Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose-Response of Salmeterol in Children

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: NCT01907334
Recruitment Status : Completed
First Posted : July 24, 2013
Results First Posted : October 7, 2014
Last Update Posted : October 7, 2014
Sponsor:
Collaborator:
Teva Branded Pharmaceutical Products R&D, Inc.
Information provided by (Responsible Party):
University of Florida

Brief Summary:
To examine whether a breathing test (methacholine challenge using impulse oscillometry) can be used to tell the difference between two different doses of an inhaled drug, salmeterol, delivered by Advair in children with asthma

Condition or disease Intervention/treatment Phase
Asthma Drug: Advair Diskus100/50 µg Drug: Flovent Diskus 100 µg Drug: Methacholine Chloride Drug: Albuterol Phase 4

Detailed Description:

During the study the subject will have to attend 4 study visits: 2 screening visits and 2 treatment visits.

Before each study visit, the subject has to stop using certain asthma medications.

At Screening Visit 1a, the parent/guardian will read and sign the informed consent form to allow the subject to take part in this study. The subject, if appropriate, will be asked to sign the last page to indicate his/her assent to be in the study.

The study coordinator will conduct an interview to find out about the subject's medical history, diseases other than asthma, previous medication and any medication that the subject will take during his/her participation in this study. Vital signs, i.e. blood pressure, heart rate, and respiration, and height and weight will be measured, and an electrocardiogram (ECG) which is a test to measure the electrical activity of the subject's heart, will be performed. The subject will be examined by a Pediatric Pulmonary physician and will be taught the proper way to use a Diskus® inhaler. The subject has to be able to show that he/she can do this correctly.

At Screening Visit 1b, if all of the tests are in the appropriate range the subject will take 2 puffs of Flovent from a Diskus®. One hour later, the subject will perform a breathing test called impulse oscillometry. Essentially, a sound is sent down into the lungs and a computer converts the return sound into a number. Then the subject will begin a breathing test with methacholine, a drug that makes the airways smaller. He/she will begin by inhaling a low dose in a nebulizer and then performing oscillometry. After a 5 minute interval he/she will breathe in increasing doses, up to 6 times or until his/her breathing test increases by 40%. Albuterol will be administered immediately after the end of the challenge and the subject will be monitored until his/her breathing returns to within 20% of where it was before the challenge.

If the methacholine test results are within the appropriate range the subject will be eligible for the treatment phase and will be scheduled for Visit No. 2.

At each treatment visit, the subject will take 2 puffs of study drug from two Diskus® inhalers, either 1 puff of Flovent and 1 puff of Advair, or 1 puff of Advair from two different inhalers. This is done in a blinded manner so the study coordinator does not know which treatment is used each time. There will be a 1 hour wait time after the medication is administered before the methacholine challenge is started. Albuterol will be administered immediately after the end of the challenge and the subject will be monitored until his/her breathing returns to within 20% of where it was before the challenge.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Official Title: Dose-response of Salmeterol Delivered by Advair Diskus in Children: Bioassay by Methacholine Challenge Using Oscillometry as the Endpoint
Study Start Date : August 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014


Arm Intervention/treatment
Active Comparator: Advair Diskus100/50 µg and Advair Diskus 100/50 µg
The Advair Diskus 100/50 µg and Advair Diskus 100/50 µg will be administered in a blinded fashion. One hour after receiving the dose of Advair a methacholine challenge will be performed to determine the PC40R5. After the PC40R5 has been reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects will inhale albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function will be monitored until it has returned to within 20% of that day's baseline R5.
Drug: Advair Diskus100/50 µg
Advair Diskus 100/50 µg
Other Names:
  • fluticasone
  • salmeterol

Drug: Methacholine Chloride
Methacholine Chloride in quadrupling concentrations from 0.25 to 64 mg/mL will be given based upon subject's baseline response.

Drug: Albuterol
Albuterol will be administered at the end of each methacholine challenge.

Active Comparator: Advair Diskus 100/50 µg and Flovent Diskus 100 µg
The Advair Diskus 100/50 µg and Flovent Diskus 100 µg will be administered in a blinded fashion. One hour after receiving the dose of Advair and Flovent a methacholine challenge will be performed to determine the PC40R5. After the PC40R5 has been reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects will inhale albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function will be monitored until it has returned to within 20% of that day's baseline R5.
Drug: Advair Diskus100/50 µg
Advair Diskus 100/50 µg
Other Names:
  • fluticasone
  • salmeterol

Drug: Flovent Diskus 100 µg
Flovent Diskus 100 µg
Other Name: fluticasone

Drug: Methacholine Chloride
Methacholine Chloride in quadrupling concentrations from 0.25 to 64 mg/mL will be given based upon subject's baseline response.

Drug: Albuterol
Albuterol will be administered at the end of each methacholine challenge.




Primary Outcome Measures :
  1. Total Airway Resistance Increase [ Time Frame: 1 to 7 days ]
    concentration of methacholine required to increase total airway resistance by 40% (PC40R5)



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • parent/legal guardian and subject must be able to speak and understand English and patient must be willing and able to give assent to take part in the study
  • diagnosed with asthma for at least 6 months
  • able to demonstrate inhalation technique with study device
  • if taking inhaled corticosteroids, dose must be stable for 2 weeks
  • no significant concomitant medical conditions or abnormal physical findings on screening except for those consistent with asthma and allergic rhinitis
  • airway responsiveness to methacholine with a baseline provocational dose causing an increase of at least 40% in R5 (PC40R5) at no more than 8 mg/mL

Exclusion Criteria:

  • female who has started menstruating
  • past or present history of any allergic reaction to any of the medications or formulations administered in this study
  • prior treatment with systemic corticosteroids in last 30 days or more than 4 courses in previous 12 months
  • use of short-acting beta-agonist more than two times per week in the previous month
  • use of long-acting beta-agonist in the 3 weeks before the first methacholine challenge or during the study
  • change in dosage of inhaled corticosteroids in previous 30 days, nasal steroids in previous 15 days and montelukast in last 7 days
  • history of life-threatening asthma, including loss of consciousness, intubation and/or admission to ICU
  • hospitalization for acute asthma within past year
  • inability to withhold the following medications before methacholine challenges:
  • short-acting beta-agonists at least 6 hours
  • regular long-acting beta-agonists at least 3 weeks
  • inhaled corticosteroid at least 2 hours
  • montelukast at least 24 hours
  • aspirin and non-steroid anti-inflammatory drugs at least 48 hours
  • caffeine at least 4 hours

Information from the National Library of Medicine

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): NCT01907334


Locations
Layout table for location information
United States, Florida
University of Florida Asthma Research Lab
Gainesville, Florida, United States, 32610-0486
Sponsors and Collaborators
University of Florida
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Leslie Hendeles, PharmD University of Florida
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01907334    
Other Study ID Numbers: 38-2013
First Posted: July 24, 2013    Key Record Dates
Results First Posted: October 7, 2014
Last Update Posted: October 7, 2014
Last Verified: October 2014
Keywords provided by University of Florida:
oscillometry
asthma
methacholine
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Albuterol
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Methacholine Chloride
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents