Comparative Study on the Efficacy and Safety of Procaterol Versus Salbutamol Given Via Metered Dose Inhaler With Spacer in the Management of Acute Asthma Attack in the Emergency Room

NCT01091337 | Completed Phase 4

• 1 other identifier: KOIAA-MPT-2005-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety of inhaled procaterol (Meptin Air) versus inhaled salbutamol as metered dose inhaler (MDI) reliever of acute exacerbation of asthma not in imminent respiratory failure.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• To evaluate the bronchodilator efficacy of inhaled procaterol (Meptin Air) vs. inhaled salbutamol used as MDI reliever of acute exacerbation of asthma in the ER.

  < 12 hours

Secondary Outcomes (1)

• To evaluate the safety of procaterol MDI (Meptin Air) versus salbutamol MDI in the management of acute exacerbation of asthma in terms of adverse side effects such as palpitations, tachycardia, tremor, and hypokalemia.

  < 12 hours

Study Arms (2)

Procaterol

EXPERIMENTAL

Procaterol(Meptin Air) MDI, 20 ug or 2 puffs every 20 minutes \+ Hydrocortisone, 100 mg IV shall be given immediately at start of treatment

Drug: Procaterol

Salbutamol

ACTIVE COMPARATOR

Salbutamol(Ventolin Inhaler) MDI, 40 ug or 4 puffs every 20 minutes + Hydrocortisone, 100 mg IV shall be given immediately at start of treatment

Drug: Salbutamol

Interventions

Procaterol DRUG

Procaterol(Meptin Air) MDI, 20 ug or 2 puffs every 20 minutes \+ Hydrocortisone, 100 mg IV shall be given immediately at start of treatment

Also known as: Meptin Air

Procaterol

Salbutamol DRUG

Salbutamol(Ventolin Inhaler) MDI, 40 ug or 4 puffs every 20 minutes + Hydrocortisone, 100 mg IV shall be given immediately at start of treatment

Also known as: Ventolin Inhaler

Salbutamol

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 20 years old and above who are brought to the Emergency Room (ER) with acute bronchospasm
• Diagnosed cases of bronchial asthma based on history, physical examination and pulmonary function test
• Patients maintained on inhaled steroids who have no active medical problems (such as pulmonary TB, cardiac and renal diseases) aside from asthma
• Presence of known risk factors for asthma mortality does not disqualify patients from the study unless they are in impending respiratory failure
• All patients must sign the informed consent form

You may not qualify if:

• Patients who are in respiratory distress consistent with severe exacerbation requiring intensive care hospital admission
• Who had intake of oral bronchodilator 6 hrs prior to consult
• Who had intake of oral steroids within the last 24 hrs
• Those with positive history of allergy and hypersensitivity to procaterol and salbutamol
• Patients who are diagnosed or clinically suspected to have COPD (ever-smokers with \>10 pack-years smoking history or those exposed to workplaces where there is a heavy smoke load)
• Presence of concurrent disease/diseases that may aggravate asthma thereby delaying bronchodilator response (e.g., pneumonia, pulmonary congestion and others)
• Patients with other medical conditions which are serious enough to warrant immediate concurrent therapy during the 1 hour study and/or whose condition can be adversely affected by the treatment given (like uncontrolled diabetes, renal failure and hepatic insufficiency)
• Severe asthma with a lack of response to initial therapy in the emergency department or worsening asthma despite adequate therapy.
• Presence of confusion, drowsiness, other signs of impending respiratory arrest, or loss of consciousness
• Wood-Downe's clinical asthma scoring score of \>5 (see table 2 below)
• Any patient who is currently participating in other drug trials and/or having participated in other drug trials for less than 1 month of termination of the trial are excluded
• Patients who have previously participated in this study are excluded

Sponsors & Collaborators

• Otsuka Pharmaceutical, Inc., Philippines: lead

Study Sites (1)

Philippine General Hospital

Manila, Philippines

Location

MeSH Terms

Conditions

Asthma

Interventions

Procaterol; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenethylamines; Ethylamines

Study Officials

• Camilo Roa, MD

  Philippine General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 24, 2010
• Study Start: May 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 24, 2010

Record last verified: 2010-03

Locations

PH (1)