Evaluation of the Effect of Levalbuterol on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma

NCT00320034 | Completed Phase 2

• 1 other identifier: SRC 192
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer, albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol which are mirror images of each other i.e. R-and S- isomers. The investigational treatments are R-albuterol and S-albuterol. R-albuterol ( levalbuterol) has been shown to have a slightly better bronchodilator effect as compared to the racemic albuterol and is well- tolerated in patients. However it is still not clear whether the S-isomer has no effect or has a harmful effect on the airways. The purpose of this study is to compare the effects of the R- and S- isomers on allergen induced airway inflammation in subjects with mild atopic asthma. This will give us a better idea as to whether the routine use of levalbuterol is superior to racemic albuterol.

Conditions

Asthma

Keywords

levalbuterol; asthma; allergen provocation; airway inflammation; clinical trial

Outcome Measures

Primary Outcomes (1)

• The change in airway eosinophil number (% and absolute numbers) following an allergen inhalation.

Secondary Outcomes (6)

• Changes in:

• PC20 methacholine

• Allergen-induced early and late asthma responses

• Airway eosinophil activation (EG-2+ eosinophils)

• Levels of IL-5, RANTES, and eotaxin in sputum

Interventions

R-albuterol, S-albuterol DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female (medically or surgically postmenopausal or practicing an accepted form of barrier or hormonal contraception) subjects age 18-55.
• Stable, mild atopic asthma with forced expiratory volume in one second (FEV1.0) greater than 70% of predicted for age and height, and not requiring any medical treatment other than short acting inhaled beta-agonists as needed.
• No recent or significant history of cigarette smoking (no cigarettes within six months prior to entry into the study; less than 10 pack-years cumulative history of cigarette smoking).
• Peak decrease in FEV1 in both early (0-2 hour) and late (3-7 hour) allergen-provoked response of \> 15% compared with the baseline (pre-allergen challenge) spirometric determination.
• Signed written informed consent to participate in the protocol; ability to return to the outpatient clinic for repeated clinic visits.
• No history of asthma exacerbations or acute intercurrent respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) for a six week period preceding entry into the screening phase of the study.

You may not qualify if:

• Significant gastrointestinal (including hepatic), hematological, cardiovascular, cerebrovascular or other body system disorder.
• History of an acute exacerbation, or of a respiratory tract infection at any time during the past 6 weeks.
• Baseline AST or ALT (indicators of liver damage) greater than twice the upper limit of the normal range for the local laboratory.
• History of allergy or hypersensitivity to short-acting beta-agonists.
• Inability to discontinue asthma medications for the duration of the study or receipt of oral or inhaled corticosteroids or leukotriene receptor antagonist in the three weeks prior to entry into the screening phase of the study.
• Recent (within the past 2 months) or planned (within the study period) lung volume reduction surgery.
• Psychosis, alcoholism, active substance abuse, or any personality disorder which would make compliance with this protocol problematic.
• Pregnant or nursing females.
• Any other medical or social condition which, in the opinion of the investigator, could confound the interpretation of the data derived from this study.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Sumitomo Pharma America, Inc.: collaborator

Related Publications (2)

• Lotvall J, Palmqvist M, Arvidsson P, Maloney A, Ventresca GP, Ward J. The therapeutic ratio of R-albuterol is comparable with that of RS-albuterol in asthmatic patients. J Allergy Clin Immunol. 2001 Nov;108(5):726-31. doi: 10.1067/mai.2001.119152.

  PMID: 11692096 BACKGROUND

• Handley DA, Tinkelman D, Noonan M, Rollins TE, Snider ME, Caron J. Dose-response evaluation of levalbuterol versus racemic albuterol in patients with asthma. J Asthma. 2000 Jun;37(4):319-27. doi: 10.3109/02770900009055455.

  PMID: 10883742 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Parameswaran Nair, MD

  Firestone Institute for Respiratory Health, St. Joseph's Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: April 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: November 1, 2009
• Last Updated: March 2, 2011

Record last verified: 2009-07