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Efficacy and Safety of Combivent® Aerosol and Spacer, in Adult Patients With Moderate to Severe Asthma Crisis

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
salbutamol sulfate + ipratropium bromide
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients with a diagnosis of asthma according to the American Thoracic Society (ATS) presenting at the emergency room with an acute moderate and/or severe asthma attack
  • Patients aged between18 to 40 years
  • Patients able to perform spirometry (PEFR and FEV1)
  • PEFR < 60% and > 25 % of predicted normal value or a FEV1 <= 60% of predicted normal value
  • Patients able to sign witnessed informed consent

Exclusion Criteria:

  • Patients with very severe or life threatening obstruction, manifested by:

    • Cyanosis of tongue and lips
    • Confusion, drowsiness, coma or exhaustion
    • Silent chest on auscultation or weak respiratory effort
    • PEFR < 25% the predicted normal value
    • Bradycardia (of less 60 beats/min)
  • Patients with a smoking history of more than 10 pack/years
  • Patients with chronic obstructive pulmonary disease (COPD)
  • Patients on treatment for or suspected as having glaucoma
  • Patients with uncontrolled hypertension
  • Patients with known allergy or contra-indications to either salbutamol, ipratropium or hydrocortisone or their excipients
  • Female patients known or suspected to be pregnant or nursing
  • Patients known or suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum
  • Patients with a history of chest surgery
  • Patients with other respiratory conditions if diagnosed. These included pulmonary fibrosis, bronchiectasis, cystic fibrosis, pulmonary tuberculosis, pulmonary complications of AIDS, lung cancer
  • Patients requiring drugs for the treatment of the acute asthma attack other than the study drug, hydrocortisone or oxygen
  • Patients who have previously recruited into this study
  • Patients who have been on other investigational drugs within three months prior to study entry
  • Patients with acute myocardial infarction, pulmonary edema or other life threatening disease, which in the judgment of the ER (Emergency room) physician precluded entry into the study
  • Patients with obvious or previous diagnosed serious hepatic or renal impairment or bladder neck obstruction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Combivent® aerosol

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of patients discharged with a peak flow expiratory flow rate (PEFR) >= 70% predicted normal value at the end of the first and the second treatment

    Secondary Outcome Measures

    Number of patients whose PEFR >= 60% within the first or the second hour
    Hospitalisation period at the Intensive Care Unit (ICU)
    Hospitalisation time at the general ward
    Number of relapses and/or new episodes

    Full Information

    First Posted
    July 3, 2014
    Last Updated
    July 3, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02182700
    Brief Title
    Efficacy and Safety of Combivent® Aerosol and Spacer, in Adult Patients With Moderate to Severe Asthma Crisis
    Official Title
    Open Study on the Efficacy and Safety of Combivent® Aerosol (120 mcg Salbutamol Sulfate Plus 20 mcg Ipratropium Bromide) + Spacer, 12 to 24 Puffs, in Adult Patients With Moderate to Severe Asthma Crisis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Terminated
    Study Start Date
    July 1998 (undefined)
    Primary Completion Date
    December 1999 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    Brief Summary
    Study to evaluate the bronchodilator efficacy and safety of a fixed combination of salbutamol sulfate (120 mcg) + ipratropium bromide (20mcg) (Combivent® MDI) in aerosol plus spacer in adult patients with moderate-to-severe asthma crisis who arrived at the emergency room.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Combivent® aerosol
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    salbutamol sulfate + ipratropium bromide
    Other Intervention Name(s)
    Combivent® aerosol
    Intervention Description
    120 mcg (salbutamol sulfate) + 20 mcg (ipratropium bromide), inhalation (metered aerosol plus spacer)
    Primary Outcome Measure Information:
    Title
    Number of patients discharged with a peak flow expiratory flow rate (PEFR) >= 70% predicted normal value at the end of the first and the second treatment
    Time Frame
    60 and 120 min after starting treatment
    Secondary Outcome Measure Information:
    Title
    Number of patients whose PEFR >= 60% within the first or the second hour
    Time Frame
    60 and 120 min after start of treatment
    Title
    Hospitalisation period at the Intensive Care Unit (ICU)
    Time Frame
    up to 3rd hour after treatment
    Title
    Hospitalisation time at the general ward
    Time Frame
    up to 3rd hour after treatment
    Title
    Number of relapses and/or new episodes
    Time Frame
    7 days after finishing treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female patients with a diagnosis of asthma according to the American Thoracic Society (ATS) presenting at the emergency room with an acute moderate and/or severe asthma attack Patients aged between18 to 40 years Patients able to perform spirometry (PEFR and FEV1) PEFR < 60% and > 25 % of predicted normal value or a FEV1 <= 60% of predicted normal value Patients able to sign witnessed informed consent Exclusion Criteria: Patients with very severe or life threatening obstruction, manifested by: Cyanosis of tongue and lips Confusion, drowsiness, coma or exhaustion Silent chest on auscultation or weak respiratory effort PEFR < 25% the predicted normal value Bradycardia (of less 60 beats/min) Patients with a smoking history of more than 10 pack/years Patients with chronic obstructive pulmonary disease (COPD) Patients on treatment for or suspected as having glaucoma Patients with uncontrolled hypertension Patients with known allergy or contra-indications to either salbutamol, ipratropium or hydrocortisone or their excipients Female patients known or suspected to be pregnant or nursing Patients known or suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum Patients with a history of chest surgery Patients with other respiratory conditions if diagnosed. These included pulmonary fibrosis, bronchiectasis, cystic fibrosis, pulmonary tuberculosis, pulmonary complications of AIDS, lung cancer Patients requiring drugs for the treatment of the acute asthma attack other than the study drug, hydrocortisone or oxygen Patients who have previously recruited into this study Patients who have been on other investigational drugs within three months prior to study entry Patients with acute myocardial infarction, pulmonary edema or other life threatening disease, which in the judgment of the ER (Emergency room) physician precluded entry into the study Patients with obvious or previous diagnosed serious hepatic or renal impairment or bladder neck obstruction

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1012/1012.32_U02-3140.pdf
    Description
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    Efficacy and Safety of Combivent® Aerosol and Spacer, in Adult Patients With Moderate to Severe Asthma Crisis

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