Nebulized fluticasone propionate, a viable alternative to systemic route in the management of childhood moderate asthma attack: A double-blind, double-dummy study

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000096550
• Date of registration: 04/02/2015
• Prospective Registration: No
• Primary sponsor: Safa Baris
• 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
• Date of first enrolment: 03/01/2014
• Target sample size: 100
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000096550.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);

Countries of recruitment

Turkey

Contacts

• Name: Prof Isil B Barlan

• Name: Prof Ismail Cinel

Key inclusion & exclusion criteria

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).
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%)

Age minimum: 1 Years
Age maximum: 16 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Respiratory - Asthma

Asthma attack;
Asthma attack

Inflammatory and Immune System - Allergies

Intervention(s)

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.

Primary Outcome(s)

Comparison of Pulmonary Index Scoring between the fluticasone and methylprednisone group[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(s)

Assessing the difference of percentages of Treg cells by flow cytometry
[At the begining and the 7th days of the intervention]

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.


[Scors will be evaluated by daily diaries throughout the 1 week of intervention period.]

Assessing the differences of cytokine responses by serum assay


[At the begining and 7th days of the intervention

]

Assessment for peak expiratory flow by spirometry[Daily during the 7 days.



]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Marmara Universitesi Bilimsel Arastirma Projeleri Koordinatorlugu