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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
Sex
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
3/01/2014
Actual
3/01/2014
Date of last participant enrolment
Anticipated
20/09/2014
Actual
20/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
100
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
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
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
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
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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNebulized fluticasone propionate, a viable alternative to systemic route in the management of childhood moderate asthma attack: A double-blind, double-dummy study.2015https://dx.doi.org/10.1016/j.rmed.2015.07.007
N.B. These documents automatically identified may not have been verified by the study sponsor.