Trial Outcomes & Findings for Fenzian Asthma Multicenter Outcomes Study (NCT NCT00784758)

NCT ID: NCT00784758

Last Updated: 2019-05-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 81 participants
• Primary outcome timeframe: Baseline to completion of treatment at 9 weeks
• Results posted on: 2019-05-10

Participant Flow

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.

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.

Participant milestones

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

Reasons for withdrawal

Measure	Fenzian Device 20-minute treatments with the Fenzian Device, 3 times per week for 5 weeks (15 treatments total)	Sham Device 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Overall Study Withdrawal by Subject	3	0
Overall Study Adverse Event	1	0

Baseline Characteristics

Fenzian Asthma Multicenter Outcomes Study

Baseline characteristics by cohort

Measure	Fenzian Device n=42 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=93 Participants	39 Participants n=4 Participants	80 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Age, Continuous	36.9 years STANDARD_DEVIATION 13.1 • n=93 Participants	37.2 years STANDARD_DEVIATION 13.4 • n=4 Participants	37.1 years STANDARD_DEVIATION 13.2 • n=27 Participants
Sex: Female, Male Female	21 Participants n=93 Participants	16 Participants n=4 Participants	37 Participants n=27 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	23 Participants n=4 Participants	44 Participants n=27 Participants
Region of Enrollment United States	10 participants n=93 Participants	9 participants n=4 Participants	19 participants n=27 Participants
Region of Enrollment South Africa	26 participants n=93 Participants	22 participants n=4 Participants	48 participants n=27 Participants
Region of Enrollment United Kingdom	6 participants n=93 Participants	8 participants n=4 Participants	14 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

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.

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Asthma Control Questionnaire (ACQ) 7 Score	-0.35 ACQ7 score Standard Error 0.08	-0.29 ACQ7 score Standard Error 0.08

SECONDARY outcome

Timeframe: 2 weeks after completion of treatment (weeks 9-11)

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

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

Outcome measures

Measure	Fenzian Device n=28 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=29 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Daily Short-acting Bronchodilator (Albuterol/Salbutamol) Use	0.83 Puffs/day Standard Deviation 1.58	0.71 Puffs/day Standard Deviation 1.23

SECONDARY outcome

Timeframe: 2 weeks after completion of treatment (weeks 10 -11)

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

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

Outcome measures

Measure	Fenzian Device n=28 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=24 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Short-acting Bronchodilator (Albuterol/Salbutamol) Free Days	63 Percent of days Interval 45.0 to 81.0	60 Percent of days Interval 40.0 to 60.0

SECONDARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

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.

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Asthma Control Questionnaire 6 Score	-0.40 ACQ6 score Standard Error 0.09	-0.29 ACQ6 score Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Spirometry - FEV1	0.00 L Standard Error 0.04	0.09 L Standard Error 0.04

SECONDARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Spirometry - Forced Vital Capacity (FVC)	-0.07 L Standard Error 0.04	0.04 L Standard Error 0.04

SECONDARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Spirometry - FEV1/FVC	0.81 Ratio Standard Error 1.14	1.97 Ratio Standard Error 1.13

SECONDARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

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

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Spirometry FEF25-75%	0.01 L/s Standard Error 0.07	0.19 L/s Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

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.

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Asthma Control Test Score	1.49 ACT score Standard Error 0.37	0.69 ACT score Standard Error 0.37

SECONDARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

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.

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Mini Asthma Quality of Life Questionnaire (AQLQ) Score (to Evaluate Quality of Life)	0.56 units on a scale Standard Error 0.99	0.31 units on a scale Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

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.

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Sino-Nasal Outcome Test (SNOT-22) - Total Score	0.74 units on a scale Standard Error 0.31	0.02 units on a scale Standard Error 0.34

SECONDARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

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.

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in SNOT-22 Nasal Sub-score	0.26 SNOT22 score Standard Error 0.37	0.23 SNOT22 score Standard Error 0.40

SECONDARY outcome

Timeframe: 7 days prior to final assessment visit at week 15

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

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).

Outcome measures

Measure	Fenzian Device n=13 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=14 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Daytime Symptom Score	0.83 score on a scale Standard Deviation 0.81	0.65 score on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

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)

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Transition Dyspnea Index (TDI) - Functional Impairment	0.87 units on a scale Standard Deviation 1.00	0.25 units on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

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)

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Transition Dyspnea Index - Magnitude of Task at Visit 3	0.84 units on a scale Standard Deviation 0.92	0.34 units on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: Baseline to completion of treatment at 9 weeks

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

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)

Outcome measures

Measure	Fenzian Device n=40 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Transition Dyspnea Index - Magnitude of Effort at Visit 3	0.87 units on a scale Standard Deviation 0.96	0.40 units on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: Baseline to final assessment visit (15 weeks)

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

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)

Outcome measures

Measure	Fenzian Device n=38 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Transition Dyspnea Index - Functional Impairment	0.72 units on a scale Standard Deviation 1.10	0.41 units on a scale Standard Deviation 1.00

SECONDARY outcome

Timeframe: Baseline to final assessment visit (15 weeks)

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

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)

Outcome measures

Measure	Fenzian Device n=38 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Transition Dyspnea Index - Magnitude of Task	0.62 units on a scale Standard Deviation 1.00	0.43 units on a scale Standard Deviation 1.10

SECONDARY outcome

Timeframe: Baseline to final assessment visit (15 weeks)

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

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)

Outcome measures

Measure	Fenzian Device n=38 Participants 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total).	Sham Device n=39 Participants 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total).
Change in Transition Dyspnea Index - Magnitude of Effort	0.69 units on a scale Standard Deviation 1.10	0.41 units on a scale Standard Deviation 1.10

Adverse Events

Fenzian Device

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Sham Device

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fenzian Device n=40 participants at risk Subjects randomized to this arm will receive treatment with the Fenzian Device	Sham Device n=39 participants at risk Subjects randomized to this arm will receive treatment with the sham device.
Respiratory, thoracic and mediastinal disorders Asthma exacerbation	5.0% 2/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	7.7% 3/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Respiratory, thoracic and mediastinal disorders Other dyspnea	2.5% 1/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	2.6% 1/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Respiratory, thoracic and mediastinal disorders Upper respiratory infections	12.5% 5/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	15.4% 6/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Infections and infestations Other infection	10.0% 4/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	2.6% 1/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Infections and infestations Candidiasis, Oral	2.5% 1/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	2.6% 1/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Skin and subcutaneous tissue disorders Exanthema	5.0% 2/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	2.6% 1/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	7.5% 3/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	7.7% 3/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Injury, poisoning and procedural complications Injury	2.5% 1/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	2.6% 1/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Skin and subcutaneous tissue disorders Sweating	7.5% 3/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	2.6% 1/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Skin and subcutaneous tissue disorders Edema	0.00% 0/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	2.6% 1/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Gastrointestinal disorders Abdominal pain	0.00% 0/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	2.6% 1/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Endocrine disorders Diabetes Mellitus, Type 2	2.5% 1/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	0.00% 0/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
General disorders Weight loss	2.5% 1/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	0.00% 0/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Nervous system disorders Central Nervous System Disorders	7.5% 3/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	0.00% 0/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study
Respiratory, thoracic and mediastinal disorders Respiratory Tract Infection	2.5% 1/40 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study	2.6% 1/39 • 15 weeks for each subject All reported adverse events, regardless of relatedness to study

Additional Information

Dr. Eric Kleerup

University of California, Los Angeles

Phone: 310-794-6593

Email: ekleerup@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER