Dose-response of Inhaled Formoterol Using Methacholine Challenge as a Bioassay
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00643578 |
Recruitment Status
:
Completed
First Posted
: March 26, 2008
Results First Posted
: November 18, 2011
Last Update Posted
: December 5, 2011
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: formoterol Device: Dry Powder Inhaler (Twisthaler) | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | A Pilot Study to Evaluate the Dose-response of Inhaled Formoterol to Inhibit Airway Responsiveness to Methacholine in Patients With Mild Asthma |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | January 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 2
a single dose of 24 mcg of formoterol
|
Drug: formoterol
a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
Device: Dry Powder Inhaler (Twisthaler)
subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose
|
Active Comparator: 1
a single dose of 12 mcg of formoterol
|
Drug: formoterol
a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
Device: Dry Powder Inhaler (Twisthaler)
subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose
|
- Post-dose PC20 [ Time Frame: 3-7 days after visits 1 and 2 ]The PC20 is the provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second.
- FEV1 [ Time Frame: 1 hour after dose ]The forced expiratory volume in the first second, expressed as a percent predicted.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643578
United States, Florida | |
University of Florida Asthma Research Lab | |
Gainesville, Florida, United States, 32610-0486 |
Principal Investigator: | Leslie Hendeles, PharmD | University of Florida |
Publications:
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00643578 History of Changes |
Other Study ID Numbers: |
Ivax-65307 |
First Posted: | March 26, 2008 Key Record Dates |
Results First Posted: | November 18, 2011 |
Last Update Posted: | December 5, 2011 |
Last Verified: | November 2011 |
Keywords provided by University of Florida:
formoterol methacholine challenge |
Additional relevant MeSH terms:
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Formoterol Fumarate Methacholine Chloride Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Asthmatic Agents Respiratory System Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Miotics Parasympathomimetics Bronchoconstrictor Agents Muscarinic Agonists Cholinergic Agonists Cholinergic Agents |