FAMOUS: Fenzian Asthma Multicenter Outcomes Study

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT00784758
• Collaborator: Fenzian Ltd. (Other)
• Enrollment: 81
• Locations: 6
• Arms: 2
• Duration (Months): 27.9
• Patients Per Site: 13.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Device: Fenzian Device; Device: Sham Device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fenzian Device Subjects randomized to this arm will receive treatment with the Fenzian Device	Device: Fenzian Device; Three 20-minute treatments with the Fenzian Device per week for 5 weeks (for a total of 15 treatments)
Sham Comparator: Sham Device Subjects randomized to this arm will receive treatment with the sham device.	Device: Sham Device; 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.)

Outcome Measures

Primary Outcome Measures

1. Change in Asthma Control Questionnaire (ACQ) 7 Score [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.

Secondary Outcome Measures

1. Daily Short-acting Bronchodilator (Albuterol/Salbutamol) Use [2 weeks after completion of treatment (weeks 9-11)]

   Daily short-acting bronchodilator use during the 2 weeks, modeled as a zero-modified negative binomial (usually 2 puffs/day)

2. Short-acting Bronchodilator (Albuterol/Salbutamol) Free Days [2 weeks after completion of treatment (weeks 10 -11)]

   Percent of rescue-free days during a two week period after completing treatment phase

3. Change in Asthma Control Questionnaire 6 Score [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.

4. Change in Spirometry - FEV1 [Baseline to completion of treatment at 9 weeks]

5. Change in Spirometry - Forced Vital Capacity (FVC) [Baseline to completion of treatment at 9 weeks]

6. Change in Spirometry - FEV1/FVC [Baseline to completion of treatment at 9 weeks]

7. Change in Spirometry FEF25-75% [Baseline to completion of treatment at 9 weeks]

   A measure of forced expiratory flow between 25% and 75% of FVC (FEF25-75%)

8. Change in Asthma Control Test Score [Baseline to completion of treatment at 9 weeks]

   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.

9. Change in Mini Asthma Quality of Life Questionnaire (AQLQ) Score (to Evaluate Quality of Life) [Baseline to completion of treatment at 9 weeks]

   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.

10. Change in Sino-Nasal Outcome Test (SNOT-22) - Total Score [Baseline to completion of treatment at 9 weeks]

    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.

11. Change in SNOT-22 Nasal Sub-score [Baseline to completion of treatment at 9 weeks]

    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.

12. Daytime Symptom Score [7 days prior to final assessment visit at week 15]

    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).

13. Change in Transition Dyspnea Index (TDI) - Functional Impairment [Baseline to completion of treatment at 9 weeks]

    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)

14. Change in Transition Dyspnea Index - Magnitude of Task at Visit 3 [Baseline to completion of treatment at 9 weeks]

    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)

15. Change in Transition Dyspnea Index - Magnitude of Effort at Visit 3 [Baseline to completion of treatment at 9 weeks]

    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)

16. Change in Transition Dyspnea Index - Functional Impairment [Baseline to final assessment visit (15 weeks)]

    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)

17. Change in Transition Dyspnea Index - Magnitude of Task [Baseline to final assessment visit (15 weeks)]

    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)

18. Change in Transition Dyspnea Index - Magnitude of Effort [Baseline to final assessment visit (15 weeks)]

    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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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,

• 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

Inclusion Criteria Assessed at Visit 1:

• 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.

Inclusion Criteria Assessed at Visit 2:

• 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

Exclusion Criteria:

• 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.

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095
2	Johns Hopkins University	Baltimore	Maryland	United States	21205
3	Duke University Medical Center	Durham	North Carolina	United States	27710
4	University of Cape Town Lung Institute	Mowbray	Cape Town	South Africa	7700
5	Addenbrookes NHS Trust, Cambridge University	Bottisham	Cambridgeshire	United Kingdom	CB2 OQQ
6	London Chest Hospital	London	England	United Kingdom

Sponsors and Collaborators

• University of California, Los Angeles
• Fenzian Ltd.

Investigators

• Principal Investigator: Christopher B Cooper, M.D., University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eric Kleerup, Clinical Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT00784758
• Other Study ID Numbers: Fenzian
• First Posted: Nov 4, 2008
• Last Update Posted: May 10, 2019
• Last Verified: May 1, 2019

• Keywords provided by Eric Kleerup, Clinical Professor, University of California, Los Angeles: Asthma; Lung Diseases; Respiratory Tract Diseases
• Additional relevant MeSH terms: Asthma

Study Results

Participant Flow

Recruitment Details	Subjects were recruited at six clinical sites using flyers, newspaper, radio and campus advertising, and by contacting participants of prior studies whom agreed to future contacts. The recruitment period lasted from June 2009 to December 17, 2010.
Pre-assignment Detail	Participants who signed consent and passed screening were enrolled into the study and randomized to a treatment arm. One of 42 active treatment participants withdrew consent after being randomized but prior to receiving treatment. He/she did not provide a reason.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	20-minute treatments with the Fenzian Device, 3 times per week for 5 weeks (15 treatments total)	20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Period Title: Overall Study
STARTED	42	39
Began Treatment	41	39
Completed Treatment	40	39
COMPLETED	38	39
NOT COMPLETED	4	0

Baseline Characteristics

Arm/Group Title	Fenzian Device	Sham Device	Total
Arm/Group Description	20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).	Total of all reporting groups
Overall Participants	42	39	81
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	41 97.6%	39 100%	80 98.8%
>=65 years	1 2.4%	0 0%	1 1.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.9 (13.1)	37.2 (13.4)	37.1 (13.2)
Sex: Female, Male (Count of Participants)
Female	21 50%	16 41%	37 45.7%
Male	21 50%	23 59%	44 54.3%
Region of Enrollment (participants) [Number]
United States	10 23.8%	9 23.1%	19 23.5%
South Africa	26 61.9%	22 56.4%	48 59.3%
United Kingdom	6 14.3%	8 20.5%	14 17.3%

Outcome Measures

1. Primary Outcome

Title	Change in Asthma Control Questionnaire (ACQ) 7 Score
Description	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.
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Measure Participants	40	39
Mean (Standard Error) [ACQ7 score]	-0.35 (0.08)	-0.29 (0.08)

2. Secondary Outcome

Title	Daily Short-acting Bronchodilator (Albuterol/Salbutamol) Use
Description	Daily short-acting bronchodilator use during the 2 weeks, modeled as a zero-modified negative binomial (usually 2 puffs/day)
Time Frame	2 weeks after completion of treatment (weeks 9-11)

Outcome Measure Data

Analysis Population Description

All subjects whose short-acting bronchodilator counters were functioning and who completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Measure Participants	28	29
Mean (Standard Deviation) [Puffs/day]	0.83 (1.58)	0.71 (1.23)

3. Secondary Outcome

Title	Short-acting Bronchodilator (Albuterol/Salbutamol) Free Days
Description	Percent of rescue-free days during a two week period after completing treatment phase
Time Frame	2 weeks after completion of treatment (weeks 10 -11)

Outcome Measure Data

Analysis Population Description

All subjects whose short-acting bronchodilator counters were functioning and who completed Visit 3 were included in the analysis

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	28	24
Mean (95% Confidence Interval) [Percent of days]	63	60

4. Secondary Outcome

Title	Change in Asthma Control Questionnaire 6 Score
Description	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.
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	40	39
Mean (Standard Error) [ACQ6 score]	-0.40 (0.09)	-0.29 (0.09)

5. Secondary Outcome

Title	Change in Spirometry - FEV1
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	40	39
Mean (Standard Error) [L]	0.00 (0.04)	0.09 (0.04)

6. Secondary Outcome

Title	Change in Spirometry - Forced Vital Capacity (FVC)
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	40	39
Mean (Standard Error) [L]	-0.07 (0.04)	0.04 (0.04)

7. Secondary Outcome

Title	Change in Spirometry - FEV1/FVC
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	40	39
Mean (Standard Error) [Ratio]	0.81 (1.14)	1.97 (1.13)

8. Secondary Outcome

Title	Change in Spirometry FEF25-75%
Description	A measure of forced expiratory flow between 25% and 75% of FVC (FEF25-75%)
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed treatment (weeks 5-9) were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	40	39
Mean (Standard Error) [L/s]	0.01 (0.07)	0.19 (0.06)

9. Secondary Outcome

Title	Change in Asthma Control Test Score
Description	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.
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	40	39
Mean (Standard Error) [ACT score]	1.49 (0.37)	0.69 (0.37)

10. Secondary Outcome

Title	Change in Mini Asthma Quality of Life Questionnaire (AQLQ) Score (to Evaluate Quality of Life)
Description	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.
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	40	39
Mean (Standard Error) [units on a scale]	0.56 (0.99)	0.31 (0.10)

11. Secondary Outcome

Title	Change in Sino-Nasal Outcome Test (SNOT-22) - Total Score
Description	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.
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	40	39
Mean (Standard Error) [units on a scale]	0.74 (0.31)	0.02 (0.34)

12. Secondary Outcome

Title	Change in SNOT-22 Nasal Sub-score
Description	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.
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	40	39
Mean (Standard Error) [SNOT22 score]	0.26 (0.37)	0.23 (0.40)

13. Secondary Outcome

Title	Daytime Symptom Score
Description	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).
Time Frame	7 days prior to final assessment visit at week 15

Outcome Measure Data

Analysis Population Description

All subjects whose diaries were functioning and who completed diary assessments and completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	13	14
Mean (Standard Deviation) [score on a scale]	0.83 (0.81)	0.65 (0.58)

14. Secondary Outcome

Title	Change in Transition Dyspnea Index (TDI) - Functional Impairment
Description	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)
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	40	39
Mean (Standard Deviation) [units on a scale]	0.87 (1.00)	0.25 (0.69)

15. Secondary Outcome

Title	Change in Transition Dyspnea Index - Magnitude of Task at Visit 3
Description	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)
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	40	39
Mean (Standard Deviation) [units on a scale]	0.84 (0.92)	0.34 (0.76)

16. Secondary Outcome

Title	Change in Transition Dyspnea Index - Magnitude of Effort at Visit 3
Description	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)
Time Frame	Baseline to completion of treatment at 9 weeks

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 3 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	40	39
Mean (Standard Deviation) [units on a scale]	0.87 (0.96)	0.40 (0.95)

17. Secondary Outcome

Title	Change in Transition Dyspnea Index - Functional Impairment
Description	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)
Time Frame	Baseline to final assessment visit (15 weeks)

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 4 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	38	39
Mean (Standard Deviation) [units on a scale]	0.72 (1.10)	0.41 (1.00)

18. Secondary Outcome

Title	Change in Transition Dyspnea Index - Magnitude of Task
Description	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)
Time Frame	Baseline to final assessment visit (15 weeks)

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 4 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	38	39
Mean (Standard Deviation) [units on a scale]	0.62 (1.00)	0.43 (1.10)

19. Secondary Outcome

Title	Change in Transition Dyspnea Index - Magnitude of Effort
Description	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)
Time Frame	Baseline to final assessment visit (15 weeks)

Outcome Measure Data

Analysis Population Description

All subjects who completed Visit 4 were included in the analysis.

Arm/Group Title	Fenzian Device	Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device	Subjects randomized to this arm will receive treatment with the sham device.
Measure Participants	38	39
Mean (Standard Deviation) [units on a scale]	0.69 (1.10)	0.41 (1.10)

Adverse Events

Time Frame	15 weeks for each subject
Adverse Event Reporting Description	All reported adverse events, regardless of relatedness to study
Arm/Group Title	Fenzian Device		Sham Device
Arm/Group Description	Subjects randomized to this arm will receive treatment with the Fenzian Device		Subjects randomized to this arm will receive treatment with the sham device.
All Cause Mortality
	Fenzian Device		Sham Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/39 (0%)
Serious Adverse Events
	Fenzian Device		Sham Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Fenzian Device		Sham Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/40 (70%)		21/39 (53.8%)
Endocrine disorders
Diabetes Mellitus, Type 2	1/40 (2.5%)		0/39 (0%)
Gastrointestinal disorders
Abdominal pain	0/40 (0%)		1/39 (2.6%)
General disorders
Weight loss	1/40 (2.5%)		0/39 (0%)
Infections and infestations
Other infection	4/40 (10%)		1/39 (2.6%)
Candidiasis, Oral	1/40 (2.5%)		1/39 (2.6%)
Injury, poisoning and procedural complications
Injury	1/40 (2.5%)		1/39 (2.6%)
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain	3/40 (7.5%)		3/39 (7.7%)
Nervous system disorders
Central Nervous System Disorders	3/40 (7.5%)		0/39 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation	2/40 (5%)		3/39 (7.7%)
Other dyspnea	1/40 (2.5%)		1/39 (2.6%)
Upper respiratory infections	5/40 (12.5%)		6/39 (15.4%)
Respiratory Tract Infection	1/40 (2.5%)		1/39 (2.6%)
Skin and subcutaneous tissue disorders
Exanthema	2/40 (5%)		1/39 (2.6%)
Sweating	3/40 (7.5%)		1/39 (2.6%)
Edema	0/40 (0%)		1/39 (2.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The University (the PI) must furnish the Sponsor with a copy of any proposed written or oral publication (including manuscripts, abstracts, and oral presentations) at least 30 days prior to submission for publication. The Sponsor can direct the PI to delete their confidential information. The information contained in this results section was provided to the Sponsor 30 days ago and they have not asked for any deletions.