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The Role of a Novel Aminopeptidase-Like Protein in Asthma


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Asthma, Healthy

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Trial Information

The Role of a Novel Aminopeptidase-Like Protein in Asthma


The goal of this exploratory study is to assess the role of a novel aminopeptidase-like
protein during the induction of airway inflammation in asthma. This aminopeptidase-like
protein may be involved in processing of the type I TNF receptor to a soluble form. We
propose to study the role of this aminopeptidase-like protein in the setting of late phase
asthmatic airway inflammatory responses following segmental allergen challenge in mild
allergic asthmatics.

Inclusion Criteria


ASTHMATICS:

Must be between 18 and 65 years of age, male or female, and must be at least 5 feet in
height.

The diagnosis of asthma requires a history of intermittent, reversible expiratory flow
limitation. Patients will have mild-to-moderately severe asthma as defined by a baseline
forced expiratory flow in one second (FEV(1)) greater than 70% of predicted (at least 6
hours after bronchodilator use) and therapy limited to inhaled beta-agonists.

Positive skin prick-puncture test to one or more common aeroallergens.

A positive inhaled methacholine challenge as defined by a decrease in FEV(1) of at least
20% (PC(20)) in response to inhalation of less than 25 mg/ml of methacholine.

A decrease in FEV(1) of at least 20% in response to inhalation of up to 10,000
bioequivalency allergy units (BAU) or allergy units (AU) per ml of a selected common
aeroallergen (house dust mite, cat hair or grasses) or up to 150 Antigen E units per ml of
short ragweed. Asthmatic patients must also demonstrate a late asthmatic response
(defined as a 20% fall from the baseline established following completion of the early
asthmatic response).

Normal complete blood count, PT, PTT, and serum electrolytes, mineral and hepatic panels
(less than 30 ml of blood will be drawn), normal EKG and chest radiograph without acute
pulmonary infiltrates.

Women of childbearing potential must have a negative pregnancy test within 2 weeks prior
to study and willingness to adhere to reliable birth control methods during the study.

Must not have a diagnosis of a pulmonary disorder other than asthma (e.g., chronic
bronchitis, cystic fibrosis, bronchiectasis, HIV-related lymphocytic airway inflammation).

Must not have a baseline FEV(1) of less than 70% predicted.

Must not have respiratory tract infection or asthma exacerbation within 4 weeks of
screening.

Must not use theophylline, oral or inhaled corticosteroids, nedocromil sodium, cromolyn
sodium, zilueton, leukotriene receptor antagonists (e.g., zafirlukast or montelukast), or
anti-cholinergic agents within the prior 3 months. In addition, patients requiring
ongoing therapy with anti-histamines, hydroxyzine, and tricyclic anti-depressants will be
excluded. Research subjects can continue therapy with inhaled beta-agonists during the
study.

No history of anaphylaxis or severe allergic response.

No history of adverse reactions to lidocaine or other local anesthetics.

No history of active inhaled or intravenous drug abuse or alcohol abuse.

Must not have an abnormal EKG or evidence of coronary artery disease.

Must not require chronic anti-coagulant therapy.

Must not use aspirin within 2 weeks of the bronchoscopic study or non-steroidal
anti-inflammatory agents within 2 days of the bronchoscopic study.

No history of cigarette smoking within the past 3 years.

No history of allergy immunotherapy within the past year.

Not allergic to methacholine.

PT or PTT must not be prolonged 2 seconds greater than normal range.

Platelet count must be greater than or equal to 150,000/mm(3).

Must not test positive for human immunodeficiency virus.

RESEARCH VOLUNTEERS:

Must be between 18 and 65 years of age, male or female, and must be at least 5 feet in
height.

A negative inhaled methacholine challenge as defined by the absence of a decrease in
FEV(1) by 20% (PC(20)) in response to inhalation of 25 mg/ml of methacholine.

A negative skin test to a panel of common aeroallergens.

Normal complete blood count, PT, PTT, and serum electrolytes, mineral and hepatic panels
(less than 30 ml of blood will be drawn). Negative hepatitis serology. Normal EKG and
chest radiograph without acute pulmonary infiltrates.

Women of childbearing potential must have a negative pregnancy test within 2 weeks prior
to study and willingness to adhere to reliable birth control methods during the study.

No history of asthma, allergic rhinitis, or atopic dermatitis.

Must not have a diagnosis of a pulmonary disorder other than asthma (e.g., chronic
bronchitis, cystic fibrosis, bronchiectasis, HIV-related lymphocytic airway inflammation).

Must not have a baseline FEV(1) of less than 70% predicted.

Must not have respiratory tract infection or asthma exacerbation within 4 weeks of
screening.

Must not use theophylline, oral or inhaled corticosteroids, nedocromil sodium, cromolyn
sodium, zilueton, leukotriene receptor antagonists (e.g., zafirlukast or montelukast), or
anti-cholinergic agents within the prior 3 months. In addition, patients requiring
ongoing therapy with anti-histamines, hydroxyzine, and tricyclic anti-depressants will be
excluded. Research subjects can continue therapy with inhaled beta-agonists during the
study.

No history of anaphylaxis or severe allergic response.

No history of adverse reactions to lidocaine or other local anesthetics.

No history of active inhaled or intravenous drug abuse or alcohol abuse.

Must not have an abnormal EKG or evidence of coronary artery disease.

Must not require chronic anti-coagulant therapy.

Must not use aspirin within 2 weeks of the bronchoscopic study or non-steroidal
anti-inflammatory agents within 2 days of the bronchoscopic study.

No history of cigarette smoking within the past 3 years.

No history of allergy immunotherapy within the past year.

Not allergic to methacholine.

PT or PTT must not be prolonged 2 seconds greater than normal range.

Platelet count must be greater than or equal to 150,000/mm(3).

Must not test positive for human immunodeficiency virus.

Type of Study:

Observational

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

990075

NCT ID:

NCT00001887

Start Date:

March 1999

Completion Date:

February 2001

Related Keywords:

  • Asthma
  • Healthy
  • Airway Inflammation
  • Allergen Challenge
  • Bronchoscopy
  • Cytokines
  • Receptors
  • Asthma
  • Normal Volunteer
  • Asthma
  • Inflammation

Name

Location

National Heart, Lung and Blood Institute (NHLBI)Bethesda, Maryland  20892