AsthmaFAMOUSNCT00784758

Fenzian Asthma Multicenter Outcomes Study

A study testing Fenzian Device in people with Asthma, run by University of California, Los Angeles at 6 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 12 to 80 years
Conditions the study is for: Asthma
What is being tested?: Fenzian Device
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: 6 sitesin 3 countries
Study dates: Feb 2009to Jun 2011
Phase: Interventional
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 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Ages 12-80 years. [NOTE: Only the Johns Hopkins site will enroll subjects under 18.]
Clinical history consistent with asthma (GINA 4 definitions) for at least six months
Current symptoms and features of partly-controlled or uncontrolled asthma, according to GINA classification of asthma control
A stable (1 month) treatment regimen consisting of:
as needed short-acting bronchodilators alone,
as needed short-acting bronchodilators in combination with low- or medium-dose inhaled corticosteroids (<= 1000 mcg per day beclomethasone or equivalent,

Show all 19Show fewer

any combination of long acting beta-agonist bronchodilator and low- or medium-dose inhaled corticosteroid (as defined above),as needed short-acting bronchodilators in combination with montelukast or other leukotriene modifier
Willingness to comply with the study protocol and ability to perform the study procedures.
Willingness to attend the study site according to the specified treatment schedule
Pre-bronchodilator forced expiratory volume at one second (FEV1) between 60% predicted and the lower limit of normal.
Pre-bronchodilator [FEV1/forced vital capacity (FVC)] less than the lower limit of normal.
Reversibility of FEV1 of at least 200 ml, 15-20 minutes after 4 puffs of albuterol HFA pressurized metered-dose inhaler pMDI.
Reversibility of FEV1 of at least 200ml, 15-30 minutes after 4 puffs of albuterol HFA pressurized metered-dose inhaler (pMDI) if not confirmed at Visit 1 plus
Using short-acting bronchodilator therapy on two or more occasions in each of the two weeks preceding Visit 2 plus (Ventolin HFA counter decrease of at least 8 puffs)
Partly controlled or uncontrolled of asthma as indicated by one to three, but not four of the following in each of the two weeks preceding Visit 2:
Daytime symptoms more than twice per week
Any limitation of activity
Any nocturnal symptoms or awakening
peak expiratory flow (PEF)<80% of predicted on any day

Who cannot join

Pulmonary disease other than asthma, such as smoking-related chronic obstructive pulmonary disease (COPD), clinically significant bronchiectasis, lung resection, and interstitial lung disease.
Other significant systemic illness which might, in the opinion of the investigator alter the risk or outcome of the study (e.g. cardiovascular arrhythmias or conduction abnormalities, hyperthyroidism, uncontrolled hypertension, cancer)
Tobacco smoking greater than 10 pack-year of cumulative exposure or current smoking within 10 years.
Respiratory tract infection within 6 weeks of the study.
Seasonal allergies causing symptoms within the past 4 weeks. Perennial or out of season allergic rhinitis is acceptable. Nasal corticosteroids and long-acting antihistamines are acceptable.
Any investigational drug or treatment within 30 days.

Show all 20Show fewer

Use of cromolyn, nedocromil, theophylline, tiotropium, or oral albuterol within 1 week prior to Visit 1 of the study.
Current use of omalizumab or within the last 8 weeks.
Subjects on anti-depressant (mono-amine oxidase inhibitors or tricyclic antidepressants) treatment within 8 weeks.
Non-potassium sparing diuretics unless in fixed combination with potassium-sparing diuretics within one week.
Digoxin, within one week, unless levels have been monitored previously while taking albuterol or long-acting beta2-agonist (LABAs).
Presence of an implanted cardiac pacemaker or neurostimulator. A removable transcutaneous nerve stimulator, not used during the treatment sessions is acceptable.
Non-selective beta agonists. (acceptable choices include: bisprolol, betaxolol, atenolol, acebutolol and metoprolol)
Subjects who are pregnant or breast feeding.
Persons employed by or related to those employed by the investigative site (e.g. Pulmonary Division).
Prior Fenzian treatment for any indication
Hypersensitivity or intolerance of albuterol HFA pMDI (Ventolin) or its components. Note: if the subject is using ipratropium bromide for rescue short-acting bronchodilator, they must specifically not have been placed on that treatment due to intolerance of albuterol/salbutamol.
Inability to withhold, before and during each visit (except the initial consent visit), xanthine-containing foods (coffee, tea, cola, chocolate, etc.) and alcohol for 6 hours, and short-acting bronchodilators for 8 hours.
Unwillingness to stop use of non-study supplied albuterol (nebulized, chlorofluorocarbon (CFC) or HFA), other short-acting beta agonists (e.g. epinephrine, levalbuterol, metaproterenol, pirbuterol, terbutaline) and ipratropium during the study (after consent through visit 4).
Inability to coordinate the timing for doses of long-acting beta agonists (withhold period at least 12 hours prior to visit) with Visits 1, 2, 3 or 4

Trial locations and contacts

6 sites in 3 countries.

Country

City, postcode or hospital

6 sites in 3 countries

United States3 sites

Johns Hopkins University
Baltimore, Maryland, 21205
Duke University Medical Center
Durham, North Carolina, 27710
University of California, Los Angeles
Los Angeles, California, 90095

Other trials in United States

United Kingdom2 sites

Addenbrookes NHS Trust, Cambridge University
Bottisham, Cambridgeshire, CB2 OQQ
London Chest Hospital
London, England

Other trials in United Kingdom

South Africa1 site

University of Cape Town Lung Institute
Mowbray, Cape Town, 7700

Other trials in South Africa

About this study

Official title: Effect of Fenzian™ Treatment on Symptoms, Pulmonary Function and Albuterol/Salbutamol Use in Patients With Mild to Moderate Persistent Asthma: A Multicenter, Sham-Controlled Clinical Trial

The purpose of this study is to investigate the effects of Fenzian™ treatment on symptoms (such as shortness of breath), lung function (how well the lungs work), and albuterol/salbutamol (rescue medication) use in people with asthma. This will be done by comparing the effects of Fenzian™ treatment to the effects of a sham treatment, which looks the same as the Fenzian™ device but doesn't do anything.

The Fenzian™ device is an electrical instrument that the investigators hope will help reduce airway inflammation associated with asthma symptoms by stimulating the nerves with very low electrical currents. The study device will be applied directly to the skin on the back, working along the ribs toward the spine, alternating between left and right sides, and on your face.

Conditions: Asthma
Being tested: Fenzian Device, Sham Device
Keywords: Asthma, Lung Diseases, Respiratory Tract Diseases
Medical subject headings: Asthma, Lung Diseases, Respiratory Tract Diseases

What participants receive

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

Fenzian DeviceDevice
Three 20-minute treatments with the Fenzian Device per week for 5 weeks (for a total of 15 treatments)
Sham DeviceDevice
Three 20-minute treatments with the sham device per week for 5 weeks (for a total of 15 treatments) (NOTE: This arm is similar to a placebo arm in a drug trial.)

Study groups in NCT00784758
Study group	Role	What they receive
Fenzian Device	Experimental	Subjects randomized to this arm will receive treatment with the Fenzian Device Receives: Device: Fenzian Device
Sham Device	Sham comparator	Subjects randomized to this arm will receive treatment with the sham device. Receives: Device: Sham Device

What is being measured

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

Change in Asthma Control Questionnaire (ACQ) 7 Score
Asthma Control Questionnaire (QOL Technologies 2004) Elizabeth Juniper, (Eur Respir J 1999; 14:902-7). Range 0-6, 0 is no symptoms, 6 is maximal symptoms. 0.5 is considered a minimally important difference, 0.75 or less is associated with a 85% chance that the subject's asthma is well controlled, 1.50 or greater is associated with a 88% chance that the subject's asthma is not well controlled. The ACQ consists of 6 patient/subject reported questions on symptoms and a question completed by the staff for categorization of the patient/subjects forced expiratory volume in the first second (FEV1) from spirometry.
Measured: Baseline to completion of treatment at 9 weeks

Secondary outcomes (18)

Daily Short-acting Bronchodilator (Albuterol/Salbutamol) Use
Daily short-acting bronchodilator use during the 2 weeks, modeled as a zero-modified negative binomial (usually 2 puffs/day)
Measured: 2 weeks after completion of treatment (weeks 9-11)
Short-acting Bronchodilator (Albuterol/Salbutamol) Free Days
Percent of rescue-free days during a two week period after completing treatment phase
Measured: 2 weeks after completion of treatment (weeks 10 -11)
Change in Asthma Control Questionnaire 6 Score
Asthma Control Questionnaire (QOL Technologies 2004) Elizabeth Juniper, (Eur Respir J 1999; 14:902-7). Range 0-6, 0 is no symptoms, 6 is maximal symptoms. 0.5 is considered a minimally important difference, 0.75 or less is associated with a 85% chance that the subject's asthma is well controlled, 1.50 or greater is associated with a 88% chance that the subject's asthma is not well controlled. The ACQ consists of 6 patient/subject reported questions on symptoms.
Measured: Baseline to completion of treatment at 9 weeks
Change in Spirometry - FEV1
Measured: Baseline to completion of treatment at 9 weeks
Change in Spirometry - Forced Vital Capacity (FVC)
Measured: Baseline to completion of treatment at 9 weeks
Change in Spirometry - FEV1/FVC
Measured: Baseline to completion of treatment at 9 weeks
Change in Spirometry FEF25-75%
A measure of forced expiratory flow between 25% and 75% of FVC (FEF25-75%)
Measured: Baseline to completion of treatment at 9 weeks
Change in Asthma Control Test Score
The Asthma Control Test is a 5-item questionnaire using 1-5 point Likert scales; maximum score 25 = complete control of asthma; minimum score 5 = poor control of asthma.
Measured: Baseline to completion of treatment at 9 weeks
Change in Mini Asthma Quality of Life Questionnaire (AQLQ) Score (to Evaluate Quality of Life)
The mini AQLQ is a questionnaire specifically designed to assess health status in patients with asthma. The mini-AQLQ consists of 15 questions covering symptoms and activities. Each question is scaled from 1 (poorly controlled asthma) to 7(maximally controlled asthma) where 7 reflects a higher quality of life. Total score is the sum of 15 items and may range from 15-105. An increase in the AQLQ score indicates a better quality of life.
Measured: Baseline to completion of treatment at 9 weeks
Change in Sino-Nasal Outcome Test (SNOT-22) - Total Score
The SNOT-22 is a disease-specific quality of life score for rhinosinusitis. SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.
Measured: Baseline to completion of treatment at 9 weeks
Change in SNOT-22 Nasal Sub-score
Sino-nasal outcome test-22 nasal sub-score. The nasal subscore consists of 8 questions, each on a scale of 0 (no problems) to 5 (as bad as it can be). Higher scores indicate worse symptoms of rhinosinusitis.
Measured: Baseline to completion of treatment at 9 weeks
Daytime Symptom Score
Daytime symptoms due to asthma were assessed via the electronic diary (AM2+ Asthma Monitor) each evening for 7 days prior to the study visit at Week 15. Daily scores were derived from five questions relating to 1) frequency of asthma symptoms, 2) impact of asthma symptoms, 3) activity, 4) impact of asthma on activity, and 5) breathlessness. Each question was scored from 0 (best) to 6 (worst), with the average of 5 questions providing a daily score ranging from 0 (best) to 6 (worst). Each participant's symptom score was calculated as the average of 7 daily scores. Thus, the range of possible scores is from 0 (best) to 6 (worst).
Measured: 7 days prior to final assessment visit at week 15
Change in Transition Dyspnea Index (TDI) - Functional Impairment
The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement)
Measured: Baseline to completion of treatment at 9 weeks
Change in Transition Dyspnea Index - Magnitude of Task at Visit 3
The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement)
Measured: Baseline to completion of treatment at 9 weeks
Change in Transition Dyspnea Index - Magnitude of Effort at Visit 3
The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement)
Measured: Baseline to completion of treatment at 9 weeks
Change in Transition Dyspnea Index - Functional Impairment
The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement)
Measured: Baseline to final assessment visit (15 weeks)
Change in Transition Dyspnea Index - Magnitude of Task
The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement)
Measured: Baseline to final assessment visit (15 weeks)
Change in Transition Dyspnea Index - Magnitude of Effort
The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement)
Measured: Baseline to final assessment visit (15 weeks)

Timeline

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

Feb 2009Jun 2011

First posted4 Nov 2008 (estimated)
Study startFeb 2009
Primary completionJun 2011
Study completionJun 2011

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 California, Los AngelesThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00784758
Sponsor's protocol ID: Fenzian
Acronym: FAMOUS
Status last verified: May 2019
First submitted: 3 Nov 2008
Last updated: 10 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Fenzian™ Treatment on Symptoms, Pulmonary Function and Albuterol/Salbutamol Use in Patients With Mild to Moderate Persistent Asthma: A Multicenter, Sham-Controlled Clinical Trial
ClinicalTrials.gov ID: NCT00784758
Acronym / sponsor ID: FAMOUS / Fenzian
Conditions: Asthma
Keywords: Asthma, Lung Diseases, Respiratory Tract Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Collaborators: Fenzian Ltd.
Study start: Feb 2009
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 4 Nov 2008 (estimated)
Results: Posted 10 May 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Fenzian Device	Experimental	Device: Fenzian DeviceSubjects randomized to this arm will receive treatment with the Fenzian Device
Sham Device	Sham comparator	Device: Sham DeviceSubjects randomized to this arm will receive treatment with the sham device.

Who may qualify

Ages: 12 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (19 listed)

Ages 12-80 years. [NOTE: Only the Johns Hopkins site will enroll subjects under 18.]
Clinical history consistent with asthma (GINA 4 definitions) for at least six months
Current symptoms and features of partly-controlled or uncontrolled asthma, according to GINA classification of asthma control
A stable (1 month) treatment regimen consisting of:
Willingness to comply with the study protocol and ability to perform the study procedures.

Key exclusion criteria (20 listed)

Pulmonary disease other than asthma, such as smoking-related chronic obstructive pulmonary disease (COPD), clinically significant bronchiectasis, lung resection, and interstitial lung disease.
Other significant systemic illness which might, in the opinion of the investigator alter the risk or outcome of the study (e.g. cardiovascular arrhythmias or conduction abnormalities, hyperthyroidism, uncontrolled hypertension, cancer)
Tobacco smoking greater than 10 pack-year of cumulative exposure or current smoking within 10 years.
Respiratory tract infection within 6 weeks of the study.
Seasonal allergies causing symptoms within the past 4 weeks. Perennial or out of season allergic rhinitis is acceptable. Nasal corticosteroids and long-acting antihistamines are acceptable.

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
Fenzian DeviceThree 20-minute treatments with the Fenzian Device per week for 5 weeks (for a total of 15 treatments)	Device	Fenzian Device
Sham DeviceThree 20-minute treatments with the sham device per week for 5 weeks (for a total of 15 treatments) (NOTE: This arm is similar to a placebo arm in a drug trial.)	Device	Sham Device

Primary outcome

Change in Asthma Control Questionnaire (ACQ) 7 Score
Time frame: Baseline to completion of treatment at 9 weeks
Asthma Control Questionnaire (QOL Technologies 2004) Elizabeth Juniper, (Eur Respir J 1999; 14:902-7). Range 0-6, 0 is no symptoms, 6 is maximal symptoms. 0.5 is considered a minimally important difference, 0.75 or less is associated with a 85% chance that the subject's asthma is well controlled, 1.50 or greater is associated with a 88% chance that the subject's asthma is not well controlled. The ACQ consists of 6 patient/subject reported questions on symptoms and a question completed by the staff for categorization of the patient/subjects forced expiratory volume in the first second (FEV1) from spirometry.

18 secondary outcomes

Daily Short-acting Bronchodilator (Albuterol/Salbutamol) Use
Time frame: 2 weeks after completion of treatment (weeks 9-11)
Short-acting Bronchodilator (Albuterol/Salbutamol) Free Days
Time frame: 2 weeks after completion of treatment (weeks 10 -11)
Change in Asthma Control Questionnaire 6 Score
Time frame: Baseline to completion of treatment at 9 weeks
Change in Spirometry - FEV1
Time frame: Baseline to completion of treatment at 9 weeks
Change in Spirometry - Forced Vital Capacity (FVC)
Time frame: Baseline to completion of treatment at 9 weeks
Change in Spirometry - FEV1/FVC
Time frame: Baseline to completion of treatment at 9 weeks
Change in Spirometry FEF25-75%
Time frame: Baseline to completion of treatment at 9 weeks
Change in Asthma Control Test Score
Time frame: Baseline to completion of treatment at 9 weeks
Change in Mini Asthma Quality of Life Questionnaire (AQLQ) Score (to Evaluate Quality of Life)
Time frame: Baseline to completion of treatment at 9 weeks
Change in Sino-Nasal Outcome Test (SNOT-22) - Total Score
Time frame: Baseline to completion of treatment at 9 weeks
Change in SNOT-22 Nasal Sub-score
Time frame: Baseline to completion of treatment at 9 weeks
Daytime Symptom Score
Time frame: 7 days prior to final assessment visit at week 15
Change in Transition Dyspnea Index (TDI) - Functional Impairment
Time frame: Baseline to completion of treatment at 9 weeks
Change in Transition Dyspnea Index - Magnitude of Task at Visit 3
Time frame: Baseline to completion of treatment at 9 weeks
Change in Transition Dyspnea Index - Magnitude of Effort at Visit 3
Time frame: Baseline to completion of treatment at 9 weeks
Change in Transition Dyspnea Index - Functional Impairment
Time frame: Baseline to final assessment visit (15 weeks)
Change in Transition Dyspnea Index - Magnitude of Task
Time frame: Baseline to final assessment visit (15 weeks)
Change in Transition Dyspnea Index - Magnitude of Effort
Time frame: Baseline to final assessment visit (15 weeks)

Results and safety

Results posted to the registry on 10 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fenzian Device	42	38
Sham Device	39	39

Primary outcome: Change in Asthma Control Questionnaire (ACQ) 7 Score

Time frame: Baseline to completion of treatment at 9 weeks. Mean (Standard Error). Unit: ACQ7 score

Measure	Fenzian Device n = 40	Sham Device n = 39
Value	-0.35 (0.08)	-0.29 (0.08)

Population analysed: All subjects who completed Visit 3 (5 weeks of treatment) were included in the analysis.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 weeks for each subject. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fenzian Device	0 of 40 (0%)	28 of 40 (70%)	0 of 40
Sham Device	0 of 39 (0%)	21 of 39 (53.8%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Asthma

RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
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Recruiting
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RecruitingPhase 3
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Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease

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.

Christopher B Cooper, M.D. principal investigator

University of California, Los Angeles

6 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fenzian Device in people with Asthma, run by University of California, Los Angeles at 6 sites in 3 countries.

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 19 inclusion and 20 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 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, United Kingdom, South Africa. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2019). 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 in Asthma Control Questionnaire (ACQ) 7 Score (time frame: Baseline to completion of treatment at 9 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 NCT00784758.

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 10 May 2019.