AsthmaPhase 4TitanNCT00702325
Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans
A Phase 4 study testing Budesonide / formoterol fumarate (SYMBICORT) and Budesonide in people with Asthma, run by AstraZeneca at 57 sites in United States.
Trial summary
To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide / formoterol fumarate (SYMBICORT) and Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 57 sitesUnited States
- Study dates
- Jun 2008to Sep 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- African American (self-reported)
- Documented clinical diagnosis of asthma as defined by the American Thoracic Society (ATS) for at least 6 months prior to Visit 2 and be in stable condition.
- FEV1, measured ≥6 hours after the last dose of short-acting β2-agonist and at least 48 hours after LABA, of 45%-85%, inclusive, of predicted normal.
Who cannot join
- Has been hospitalized at least once for an asthma related condition during the 6 months prior to Visit 2, or has required emergency treatment due to an asthma related condition more than once in the 3 months prior to Visit 2.
- Has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or rectal) for any reason within the 30 days prior to Visit 2.
- Has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 3 that, in the Investigator's opinion, will interfere with the subject's lung function and/or ability to perform spirometry
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Research Site
Alpharetta, Georgia
Research Site
Arlington, Texas
Research Site
Atlanta, Georgia
Research Site
Bentonville, Arkansas
Research Site
Blue Bell, Pennsylvania
Research Site
Centennial, Colorado
Research Site
Charleston, South Carolina
Research Site
Chicago, Illinois
Research Site
Colorado Springs, Colorado
Research Site
Dallas, Texas
Research Site
Decatur, Georgia
Research Site
Durham, North Carolina
Research Site
Emporia, Virginia
Research Site
Flint, Michigan
Research Site
Fort Worth, Texas
Research Site
Greenville, North Carolina
Research Site
Hagerstown, Maryland
Research Site
Hot Springs, Arkansas
Research Site
Houston, Texas
Research Site
Huntington Park, California
Research Site
Inverness, Florida
Research Site
Kansas City, Missouri
Research Site
Lanham, Maryland
Research Site
Largo, Maryland
Research Site
Las Vegas, Nevada
Research Site
Lawrenceville, Georgia
Research Site
Lithia Springs, Georgia
Research Site
Little Rock, Arkansas
Research Site
Long Beach, California
Research Site
Los Angeles, California
Research Site
Los Angles, California
Research Site
Lovejoy, Georgia
Research Site
Malvern, Arkansas
Research Site
McKinney, Texas
Research Site
Memphis, Tennessee
Research Site
Miami, Florida
Research Site
Milwaukee, Wisconsin
Research Site
New York, New York
Research Site
North Syracuse, New York
Research Site
Ocala, Florida
Research Site
Orange, California
Research Site
Pell City, Alabama
Research Site
Plano, Texas
Research Site
Portland, Oregon
Research Site
Raleigh, North Carolina
Research Site
Richmond, Virginia
Research Site
Rolling Hills Estates, California
Research Site
San Antonio, Texas
Research Site
Skillman, New Jersey
Research Site
Spartanburg, South Carolina
Research Site
St Louis, Missouri
Research Site
Tallahassee, Florida
Research Site
Tampa, Florida
Research Site
Towson, Maryland
Research Site
Virginia Beach, Virginia
Research Site
Waco, Texas
Research Site
Waterbury, Connecticut
About this study
Official title: A 12-wk, Rand., Double-blind, Double Dummy, Multi-ctr., Phase IV Study Comparing Efficacy and Safety of SYMBICORT® pMDI 160/4.5 ug x 2 Actuations Twice Daily Versus Pulmicort® (Budesonide Inhalation Powder DPI) 180 ug x 2 Inhalations Twice Daily, in Adult and Adolescent African American Subjects With Asthma
To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.
- Conditions
- Asthma
- Being tested
- Budesonide / formoterol fumarate (SYMBICORT), Budesonide
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide / formoterol fumarate (SYMBICORT)Drug
Also called SYMBICORT
160/4.5 μg x 2 actuations twice daily (bid)
BudesonideDrug
Also called PULMICORT
inhalation powder 180 μg x 2 inhalations bid (PULMICORT)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Budesonide / formoterol fumarate (SYMBICORT) |
| 2 | Active comparator | Not described Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period
Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Secondary outcomes (23)
Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period
Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period
Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period
Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period
Mean change of the FEF (25-75%) value at the baseline (Visit 3) compared to average value of the FEF (25-75%) recorded at visits during treatment period (to week 12). The mean change was calculated.
Measured: Baseline to 12 weeks
Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry
Total number of participants with any first predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma medication)
Measured: 12 weeks
Number of Withdrawals Due to a Predefined Asthma Event
Total number of participants who withdrew due to a predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma meds)
Measured: 12 weeks
Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period
Diary assessment of total asthma symptoms score (treatment average) by Inhaled Corticosteroid (ICS) dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period
Diary assessment of nighttime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)
Measured: Baseline to 12 weeks
Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period
Diary assessment of daytime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)
Measured: Baseline to 12 weeks
Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period
Diary assessment of number of nights free from awakenings due to asthma; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period
Diary assessment of total daily puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period
Diary assessment of total nighttime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period
Diary assessment of total daytime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period
Diary assessment of total (percent) days free from rescue medication use for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period
Diary assessment of number (percent) of days free from asthma symptoms by ICS dose at entry; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period
Diary assessment of number (percent) of asthma-control days (defined as days that were free of symptoms and nighttime and daytime rescue medication use); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)
Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at last week of treatment - During the past week, you could feel your medication begin to work right away
Measured: 12 week
Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])
Mean change in overall score at end of treatment for participants age 17 years and older (scores ranged from 1 to 7, with higher scores indicating better quality of life); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
Measured: Baseline to 12 weeks
Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment
There are 5 questions in the survey, and each question has 5 responses (total score for each question can range from 1 to 5). To score the survey, responses to the 5 questions are added to yield a total score that ranges from 5 (poor control of asthma control) to 25 (complete control of asthma). Score of 20 or higher was indicative of well-controlled asthma.
Measured: 12 weeks
Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)
There are 6 questions in the survey, and each question has 5 responses (total score for each question can range from 6 to 13). Responses to the 6 questions were added to yield a total score that ranged from 36 to 78. Scoring is based on a norm-based method. Higher AIS scores indicated more asthma impact and poorer quality of life; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period.
Measured: Baseline to 12 weeks
Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)
Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at last week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.
Measured: 12 week
Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)
Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at first week of treatment - During the past week, you could feel your medication begin to work right away
Measured: 1 week
Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)
Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at first week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionSep 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 (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ubaldo Martin, MD, Study director, AstraZenecaTomas LG Andersson, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702325
- Sponsor's protocol ID
- D589BL00003
- Acronym
- Titan
- Status last verified
- Oct 2012
- First submitted
- 19 Jun 2008
- Last updated
- 9 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.
PubMed 22329608
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-wk, Rand., Double-blind, Double Dummy, Multi-ctr., Phase IV Study Comparing Efficacy and Safety of SYMBICORT® pMDI 160/4.5 ug x 2 Actuations Twice Daily Versus Pulmicort® (Budesonide Inhalation Powder DPI) 180 ug x 2 Inhalations Twice Daily, in Adult and Adolescent African American Subjects With Asthma
- ClinicalTrials.gov ID
- NCT00702325
- Acronym / sponsor ID
- Titan / D589BL00003
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 9 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Budesonide / formoterol fumarate (SYMBICORT) |
| 2 | Active comparator | Drug: Budesonide |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- African American (self-reported)
- Documented clinical diagnosis of asthma as defined by the American Thoracic Society (ATS) for at least 6 months prior to Visit 2 and be in stable condition.
- FEV1, measured ≥6 hours after the last dose of short-acting β2-agonist and at least 48 hours after LABA, of 45%-85%, inclusive, of predicted normal.
Key exclusion criteria (3 listed)
- Has been hospitalized at least once for an asthma related condition during the 6 months prior to Visit 2, or has required emergency treatment due to an asthma related condition more than once in the 3 months prior to Visit 2.
- Has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or rectal) for any reason within the 30 days prior to Visit 2.
- Has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 3 that, in the Investigator's opinion, will interfere with the subject's lung function and/or ability to perform spirometry
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 |
|---|---|---|
| Budesonide / formoterol fumarate (SYMBICORT)Also: SYMBICORT160/4.5 μg x 2 actuations twice daily (bid) | Drug | 1 |
| BudesonideAlso: PULMICORTinhalation powder 180 μg x 2 inhalations bid (PULMICORT) | Drug | 2 |
Primary outcome
Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period
Time frame: Baseline to 12 weeks
Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period
23 secondary outcomes
Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry
Time frame: 12 weeks
Number of Withdrawals Due to a Predefined Asthma Event
Time frame: 12 weeks
Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period
Time frame: Baseline to 12 weeks
Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)
Time frame: 12 week
Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])
Time frame: Baseline to 12 weeks
Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment
Time frame: 12 weeks
Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)
Time frame: Baseline to 12 weeks
Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)
Time frame: 12 week
Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)
Time frame: 1 week
Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22329608Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.
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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.
Ubaldo Martin, MD study director
AstraZeneca
Tomas LG Andersson study director
AstraZeneca
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide / formoterol fumarate (SYMBICORT) and Budesonide in people with Asthma, run by AstraZeneca at 57 sites 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 3 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 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites 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 9 Nov 2012). 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?
Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period (time frame: Baseline to 12 weeks). 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 NCT00702325, which also lists 1 linked publication.
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 9 Nov 2012.