AsthmaPhase 4NCT01907334
Dose-Response of Salmeterol in Children
A Phase 4 study testing Advair Diskus100/50 µg, Flovent Diskus 100 µg and Methacholine Chloride in people with Asthma, run by University of Florida at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Advair Diskus100/50 µg, Flovent Diskus 100 µg and Methacholine Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Asthma Research Lab
Gainesville, Florida, 32610-0486
About this study
Official title: Dose-response of Salmeterol Delivered by Advair Diskus in Children: Bioassay by Methacholine Challenge Using Oscillometry as the Endpoint
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
Read the 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.
- Conditions
- Asthma
- Being tested
- Advair Diskus100/50 µg, Flovent Diskus 100 µg, Methacholine Chloride, Albuterol
- Keywords
- oscillometry, asthma, methacholine
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advair Diskus100/50 µgDrug
Also called fluticasone, salmeterol
Advair Diskus 100/50 µg
Flovent Diskus 100 µgDrug
Also called fluticasone
Flovent Diskus 100 µg
Methacholine ChlorideDrug
Methacholine Chloride in quadrupling concentrations from 0.25 to 64 mg/mL will be given based upon subject's baseline response.
AlbuterolDrug
Albuterol will be administered at the end of each methacholine challenge.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Advair Diskus100/50 µg; Drug: Flovent Diskus 100 µg; Drug: Methacholine Chloride; Drug: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Airway Resistance Increase
concentration of methacholine required to increase total airway resistance by 40% (PC40R5)
Measured: 1 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Responsible party
- Sponsor
- Investigators
- Leslie Hendeles, PharmD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907334
- Sponsor's protocol ID
- 38-2013
- Status last verified
- Oct 2014
- First submitted
- 28 Jun 2013
- Last updated
- 7 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response of Salmeterol Delivered by Advair Diskus in Children: Bioassay by Methacholine Challenge Using Oscillometry as the Endpoint
- ClinicalTrials.gov ID
- NCT01907334
- Acronym / sponsor ID
- 38-2013
- Conditions
- Asthma
- Keywords
- oscillometry, asthma, methacholine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- Aug 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Posted 7 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advair Diskus100/50 µg and Advair Diskus 100/50 µg | Active comparator | Drug: Advair Diskus100/50 µg, Drug: Methacholine Chloride, Drug: AlbuterolThe 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. |
| Advair Diskus 100/50 µg and Flovent Diskus 100 µg | Active comparator | Drug: Advair Diskus100/50 µg, Drug: Flovent Diskus 100 µg, Drug: Methacholine Chloride, Drug: AlbuterolThe 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. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advair Diskus100/50 µgAlso: fluticasone, salmeterolAdvair Diskus 100/50 µg | Drug | Advair Diskus 100/50 µg and Flovent Diskus 100 µg, Advair Diskus100/50 µg and Advair Diskus 100/50 µg |
| Flovent Diskus 100 µgAlso: fluticasoneFlovent Diskus 100 µg | Drug | Advair Diskus 100/50 µg and Flovent Diskus 100 µg |
| Methacholine ChlorideMethacholine Chloride in quadrupling concentrations from 0.25 to 64 mg/mL will be given based upon subject's baseline response. | Drug | Advair Diskus 100/50 µg and Flovent Diskus 100 µg, Advair Diskus100/50 µg and Advair Diskus 100/50 µg |
| AlbuterolAlbuterol will be administered at the end of each methacholine challenge. | Drug | Advair Diskus 100/50 µg and Flovent Diskus 100 µg, Advair Diskus100/50 µg and Advair Diskus 100/50 µg |
Primary outcome
Total Airway Resistance Increase
Time frame: 1 to 7 days
concentration of methacholine required to increase total airway resistance by 40% (PC40R5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Hendeles, PharmD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Advair Diskus100/50 µg, Flovent Diskus 100 µg and Methacholine Chloride in people with Asthma, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Airway Resistance Increase (time frame: 1 to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2014.