AsthmaPhase 4NCT00867737
Onset of Action of Advair Hydrofluoroalkane (HFA) 115/21 in Comparison to Symbicort Pressurised Metered-Dose Inhalers (pMDI) 160/4.5 Measured by Impulse Oscillometry (IOS)
A Phase 4 study testing Advair HFA MDI 115/21 and Symbicort 160/4.5 pMDI in people with Asthma, run by Allergy and Asthma Center of El Paso at 1 site in United States.
Trial summary
The objectives of this study are to measure Impulse Oscillometry (IOS) in patients with asthma extensively at baseline in patients with mild-to-moderate asthma, treated with as-needed short acting beta agonist only, to measure respiratory resistance and small airway dysfunction accurately and precisely at baseline… Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Asthma
- What is being tested?
- Advair HFA MDI 115/21 and Symbicort 160/4.5 pMDI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of asthma
- Asthma symptoms controlled by short-acting beta agonist as-needed
- Age 12-45 years
Who cannot join
- Severe asthma
- use of oral or inhaled corticosteroids within 30 days of screening
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Allergy and Asthma Center of El Paso
El Paso, Texas, 79925
Rogelio Menendez, MD, 915-591-2080, rmaacep@swbell.net
Rogelio Menendez, MD
About this study
Official title: Onset of Action of Advair HFA 115/21 in Comparison to Symbicort pMDI 160/4.5 Measured by Impulse Oscillometry, IOS.
The objectives of this study are to measure Impulse Oscillometry (IOS) in patients with asthma extensively at baseline in patients with mild-to-moderate asthma, treated with as-needed short acting beta agonist only, to measure respiratory resistance and small airway dysfunction accurately and precisely at baseline, from which to measure onset of action of Advair MDI in comparison with that of Symbicort MDI. Initial screening will assess IOS resistance and small airway dysfunction and its response to short acting beta agonist (SABA). Patients will be selected from among those who manifest a 40% improvement in small airway function assessed by IOS low frequency reactance after SABA compared to baseline. After screening, patients will be randomized to receive either Advair or Symbicort; and will be assessed at randomization before and at several intervals after initial dosing, up to 4 hours. Patients will return again 4 weeks after randomization for extended IOS (and spirometry) testing as done at randomization.
Read the detailed description
Eligibility criteria include age 12-45 years, with current treatment of asthma with as-needed SABA only; and manifesting an acute response to SABA at screening of 40% or greater improvement in IOS low frequency reactance. After inclusion in the protocol, all subjects will receive active treatment, either with Advair or with Symbicort. Outcome measures will include large and small airway resistance and integrated low-frequency reactance calculated directly from IOS measures, and in addition, Large Airway Resistance, Small Airway Resistance and Small Airway Compliance derived from an electrical equivalent respiratory system model. Analysis of IOS data will be done post-testing by a respiratory physiologist, experienced with use of IOS and its analysis and interpretation, blinded to which treatment each individual received. Electrical-equivalent respiratory system model analyses will be done by a biomedical engineer, blinded to which treatment each individual received.
- Conditions
- Asthma
- Being tested
- Advair HFA MDI 115/21, Symbicort 160/4.5 pMDI
- Keywords
- Asthma, Forced Oscillation, Impulse Oscillometry, Electrical-equivalent respiratory system model
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advair HFA MDI 115/21Drug
Also called Advair = fluticasone proprionate plus salmeterol
Two puffs from MDI twice daily for 4 weeks
Symbicort 160/4.5 pMDIDrug
Also called Symbicort = budesonide plus formoterol fumarate
Symbicort 160/4.5 pMDI
Two puffs from MDI twice daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Advair 115/21 MDI | Experimental | Advair HFA 115/21 MDI Intervention = initiate intervention after screening Receives: Drug: Advair HFA MDI 115/21 |
| 2 = Symbicort 160/4.5 | Active comparator | Symbicort initiated after screening Receives: Drug: Symbicort 160/4.5 pMDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated low frequency reactance improvement after initial dosing
Measured: 5, 20, 40, 60, 120, and 240 min
Secondary outcomes (2)
Frequency-dependence of Resistance (R5-R20) after initial dosing
Measured: 5, 20, 40, 60, 120, and 240 min
Model-derived estimates of Large and Small Airway Resistance and Compliance, and their changes after initial dosing
Measured: 5, 20, 40, 60, 120, and 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allergy and Asthma Center of El Paso
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Rogelio Menendez, MD, Principal investigator, Allergy and Asthma Center of El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867737
- Sponsor's protocol ID
- CRT112430
- Status last verified
- Mar 2009
- First submitted
- 23 Mar 2009
- Last updated
- 24 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset of Action of Advair HFA 115/21 in Comparison to Symbicort pMDI 160/4.5 Measured by Impulse Oscillometry, IOS.
- ClinicalTrials.gov ID
- NCT00867737
- Acronym / sponsor ID
- CRT112430
- Conditions
- Asthma
- Keywords
- Asthma, Forced Oscillation, Impulse Oscillometry, Electrical-equivalent respiratory system model
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Allergy and Asthma Center of El PasoUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to measure Impulse Oscillometry (IOS) in patients with asthma extensively at baseline in patients with mild-to-moderate asthma, treated with as-needed short acting beta agonist only, to measure respiratory resistance and small airway dysfunction accurately and precisely at baseline, from which to measure onset of action of Advair MDI in comparison with that of Symbicort MDI. Initial screening will assess IOS resistance and small airway dysfunction and its response to short acting beta agonist (SABA). Patients will be selected from among those who manifest a 40% improvement in small airway function assessed by IOS low frequency reactance after SABA compared to baseline. After screening, patients will be randomized to receive either Advair or Symbicort; and will be assessed at randomization before and at several intervals after initial dosing, up to 4 hours. Patients will return again 4 weeks after randomization for extended IOS (and spirometry) testing as done at randomization.
Detailed description
Eligibility criteria include age 12-45 years, with current treatment of asthma with as-needed SABA only; and manifesting an acute response to SABA at screening of 40% or greater improvement in IOS low frequency reactance. After inclusion in the protocol, all subjects will receive active treatment, either with Advair or with Symbicort. Outcome measures will include large and small airway resistance and integrated low-frequency reactance calculated directly from IOS measures, and in addition, Large Airway Resistance, Small Airway Resistance and Small Airway Compliance derived from an electrical equivalent respiratory system model. Analysis of IOS data will be done post-testing by a respiratory physiologist, experienced with use of IOS and its analysis and interpretation, blinded to which treatment each individual received. Electrical-equivalent respiratory system model analyses will be done by a biomedical engineer, blinded to which treatment each individual received.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advair 115/21 MDI | Experimental | Drug: Advair HFA MDI 115/21Advair HFA 115/21 MDI Intervention = initiate intervention after screening |
| 2 = Symbicort 160/4.5 | Active comparator | Drug: Symbicort 160/4.5 pMDISymbicort initiated after screening |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of asthma
- Asthma symptoms controlled by short-acting beta agonist as-needed
- Age 12-45 years
Key exclusion criteria (2 listed)
- Severe asthma
- use of oral or inhaled corticosteroids within 30 days of screening
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 HFA MDI 115/21Also: Advair = fluticasone proprionate plus salmeterolTwo puffs from MDI twice daily for 4 weeks | Drug | Advair 115/21 MDI |
| Symbicort 160/4.5 pMDIAlso: Symbicort = budesonide plus formoterol fumarateSymbicort 160/4.5 pMDI Two puffs from MDI twice daily for 4 weeks | Drug | 2 = Symbicort 160/4.5 |
Primary outcome
Integrated low frequency reactance improvement after initial dosing
Time frame: 5, 20, 40, 60, 120, and 240 min
2 secondary outcomes
Frequency-dependence of Resistance (R5-R20) after initial dosing
Time frame: 5, 20, 40, 60, 120, and 240 min
Model-derived estimates of Large and Small Airway Resistance and Compliance, and their changes after initial dosing
Time frame: 5, 20, 40, 60, 120, and 240 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2009.
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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.
Rogelio Menendez, MD principal investigator
Allergy and Asthma Center of El Paso
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 HFA MDI 115/21 and Symbicort 160/4.5 pMDI in people with Asthma, run by Allergy and Asthma Center of El Paso 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Mar 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rogelio Menendez, MD (915-591-2080, rmaacep@swbell.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrated low frequency reactance improvement after initial dosing (time frame: 5, 20, 40, 60, 120, and 240 min). 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 24 Mar 2009.