Inhaled fluticasone in acute severe asthma

ISRCTN	ISRCTN96658320
DOI	https://doi.org/10.1186/ISRCTN96658320
Secondary identifying numbers	RES/10/2005

Submission date: 02/07/2007
Registration date: 12/07/2007
Last edited: 09/11/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr K.R. Dhanasekar
Scientific

Department of Pharmacology
Christian Medical College
Thorapadi Post
Bagayam, Tamil Nadu
Vellore
632002
India

Study information

Study design	Randomised, double blind, double dummy, single centre, parallel group design.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	High dose inhaled fluticasone is superior to standard treatment with intravenous hydrocortisone in patients with acute severe asthma.
Ethics approval(s)	The study was approved by Christian Medical College Ethics committee on the 18th October 2005 (ref: IRB(EC)23/10/05).
Health condition(s) or problem(s) studied	Acute severe asthma, acute exacerbation of asthma
Intervention	Baseline Measurements: Subjects, those who are randomised will be asked to perform baseline Peak Expiratory Flow (PEF) and Forced Expiratory Volume at one second (FEV1). Blood samples will be drawn for blood Theophylline level, pre-treatment serum potassium, Haemoglobin (Hb), Total Leucocyte Count (TLC), Differential Leucocyte Count (DLC) and Glucometer Random Blood Sugar (GRBS). Bedside Electrocardiogram (ECG) will be done before initiation of the treatment. Drug dose, route and time of administration: One group will receive two doses of Fluticasone 2 mg via nebulizer half an hour apart and single dose of intravenous (IV) placebo. The other group will receive single dose of Hydrocortisone 200 mg IV and two doses of placebo via nebulizer half an hour apart. In addition, all patients will receive salbutamol 2.5 mg and ipratropium bromide 0.5 mg via nebulizer alternating every 15 minutes for three hours. Monitoring: PEF and FEV1 to be measured at 0, 30, 60, 90, 120, 150 and 180 minutes from the time of administering the drug, for close monitoring of the patient although the primary outcome measurement is at 90th and 180th minute. If there is no improvement at 90th minute, the subject will be withdrawn from the trial and standard care will be given. If there is sign of worsening of the subject's condition from the baseline, at any point of time after the start of the trial, the subject will be immediately admitted into intensive care unit. During the period of drug administration the patient will be continuously monitored for adverse effect. At the end of three hours serum potassium level and GRBS level will be assessed. At the end of three hours, those who fulfilled the discharge criteria will be discharged and the rest will be admitted in the ward for further management. Follow up: At the time of discharge, all subjects will be advised to take Tab. Prednisolone 30 mg Once Daily (OD) and Tab. Ranitidine 150 mg twice daily for seven days along with Metered Dose Inhaler (MDI) Salbutamol 100 mcg two puffs when necessary (PRN) and MDI Fluticasone 250 mcg two puffs twice daily (BD) for one month. All of them will be advised follow up in Pulmonary Medicine Out-Patients Department (OPD) or Pulmonary Function laboratory at one month from the date of admission, to repeat PEF and FEV1. If there is any aggravation of symptoms prior to the day of follow up, all patients are advised to report to the Emergency Department immediately.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Fluticasone
Primary outcome measure	FEV1 and PEF at 90 minutes and 180 minutes from the time of administering the drug.
Secondary outcome measures	1. Symptom assessment, at 90 minutes and180 minutes from the time of administering the drug 2. Adverse effect of fluticasone at 90 minutes and180 minutes from the time of administering the drug
Overall study start date	01/11/2006
Completion date	30/05/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	110
Key inclusion criteria	1. Age between 18 to 55 2. Asthma patients with Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) less than 50% of the predicted 3. Asthmatic for six months or more
Key exclusion criteria	1. Underlying chronic lung disease 2. Fever more than 100.4°F 3. Smoker greater than five pack years 4. Patients with no legal representative or legal representative not willing to give consent 5. Life threatening asthma
Date of first enrolment	01/11/2006
Date of final enrolment	30/05/2008

Locations

Countries of recruitment

India

Study participating centre

Department of Pharmacology

Vellore
632002
India

Sponsor information

Christian Medical College (India)
Government

Bagayam
Thorapadi Post
Tamil Nadu
Vellore
632002
India

Website	http://www.cmch-vellore.edu/
"ROR"	https://ror.org/00c7kvd80

Funders

Funder type

Hospital/treatment centre

Christian Medical College (India) - FLUID research grant (ref: R.C. Min No: 5735, RES/10/2005).

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan