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Trial record 37 of 151 for:    Ipratropium OR atrovent

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

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ClinicalTrials.gov Identifier: NCT02182700
Recruitment Status : Terminated
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 3, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date July 8, 2014
Study Start Date  ICMJE July 1998
Actual Primary Completion Date December 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2014)
  • Number of patients whose PEFR >= 60% within the first or the second hour [ Time Frame: 60 and 120 min after start of treatment ]
  • Hospitalisation period at the Intensive Care Unit (ICU) [ Time Frame: up to 3rd hour after treatment ]
  • Hospitalisation time at the general ward [ Time Frame: up to 3rd hour after treatment ]
  • Number of relapses and/or new episodes [ Time Frame: 7 days after finishing treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Combivent® Aerosol and Spacer, in Adult Patients With Moderate to Severe Asthma Crisis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Drug: salbutamol sulfate + ipratropium bromide
120 mcg (salbutamol sulfate) + 20 mcg (ipratropium bromide), inhalation (metered aerosol plus spacer)
Other Name: Combivent® aerosol
Study Arms  ICMJE Experimental: Combivent® aerosol
Intervention: Drug: salbutamol sulfate + ipratropium bromide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 3, 2014)
47
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02182700
Other Study ID Numbers  ICMJE 1012.32
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP