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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

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ClinicalTrials.gov Identifier: NCT01091337
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : March 24, 2010
Sponsor:
Information provided by:
Otsuka Pharmaceutical, Inc., Philippines

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Procaterol Drug: Salbutamol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study on the Efficacy and Safety of Procaterol vs Salbutamol Given Via Metered Dose Inhaler With Spacer in the Management of Acute Asthma Attack in the Emergency Room
Study Start Date : May 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Procaterol

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

Procaterol(Meptin Air) MDI, 20 ug or 2 puffs every 20 minutes

+ Hydrocortisone, 100 mg IV shall be given immediately at start of treatment

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


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: < 12 hours ]

Secondary Outcome Measures :
  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. [ Time Frame: < 12 hours ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • The NIH Working Group on Asthma and Pregnancy has recommended that pregnant asthmatics are treated as aggressively as non-pregnant patients particularly during acute asthmatic attack. , Bronchodilators (except for epinephrine which is not in this study) have been found safe in pregnancy with a risk class of B and C. For these reasons, pregnancy by itself is not an exclusion criterion in this study and a pregnancy test will not be required for those who are in the childbearing age group. Requiring the test will unnecessarily delay the treatment for acute asthma. However, those who are suspected to be suffering from pregnancy-related complications like vaginal bleeding, premature labor, pre-eclampsia and others, are excluded.

  • Severe Acute Asthma Attack, a reason for patient exclusion, shall be defined in this study as the presence of any one of the following criteria:

    1. Severe asthma with a lack of response to initial therapy in the emergency department or worsening asthma despite adequate therapy.
    2. Presence of confusion, drowsiness, other signs of impending respiratory arrest, or loss of consciousness
    3. 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091337


Locations
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Philippines
Philippine General Hospital
Manila, Philippines
Sponsors and Collaborators
Otsuka Pharmaceutical, Inc., Philippines
Investigators
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Principal Investigator: Camilo Roa, MD Philippine General Hospital
More Information
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Responsible Party: Dr. Camilo Roa, MD / Study Principal Investigator, Philippine General Hospital
ClinicalTrials.gov Identifier: NCT01091337     History of Changes
Other Study ID Numbers: KOIAA-MPT-2005-01
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: March 2010
Additional relevant MeSH terms:
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Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
 Hydrocortisone hemisuccinate
Albuterol
Procaterol
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists