spirometry
Timepoint [2] 312201 0
Daily during the 7 days.



Secondary outcome [3] 312202 0
Assessing the differences of cytokine responses by serum assay


Timepoint [3] 312202 0
At the begining and 7th days of the intervention

Secondary outcome [4] 312498 0
Assessing the difference of percentages of Treg cells by flow cytometry
Timepoint [4] 312498 0
At the begining and the 7th days of the intervention

Eligibility
Key inclusion criteria
Asthma attack patients who have pulmonary index score between 6 and 12 and/or peak expiratory flow of 60-80% predicted after three doses of nebulized salbutamol at Emergency Room (ER).
Minimum age
1 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
children with concomitant cardiopulmonary disease, systemic CS use during the last 2 weeks prior to the exacerbation, admission to hospital (including patients requiring intense effort to breath, altered state of consciousness, bradycardia, room air oxygen saturation of less than 88%)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other design features
Phase
Type of endpoint(s)
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 outside Australia
Country [1] 6533 0
Turkey
State/province [1] 6533 0
Istanbul

Funding & Sponsors
Funding source category [1] 290378 0
University
Name [1] 290378 0
Marmara Universitesi Bilimsel Arastirma Projeleri Koordinatorlugu
Address [1] 290378 0
Marmara Universitesi Rektorlugu

Goztepe Yerleskesi

Fahrettin Kerem Gokay Street, No: 53, Postal code: 34722

Kadikoy/Istanbul/Turkey
Country [1] 290378 0
Turkey
Primary sponsor type
Individual
Name
Safa Baris
Address
Marmara Universitesi Hastanesi

Mimarsinan Caddesi/No:41, postal code: 34660

Pendik/Istanbul/Turkey
Country
Turkey
Secondary sponsor category [1] 289104 0
None
Name [1] 289104 0
Address [1] 289104 0
Country [1] 289104 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
In this study, we will compared the clinical and immunological efficacy of nebulized corticosteroid (CS) to systemic route during treatment of moderate asthma attack in children.
Treatment responses will assessed by monitoring clinical and immunological parameters including; scores of pulmonary index (PIS) and total symptom/medication, peak expiratory flow (PEF) rate as well as cytokine responses and percentages of Treg cells.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53350 0
A/Prof Safa Baris
Address 53350 0
Marmara University Hospital

Pediatric Allergy and Immunology

Fevzi Cakmak Mahallesi, Mimar Sinan Caddesi, No: 41, Postal code: 34660

Pendik/Istanbul/Turkey
Country 53350 0
Turkey
Phone 53350 0
+905052614986
Fax 53350 0
Email 53350 0
safabaris@hotmail.com
Contact person for public queries
Name 53351 0
Prof Ismail Cinel
Address 53351 0
Marmara University Hospital

Pediatric Allergy and Immunology

Fevzi Cakmak Mahallesi, Mimar Sinan Caddesi, No: 41, Postal code: 34660

Pendik/Istanbul/Turkey
Country 53351 0
Turkey
Phone 53351 0
+90 532 4129596
Fax 53351 0
Email 53351 0
cinelismail@yahoo.com
Contact person for scientific queries
Name 53352 0
Prof Isil B Barlan
Address 53352 0
Marmara University Hospital

Pediatric Allergy and Immunology

Fevzi Cakmak Mahallesi, Mimar Sinan Caddesi, No: 41, Postal code: 34660

Pendik/Istanbul/Turkey
Country 53352 0
Turkey
Phone 53352 0
+90542 414 17 15
Fax 53352 0
Email 53352 0
isilbarlan@gmail.com

No information has been provided regarding IPD availability
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