NCT02182700

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at below P25 for phase_3 asthma

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1999

Completed
14.6 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

1.4 years

First QC Date

July 3, 2014

Last Update Submit

July 3, 2014

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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

    60 and 120 min after starting treatment

Secondary Outcomes (4)

  • Number of patients whose PEFR >= 60% within the first or the second hour

    60 and 120 min after start of treatment

  • Hospitalisation period at the Intensive Care Unit (ICU)

    up to 3rd hour after treatment

  • Hospitalisation time at the general ward

    up to 3rd hour after treatment

  • Number of relapses and/or new episodes

    7 days after finishing treatment

Study Arms (1)

Combivent® aerosol

EXPERIMENTAL
Drug: salbutamol sulfate + ipratropium bromide

Interventions

salbutamol sulfate + ipratropium bromideDRUG

120 mcg (salbutamol sulfate) + 20 mcg (ipratropium bromide), inhalation (metered aerosol plus spacer)

Also known as: Combivent® aerosol
Combivent® aerosol

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

AlbuterolIpratropium

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 8, 2014

Study Start

July 1, 1998

Primary Completion

December 1, 1999

Last Updated

July 8, 2014

Record last verified: 2014-07