Dose-response of Inhaled Formoterol Using Methacholine Challenge as a Bioassay

University of Florida

Status

Completed

Conditions

Asthma

Treatments

Device: Dry Powder Inhaler (Twisthaler)

Drug: formoterol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00643578

Ivax-65307

Details and patient eligibility

About

The purpose of this study is to find out whether a difference between two doses of formoterol can be detected by methacholine challenge.

Full description

During the screening visit, subjects'vital signs (heart rate, blood pressure and temperature) will be measured and they will perform standard spirometry. If the results of this test are 70% of normal or greater, they will be examined by a physician, and blood (1 teaspoonful) and urine will be collected for routine laboratory tests (CBC and routine urinalysis). If they are a female, a pregnancy test will be performed.

During the second visit, subjects will inhale 1 or 2 doses of formoterol, (Foradil Aerolizer 12 mcg/capsule) a long-acting bronchodilator and 1 hour later, perform a methacholine test.

At the end of the methacholine test, they will be given albuterol to reverse the effects of methacholine. On the third study day, they will repeat the second visit but with the opposite dose of Foradil.

Enrollment

37 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Non-smoking male or female 18 60 years of age, with a previous diagnosis of asthma that has been stable for at least 4 weeks and which is unlikely to exacerbate during the study because of, for example, seasonal allergen exposure. Women of childbearing age must not be pregnant or nursing, and must be using an acceptable method of contraception.
Ability to perform ATS/ERS-acceptable and reproducible spirometry7
Screening FEV1 ≥70% of predicted for height, age, sex, and race when short-acting inhaled bronchodilators are withheld for at least 6 hours
At least a 20% decrease in FEV1 after inhaling ≤4 mg/mL of methacholine (i.e., a PC20 FEV1 ≤4 mg/mL)
Can be taught to use the dry powder device in accordance with the product's medication guide.
If using an oral inhaled or intranasal corticosteroid, dosage must be stable for at least 4 weeks.

Exclusion criteria

Allergy or sensitivity to inhaled methacholine, formoterol or to other β2 agonists
Intolerance to other components of the inhaler or sensitivity to milk proteins
Cigarette smoking in past year or >10 pack-year smoking history
Respiratory tract infection within the last four weeks
History of severe asthma attack requiring hospitalization in the previous 12 months
Short course of oral and/or systemic corticosteroids in the past 4 weeks
Inability to withhold caffeinated beverages for 12 hours or medications for appropriate intervals prior to each methacholine challenge
Require treatment with beta-blockers (administered by any route), MAO inhibitors, tricyclic antidepressants, and/or maintenance therapy with systemic corticosteroids
History and/or presence of pulmonary conditions (including but not limited to cystic fibrosis and bronchiectasis) other than asthma
History of clinically-significant cardiovascular, renal, neurologic, liver or endocrine dysfunction. Patients with well-controlled hypertension, hypercholesterolemia or diabetes will not be excluded.
If female, a positive urine β-HCG test
Known or suspected substance abuse (e.g., alcohol, marijuana, etc.) and/or any other medical or psychological conditions that in the investigator's opinion should preclude study enrollment.