Dose-Response of Salmeterol in Children

NCT01907334 | Completed Phase 4 Results

• 1 other identifier: 38-2013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma

Keywords

oscillometry; asthma; methacholine

Outcome Measures

Primary Outcomes (1)

• Total Airway Resistance Increase

  concentration of methacholine required to increase total airway resistance by 40% (PC40R5)

  1 to 7 days

Study Arms (2)

Advair Diskus100/50 µg and Advair Diskus 100/50 µg

ACTIVE COMPARATOR

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; Drug: Methacholine Chloride; Drug: Albuterol

Advair Diskus 100/50 µg and Flovent Diskus 100 µg

ACTIVE COMPARATOR

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; Drug: Flovent Diskus 100 µg; Drug: Methacholine Chloride; Drug: Albuterol

Interventions

Advair Diskus100/50 µg DRUG

Advair Diskus 100/50 µg

Also known as: fluticasone, salmeterol

Advair Diskus 100/50 µg and Flovent Diskus 100 µg; Advair Diskus100/50 µg and Advair Diskus 100/50 µg

Flovent Diskus 100 µg DRUG

Flovent Diskus 100 µg

Also known as: fluticasone

Advair Diskus 100/50 µg and Flovent Diskus 100 µg

Methacholine Chloride DRUG

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

Advair Diskus 100/50 µg and Flovent Diskus 100 µg; Advair Diskus100/50 µg and Advair Diskus 100/50 µg

Albuterol DRUG

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

Advair Diskus 100/50 µg and Flovent Diskus 100 µg; Advair Diskus100/50 µg and Advair Diskus 100/50 µg

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

University of Florida Asthma Research Lab

Gainesville, Florida, 32610-0486, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Salmeterol Xinafoate; Methacholine Chloride; Albuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Methacholine Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Results Point of Contact

• Title: Leslie Hendeles, PharmD
• Organization: University of Florida

hendeles@cop.ufl.edu

352-273-6027

Study Officials

• Leslie Hendeles, PharmD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 24, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 7, 2014
• Results First Posted: October 7, 2014

Record last verified: 2014-10

Locations

US (1)