AsthmaPhase 4WSMR2NCT00915538

Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus)

A Phase 4 study testing pMDI budesonide/formotrol 160/4.5 is in group 1 and Symbicort 160/4.5 plus Aerochamber Plus included in group 2 in people with Asthma, run by Western Sky Medical Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Asthma
What is being tested?: pMDI budesonide/formotrol 160/4.5 is in group 1 and Symbicort 160/4.5 plus Aerochamber Plus included in group 2
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Jul 2009to Aug 2009
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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Asthma with 15% or more increase in Forced expiratory volume at 1 second (FEV-1) after 180-360 mcg of albuterol pMDI

Who cannot join

Any illness or condition which might place subject at risk in the study;e.g. some cardiovascular disorders Inability to understand and sign informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Western Sky Medical Research
El Paso, Texas, 79903

Other trials in United States

About this study

Official title: A Comparison of the Bronchodilating Activity of Symbicort Pressure Metered Dose Inhaler (pMDI) 160/4.5 Used in the Conventional Manner and With a Valved Spacer Holding Chamber (Aerochamber Plus)

This study will compare the amount of bronchial tube relaxation from the Formoterol medicine contained in the Symbicort pressure Metered Dose Inhaler(pMDI)(a combination of Budesonide, a steroid, and Formoterol, a drug which relaxes the bronchial smooth muscle. The comparison will be using the pMDI in the usual fashion to the pMDIs and a spacer which allows more time for breathing in the medication. Breathing tests will be measured over a 12 hour period for the comparison.

Read the detailed description

Sixteen subjects will receive treatment in a cross-over design. They will inhale Symbicort 160/4.5 two inhalations in the manner prescribed in the approved package insert. The second intervention will be the inhalation of Symbicort 160/4.5 two inhalations through a valved holding chamber (Aero Chamber Plus). Breathing tests including spirometry will be measured at various time periods over a 12-hour time frame in each intervention. Comparison will be made of the two periods to demonstrate that the use of the valved holding chamber does not adversely affect the bronchodilation of the formoterol component of the combination drug.

Conditions: Asthma
Being tested: pMDI budesonide/formotrol 160/4.5 is in group 1, Symbicort 160/4.5 plus Aerochamber Plus included in group 2
Keywords: Asthma, Formoterol, Long Acting Beta Adrenergic Bronchodilator, Symbicort, Aerochamber
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pMDI budesonide/formotrol 160/4.5 is in group 1Drug
Also called Symbicort
The asthmatic subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI 2 inhalations used in conventional fashion, and have pulmonary function measured over 12 hours who are expected to show bronchodilation.
Symbicort 160/4.5 plus Aerochamber Plus included in group 2Device
Also called Symbicort, Aerochamber plus
Symbicort 160/4.5 2 inhalations will be administered through a valved holding chamber, Aerochamber Plus, Pulmonary functions will be measured over 12 hours in asthmatic subjects who are expected to show bronchodilation.

Study groups in NCT00915538
Study group	Role	What they receive
Group 1 / use of pMDI as approved	Other	The intervention in this group will use inhalation from the pMDI containing budesonide/formoterol pMDI 160/4.5 2 inhalations as approved. (FDA approved product information) without a spacer. The pulmonary function tests (PFTs) will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of budesonide /formoterol; pMDI160/5. Receives: Drug: pMDI budesonide/formotrol 160/4.5 is in group 1; Device: Symbicort 160/4.5 plus Aerochamber Plus included in group 2
Group 2 / pMDI with Aerochamber Plus	Experimental	The intervention in this group will use the pMDI budesonide/formoterol 160/4.5 with a valve holding chamber spacer device, Aerochamber Plus which is the intervention being studied The PFTs will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of Symbicort 160/5. This is the intervention to be studied for comparison to the non-spacer inhalations.. Receives: Drug: pMDI budesonide/formotrol 160/4.5 is in group 1; Device: Symbicort 160/4.5 plus Aerochamber Plus included in group 2

What is being measured

The primary outcome is the main question the study is designed to answer.

The Mean Area Under the Curve (AUC) of Forced Expiratory Volume in One Second (FEV-1) Over 12 Hours, Measured (BL), 5, 10, 15, 60, 120, 240, 480, 720 Minutes. The Unit is Liters, and the AUC is in Liters.
The mean FEV-1 (Forced Expiratory Volume 1 second) for each of the treatments (with and without valved holding chamber) in this crossover design were recorded at BL, 5, 10, 15, 30, 60, 120, 240. 480, 720 minutes (12 hrs) were plotted as a curve and the area under the curve was calculated. The measured results was mean liters/12 hours.
Measured: BL, 5, 10,15,30,60,120,240,480,720 minutes (12 hrs)

Secondary outcomes (1)

FEV-1/FVC
The ratio of the volumes in liters of FEV-1 to Forced vital capacity (FVC). This is reported as percent for each time point., Each time point will be compared.for the two interventions. This expressed as a percentage.
Measured: 0,5,10,15,30,60,120,240,480,720 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Aug 2009

First posted8 Jun 2009 (estimated)
Study startJul 2009
Primary completionAug 2009
Study completionAug 2009

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.
Publications (4)Papers the sponsor has linked to this study.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00915538
Sponsor's protocol ID: WSMR 2008-2
Acronym: WSMR2
Status last verified: Aug 2020
First submitted: 4 Jun 2009
Last updated: 13 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: The results were published in the Journal of Asthma . 2013 Feb :50(1)71-4. Dr. Mansfield was the corresponding author and could be reached by email or phone regarding the study.

Publications

Dolovich MB, Ahrens RC, Hess DR, Anderson P, Dhand R, Rau JL, Smaldone GC, Guyatt G; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest. 2005 Jan;127(1):335-71. doi: 10.1378/chest.127.1.335.
PubMed 15654001
Newman SP. Principles of metered-dose inhaler design. Respir Care. 2005 Sep;50(9):1177-90.
PubMed 16122401
Hess DR. Aerosol delivery devices in the treatment of asthma. Respir Care. 2008 Jun;53(6):699-723; discussion 723-5.
PubMed 18501026
Mansfield LE, Maynes R. A valved holding chamber does not decrease the bronchodilator activity of budesonide-formoterol combination metered dose inhaler. J Asthma. 2013 Feb;50(1):71-4. doi: 10.3109/02770903.2012.745093. Epub 2012 Nov 26.
PubMed 23176189

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of the Bronchodilating Activity of Symbicort Pressure Metered Dose Inhaler (pMDI) 160/4.5 Used in the Conventional Manner and With a Valved Spacer Holding Chamber (Aerochamber Plus)
ClinicalTrials.gov ID: NCT00915538
Acronym / sponsor ID: WSMR2 / WSMR 2008-2
Conditions: Asthma
Keywords: Asthma, Formoterol, Long Acting Beta Adrenergic Bronchodilator, Symbicort, Aerochamber
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Western Sky Medical ResearchUniversity, hospital or other
Collaborators: AstraZeneca
Study start: Jul 2009
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 8 Jun 2009 (estimated)
Results: Posted 13 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1 / use of pMDI as approved	Other	Drug: pMDI budesonide/formotrol 160/4.5 is in group 1, Device: Symbicort 160/4.5 plus Aerochamber Plus included in group 2The intervention in this group will use inhalation from the pMDI containing budesonide/formoterol pMDI 160/4.5 2 inhalations as approved. (FDA approved product information) without a spacer. The pulmonary function tests (PFTs) will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of budesonide /formoterol; pMDI160/5.
Group 2 / pMDI with Aerochamber Plus	Experimental	Drug: pMDI budesonide/formotrol 160/4.5 is in group 1, Device: Symbicort 160/4.5 plus Aerochamber Plus included in group 2The intervention in this group will use the pMDI budesonide/formoterol 160/4.5 with a valve holding chamber spacer device, Aerochamber Plus which is the intervention being studied The PFTs will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of Symbicort 160/5. This is the intervention to be studied for comparison to the non-spacer inhalations..

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Asthma with 15% or more increase in Forced expiratory volume at 1 second (FEV-1) after 180-360 mcg of albuterol pMDI

Key exclusion criteria (1 listed)

Any illness or condition which might place subject at risk in the study;e.g. some cardiovascular disorders Inability to understand and sign informed consent

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
pMDI budesonide/formotrol 160/4.5 is in group 1Also: SymbicortThe asthmatic subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI 2 inhalations used in conventional fashion, and have pulmonary function measured over 12 hours who are expected to show bronchodilation.	Drug	Group 1 / use of pMDI as approved, Group 2 / pMDI with Aerochamber Plus
Symbicort 160/4.5 plus Aerochamber Plus included in group 2Also: Symbicort, Aerochamber plusSymbicort 160/4.5 2 inhalations will be administered through a valved holding chamber, Aerochamber Plus, Pulmonary functions will be measured over 12 hours in asthmatic subjects who are expected to show bronchodilation.	Device	Group 1 / use of pMDI as approved, Group 2 / pMDI with Aerochamber Plus

Primary outcome

The Mean Area Under the Curve (AUC) of Forced Expiratory Volume in One Second (FEV-1) Over 12 Hours, Measured (BL), 5, 10, 15, 60, 120, 240, 480, 720 Minutes. The Unit is Liters, and the AUC is in Liters.
Time frame: BL, 5, 10,15,30,60,120,240,480,720 minutes (12 hrs)
The mean FEV-1 (Forced Expiratory Volume 1 second) for each of the treatments (with and without valved holding chamber) in this crossover design were recorded at BL, 5, 10, 15, 30, 60, 120, 240. 480, 720 minutes (12 hrs) were plotted as a curve and the area under the curve was calculated. The measured results was mean liters/12 hours.

1 secondary outcome

FEV-1/FVC
Time frame: 0,5,10,15,30,60,120,240,480,720 minutes

Results and safety

Results posted to the registry on 13 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Conventional First	8	8
Spacer First	8	8

Primary outcome: The Mean Area Under the Curve (AUC) of Forced Expiratory Volume in One Second (FEV-1) Over 12 Hours, Measured (BL), 5, 10, 15, 60, 120, 240, 480, 720 Minutes. The Unit is Liters, and the AUC is in Liters.

Time frame: BL, 5, 10,15,30,60,120,240,480,720 minutes (12 hrs). Mean (Full Range). Unit: Liters X hours

Measure	Group 1 n = 16	Group 2 n = 16
Value	2.77 (0 to 720)	2.79 (0 to 720)

Group 1 vs Group 2: AUC: 0.0, p = 0.76, t-test, 2 sided
Group 1 vs Group 2: Mean Difference (Net): 0, p >.05, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected during a period of two weeks (the study duration).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Conventional	0 of 16 (0%)	0 of 16 (0%)	Not reported
Spacer	0 of 16 (0%)	0 of 16 (0%)	Not reported

Limitations and caveats (from the sponsor): No subject discontinued subjects were adults experienced in using a pressured metered dose inhaler (pMDI), Spacers or holding chambers are most frequently used by patients with coordination difficulties.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15654001Dolovich MB, Ahrens RC, Hess DR, Anderson P, Dhand R, Rau JL, Smaldone GC, Guyatt G; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest. 2005 Jan;127(1):335-71. doi: 10.1378/chest.127.1.335.
Background: PubMed 16122401Newman SP. Principles of metered-dose inhaler design. Respir Care. 2005 Sep;50(9):1177-90.
Background: PubMed 18501026Hess DR. Aerosol delivery devices in the treatment of asthma. Respir Care. 2008 Jun;53(6):699-723; discussion 723-5.
Derived from this study: PubMed 23176189Mansfield LE, Maynes R. A valved holding chamber does not decrease the bronchodilator activity of budesonide-formoterol combination metered dose inhaler. J Asthma. 2013 Feb;50(1):71-4. doi: 10.3109/02770903.2012.745093. Epub 2012 Nov 26.
Individual participant dataSharing planned: Yes. The results were published in the Journal of Asthma . 2013 Feb :50(1)71-4. Dr. Mansfield was the corresponding author and could be reached by email or phone regarding the study.

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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.

Lyndon E Mansfield, MD principal investigator

Western Sky Medical Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 13 Aug 2020. 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 13 Aug 2020). 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?

The Mean Area Under the Curve (AUC) of Forced Expiratory Volume in One Second (FEV-1) Over 12 Hours, Measured (BL), 5, 10, 15, 60, 120, 240, 480, 720 Minutes. The Unit is Liters, and the AUC is in Liters. (time frame: BL, 5, 10,15,30,60,120,240,480,720 minutes (12 hrs)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00915538, which also lists 4 linked publications.

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 13 Aug 2020.