Condition category
Respiratory
Date applied
02/07/2007
Date assigned
12/07/2007
Last edited
09/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr K.R. Dhanasekar

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RES/10/2005

Study information

Scientific title

Acronym

Study hypothesis

High dose inhaled fluticasone is superior to standard treatment with intravenous hydrocortisone in patients with acute severe asthma.

Ethics approval

The study was approved by Christian Medical College Ethics committee on the 18th October 2005 (ref: IRB(EC)23/10/05).

Study design

Randomised, double blind, double dummy, single centre, parallel group design.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Fluticasone

Primary outcome measures

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 trial start date

01/11/2006

Overall trial end date

30/05/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

110

Participant 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

Recruitment start date

01/11/2006

Recruitment end date

30/05/2008

Locations

Countries of recruitment

India

Trial participating centre

Department of Pharmacology
Vellore
632002
India

Sponsor information

Organisation

Christian Medical College (India)

Sponsor details

Bagayam
Thorapadi Post
Tamil Nadu
Vellore
632002
India

Sponsor type

Government

Website

http://www.cmch-vellore.edu/

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes