A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation

NCT00583778 | Completed Results DMC

• 1 other identifier: IRB04-00127
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double blind, controlled clinical trail testing whether three doses of 1.25 mg of nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone every 20 minutes. The primary hypothesis of this study is that three doses of 1.25 mg of nebulized levalbuterol in combination with three doses of 0.5mg of nebulized ipratropium will lead to greater bronchodilation than that achieved by three doses of nebulized 1.25 mg of levalbuterol alone every 20 minutes. The secondary hypothesis is that the treatment combination of levalbuterol and ipratropium will lead to fewer hospitalizations than levalbuterol alone in patients with acute asthma exacerbation. Other secondary objectives include (1) evaluating the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and FEV1, (2) the relationship between baseline (S)- albuterol levels and (R)- albuterol levels on presentation and change in FEV1,(3) time to event analysis for an improvement of 15%, 20%, 30%, 40%, and 50% in FEV1 from initial presentation value, (4) analysis of FEV1 at discharge.

Conditions

Asthma

Keywords

Asthma; Bronchodilators; Levalbuterol; Ipratropium

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Bronchodilation

  Measure FEV-1 in participants immediately prior to treatment and 60 minutes after final treatment to determine improvement in bronchodilation after 1.25mg nebulized levalbuterol + 0.5mg nebulized ipratropium administered every 20 minutes for a total of 3 doses versus bronchodilation after 1.25mg nebulized levalbuterol administered every 20 minutes for a total of 3 doses. FEV-1 measurements were obtained using a hand held spirometer. A difference in 12% of median FEV-1 measures between the two groups was considered clinically significant. Patients were called 14 days after their ED visit to assess relapse or recurrence of acute asthma exacerbation. In addition, a chart review was performed to assess relapse or recurrence of acute asthma exacerbation, as well as determine hospital length of stay in those patients who required admission after the initial visit.

  FEV-1 measured Immediately before treatment dose 1 & 60 minutes after completion of treatment dose 3. Assessment of relapse or recurrence were determined at day 14 after the ED visit.

• Change in FEV-1 % Predicted Over Time

  Primary Outcome- the difference in FEV-1at 60 minutes between participants who received Levalbuterol 1.25 mg x 3 vs participants who received Levalbuterol 1.25 mg x3 + Ipratropium 0.5 mg x3

  60 minutes

Study Arms (2)

Levalbuterol

ACTIVE COMPARATOR

levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline)

Drug: ipratropium

Levalbuterol plus ipratropium

EXPERIMENTAL

ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses

Drug: ipratropium

Interventions

ipratropium DRUG

0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses

Levalbuterol; Levalbuterol plus ipratropium

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• history of asthma
• FEV1 \> 50% of predicted for their height, age, gender and race upon presentation to the ED
• no other cause of wheezing or shortness of breath except for asthma as determined by the Investigator
• no history of glaucoma
• no Ipratropium or other anticholinergics within 6 hours of study

You may not qualify if:

• subjects who, in the investigator's opinion, have life-threatening asthma requiring emergent intervention precluding the ability to complete the treatments during the treatment period
• based upon history or physical exam in the ED orClinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema
• subject with a known sensitivity to levalbuterol or racemic albuterol
• known 20 pack year smoker
• use of ipratropium 6 hours prior to presenting to the ED
• subject who may be pregnant or is pregnant es evidenced by pregnancy test

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Dr. Rita Cydulka
• Organization: MetroHealth Medical Center

rcydulka@gmail.com

216-778-7800

Study Officials

• Rita K Cydulkla, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency medicine physician

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: August 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 16, 2022
• Results First Posted: May 16, 2022

Record last verified: 2022-05

Locations

US (1)