Trial Outcomes & Findings for Research in Severe Asthma (RISA) Trial (NCT NCT00214539)

NCT ID: NCT00214539

Last Updated: 2021-02-11

Results Overview

Respiratory adverse events (AEs) per subject reported during the Treatment Period, and Post-Treatment Period (Steroid Stable Phase, and Steroid Wean and Reduced Steroid Phase). Results were calculated by dividing the number of respiratory adverse events during each time period by the number of subjects in each group. Statistics were not calculated.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: Baseline, 12 Months
• Results posted on: 2021-02-11

Participant Flow

Participant milestones

Measure	Alair Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.	Control Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
Randomized STARTED	17	17
Randomized COMPLETED	15	17
Randomized NOT COMPLETED	2	0
Treatment Period STARTED	15	17
Treatment Period COMPLETED	15	17
Treatment Period NOT COMPLETED	0	0
Steroid Stable (Post-Tx to 22-Weeks) STARTED	15	17
Steroid Stable (Post-Tx to 22-Weeks) COMPLETED	15	17
Steroid Stable (Post-Tx to 22-Weeks) NOT COMPLETED	0	0
Reduced Steroid (Post-SS to 52-Weeks) STARTED	15	17
Reduced Steroid (Post-SS to 52-Weeks) COMPLETED	15	17
Reduced Steroid (Post-SS to 52-Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Research in Severe Asthma (RISA) Trial

Baseline characteristics by cohort

Measure	Alair n=15 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.	Control n=17 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).	Total n=32 Participants Total of all reporting groups
Age, Continuous	39.13 years STANDARD_DEVIATION 12.97 • n=5 Participants	42.06 years STANDARD_DEVIATION 12.57 • n=7 Participants	40.69 years STANDARD_DEVIATION 12.64 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment United Kingdom	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Brazil	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 Months

Respiratory adverse events (AEs) per subject reported during the Treatment Period, and Post-Treatment Period (Steroid Stable Phase, and Steroid Wean and Reduced Steroid Phase). Results were calculated by dividing the number of respiratory adverse events during each time period by the number of subjects in each group. Statistics were not calculated.

Outcome measures

Measure	Alair n=15 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.	Control n=17 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
Respiratory Adverse Events Per Subject Treatment Period	9.1 Respiratory Adverse Events/Subject	3.4 Respiratory Adverse Events/Subject
Respiratory Adverse Events Per Subject Steroid Stable Phase	2.6 Respiratory Adverse Events/Subject	2.2 Respiratory Adverse Events/Subject
Respiratory Adverse Events Per Subject Steroid Wean and Reduced Steroid Phase	5.5 Respiratory Adverse Events/Subject	5.3 Respiratory Adverse Events/Subject

SECONDARY outcome

Timeframe: Baseline, 12 Months

Percent Change from Baseline at 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visit in dose of inhaled and/or oral corticosteroids.

Outcome measures

Measure	Alair n=15 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.	Control n=17 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
Use of Maintenance Medications (Change From Baseline) Oral Corticosteroids (OCS)	-63.5 Percent Standard Deviation 45.4	-26.2 Percent Standard Deviation 40.7
Use of Maintenance Medications (Change From Baseline) Inhaled Corticosteroids (ICS)	-28.6 Percent Standard Deviation 30.4	-20.0 Percent Standard Deviation 32.9

SECONDARY outcome

Timeframe: Baseline, 12 Months

Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in use of rescue medications. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.

Outcome measures

Measure	Alair n=15 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.	Control n=17 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
Use of Rescue Medications (Change From Baseline) Steroid Stable Phase	-26.56 Puffs/7 Days Standard Deviation 40.05	-1.47 Puffs/7 Days Standard Deviation 11.66
Use of Rescue Medications (Change From Baseline) Steroid Wean and Reduced Steroid Phase	-25.56 Puffs/7 Days Standard Deviation 31.19	-6.07 Puffs/7 Days Standard Deviation 12.43

SECONDARY outcome

Timeframe: Baseline, 12 Months

Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Total Symptom Score. The Total Symptom Score comprises the sum of six asthma symptom measurements recorded in a Daily Diary. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom Score represents better asthma control.

Outcome measures

Measure	Alair n=15 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.	Control n=17 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
Total Symptom Score (Change From Baseline) Steroid Stable Phase	-1.75 Units on a scale Standard Deviation 2.58	-0.89 Units on a scale Standard Deviation 1.84
Total Symptom Score (Change From Baseline) Steroid Wean and Reduced Steroid Phase	-1.37 Units on a scale Standard Deviation 2.61	-1.21 Units on a scale Standard Deviation 1.63

SECONDARY outcome

Timeframe: Baseline, 12 Months

Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in forced expiratory volume in one second (FEV1). FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.

Outcome measures

Measure	Alair n=15 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.	Control n=17 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) Steroid Stable Phase	14.91 Percent Change Standard Deviation 17.40	-0.94 Percent Change Standard Deviation 22.34
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) Steroid Wean and Reduced Steroid Phase	7.97 Percent Change Standard Deviation 19.13	1.89 Percent Change Standard Deviation 15.00

SECONDARY outcome

Timeframe: Baseline, 12 Months

Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months(Steroid Wean and Reduced Steroid Phase) Follow-up Visits in forced expiratory volume in one second (FEV1). FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.

Outcome measures

Measure	Alair n=15 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.	Control n=17 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) Steroid Stable Phase	5.74 Percent Change Standard Deviation 8.56	-0.82 Percent Change Standard Deviation 16.78
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) Steroid Wean and Reduced Steroid Phase	2.76 Percent Change Standard Deviation 11.57	-1.90 Percent Change Standard Deviation 11.97

SECONDARY outcome

Timeframe: Baseline, 12 Months

Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months (Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Asthma Control Questionnaire (ACQ) score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). The ACQ is based on a one-week recall period. A decrease in the ACQ score indicates better asthma control.

Outcome measures

Measure	Alair n=15 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.	Control n=17 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
Asthma Control Questionnaire (ACQ) Score (Change From Baseline) Steroid Stable Phase	-1.04 Units on a scale Standard Deviation 1.03	-0.13 Units on a scale Standard Deviation 1.00
Asthma Control Questionnaire (ACQ) Score (Change From Baseline) Steroid Wean and Reduced Steroid Phase	-0.99 Units on a scale Standard Deviation 0.83	-0.22 Units on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: Baseline, 12 Months

Change from Baseline at 22-Weeks (Steroid Stable Phase) and 12 Months(Steroid Wean and Reduced Steroid Phase) Follow-up Visits in Asthma Quality of Life Questionnaire (AQLQ) score. The AQLQ is a self-administered patient questionnaire that assesses four aspects or domains of daily life for patients with asthma: symptoms, emotional function, activity limitations, and environmental stimuli. The AQLQ is based on a 2-week recall period and consists of 32 questions, each scored from 1 (Worse) to 7 (Better). An increase in the AQLQ score indicates a better quality of life.

Outcome measures

Measure	Alair n=15 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.	Control n=17 Participants Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) Steroid Stable Phase	1.21 Units on a scale Standard Deviation 1.05	0.15 Units on a scale Standard Deviation 0.75
Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) Steroid Wean and Reduced Steroid Phase	1.53 Units on a scale Standard Deviation 0.79	0.42 Units on a scale Standard Deviation 0.82

Adverse Events

Alair (Treatment Period)

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Control (Treatment Period)

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Alair (Steroid Stable Phase)

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Control (Steroid Stable Phase)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Alair (Steroid Wean and Reduced Steroid Phases)

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Control (Steroid Wean and Reduced Steroid Phases)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Alair (Treatment Period) n=15 participants at risk	Control (Treatment Period) n=17 participants at risk	Alair (Steroid Stable Phase) n=15 participants at risk	Control (Steroid Stable Phase) n=17 participants at risk	Alair (Steroid Wean and Reduced Steroid Phases) n=15 participants at risk	Control (Steroid Wean and Reduced Steroid Phases) n=17 participants at risk
Respiratory, thoracic and mediastinal disorders Atelectasis	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Chest Discomfort	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Cough	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 3/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Respiratory, thoracic and mediastinal disorders Dyspnoea/Wheezing	6.7% 1/15	0.00% 0/17	13.3% 2/15	0.00% 0/17	13.3% 2/15	5.9% 1/17
Hepatobiliary disorders Gallbladder Pain	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Nervous system disorders Headache	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Surgical and medical procedures Hernia Repair	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17

Other adverse events

Measure	Alair (Treatment Period) n=15 participants at risk	Control (Treatment Period) n=17 participants at risk	Alair (Steroid Stable Phase) n=15 participants at risk	Control (Steroid Stable Phase) n=17 participants at risk	Alair (Steroid Wean and Reduced Steroid Phases) n=15 participants at risk	Control (Steroid Wean and Reduced Steroid Phases) n=17 participants at risk
Gastrointestinal disorders Abdominal Discomfort	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Gastrointestinal disorders Abdominal Pain	26.7% 4/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	6.7% 1/15	5.9% 1/17
Gastrointestinal disorders Abdominal Pain Lower	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/15	11.8% 2/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	5.9% 1/17
Injury, poisoning and procedural complications Anaesthetic Complication	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Metabolism and nutrition disorders Anorexia	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 1/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	5.9% 1/17
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Injury, poisoning and procedural complications Arthropod Sting	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Surgical and medical procedures Arthroscopic Surgery	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/15	5.9% 1/17	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Atelectasis	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Musculoskeletal and connective tissue disorders Back Pain	6.7% 1/15	5.9% 1/17	13.3% 2/15	17.6% 3/17	6.7% 1/15	11.8% 2/17
Reproductive system and breast disorders Breast Mass	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Breath Sounds Decreased	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Respiratory, thoracic and mediastinal disorders Bronchial Irritation	13.3% 2/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Gastrointestinal disorders Chapped Lips	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Chest Discomfort	26.7% 4/15	5.9% 1/17	6.7% 1/15	11.8% 2/17	13.3% 2/15	35.3% 6/17
Respiratory, thoracic and mediastinal disorders Chest Pain	33.3% 5/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	5.9% 1/17
Musculoskeletal and connective tissue disorders Chest Wall Pain	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Eye disorders Conjunctivitis	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Injury, poisoning and procedural complications Contusion	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	26.7% 4/15	5.9% 1/17
Respiratory, thoracic and mediastinal disorders Cough	73.3% 11/15	35.3% 6/17	13.3% 2/15	23.5% 4/17	40.0% 6/15	23.5% 4/17
Respiratory, thoracic and mediastinal disorders Crackles Lung	6.7% 1/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Infections and infestations Cystitis	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Skin and subcutaneous tissue disorders Dandruff	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Metabolism and nutrition disorders Dehydration	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Psychiatric disorders Depression	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	13.3% 2/15	0.00% 0/17
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Gastrointestinal disorders Diarrhoea	20.0% 3/15	23.5% 4/17	13.3% 2/15	5.9% 1/17	6.7% 1/15	11.8% 2/17
General disorders Difficulty In Walking	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Nervous system disorders Dizziness	26.7% 4/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Nervous system disorders Dysgeusia	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Gastrointestinal disorders Dyspepsia	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Dyspnoea	60.0% 9/15	29.4% 5/17	33.3% 5/15	41.2% 7/17	53.3% 8/15	58.8% 10/17
Respiratory, thoracic and mediastinal disorders Dyspnoea Exacerbated	0.00% 0/15	11.8% 2/17	13.3% 2/15	0.00% 0/17	6.7% 1/15	23.5% 4/17
Infections and infestations Ear Infection	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	5.9% 1/17
Respiratory, thoracic and mediastinal disorders Epistaxis	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	13.3% 2/15	0.00% 0/17
Eye disorders Eye Inflammation	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Eye disorders Eye Pruritis	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17
Injury, poisoning and procedural complications Fall	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
General disorders Fatigue	0.00% 0/15	0.00% 0/17	0.00% 0/15	17.6% 3/17	6.7% 1/15	0.00% 0/17
Hepatobiliary disorders Gallbladder Pain	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Gastrointestinal disorders Gastroesophageal Reflux Disease	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Haemoptysis	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Nervous system disorders Headache	20.0% 3/15	23.5% 4/17	6.7% 1/15	17.6% 3/17	26.7% 4/15	11.8% 2/17
Surgical and medical procedures Hernia Repair	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Infections and infestations Herpes Simplex	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/15	5.9% 1/17	0.00% 0/15	5.9% 1/17	6.7% 1/15	0.00% 0/17
Immune system disorders Hypersensitivity	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	5.9% 1/17
Vascular disorders Hypertension	6.7% 1/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	6.7% 1/15	5.9% 1/17
Vascular disorders Hypotension	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Hypoxia	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Infections and infestations Infected Insect Bite	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Infections and infestations Infection	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Infections and infestations Influenza	13.3% 2/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
General disorders Influenza Like Illness	0.00% 0/15	5.9% 1/17	0.00% 0/15	5.9% 1/17	0.00% 0/15	5.9% 1/17
Infections and infestations Infusion Site Infection	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17	0.00% 0/15	5.9% 1/17
Psychiatric disorders Insomnia	0.00% 0/15	5.9% 1/17	0.00% 0/15	5.9% 1/17	6.7% 1/15	0.00% 0/17
Psychiatric disorders Irritability	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Injury, poisoning and procedural complications Joint Injury	6.7% 1/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Infections and infestations Laryngitis	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Nervous system disorders Lethargy	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	13.3% 2/15	0.00% 0/17
Injury, poisoning and procedural complications Ligament Sprain	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Injury, poisoning and procedural complications Limb Injury	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17	6.7% 1/15	0.00% 0/17
Infections and infestations Localised Infection	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Musculoskeletal and connective tissue disorders Localised Osteoarthritis	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Lower Respiratory Tract Infection	13.3% 2/15	29.4% 5/17	13.3% 2/15	11.8% 2/17	40.0% 6/15	11.8% 2/17
Injury, poisoning and procedural complications Meniscus Lesion	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Musculoskeletal and connective tissue disorders Muscle Cramp	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Surgical and medical procedures Nail Operation	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Nasal Congestion	20.0% 3/15	17.6% 3/17	13.3% 2/15	5.9% 1/17	20.0% 3/15	23.5% 4/17
Infections and infestations Nasopharyngitis	20.0% 3/15	17.6% 3/17	13.3% 2/15	5.9% 1/17	26.7% 4/15	23.5% 4/17
Gastrointestinal disorders Nausea	26.7% 4/15	5.9% 1/17	6.7% 1/15	5.9% 1/17	0.00% 0/15	11.8% 2/17
Nervous system disorders Neuropathic Pain	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Nocturnal Dyspnoea	6.7% 1/15	5.9% 1/17	20.0% 3/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
General disorders Oedema	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
General disorders Oedema Peripheral	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Infections and infestations Oral Candidiasis	13.3% 2/15	5.9% 1/17	20.0% 3/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Infections and infestations Otitis Media	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	5.9% 1/17
Cardiac disorders Palpitations	6.7% 1/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	13.3% 2/15	0.00% 0/17
Gastrointestinal disorders Pancreatic Cyst	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Nervous system disorders Paraesthesia	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	20.0% 3/15	5.9% 1/17	0.00% 0/15	5.9% 1/17	13.3% 2/15	0.00% 0/17
Renal and urinary disorders Pollakiuria	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Injury, poisoning and procedural complications Post Procedural Pain	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Postnasal Drip	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Productive Cough	53.3% 8/15	23.5% 4/17	13.3% 2/15	23.5% 4/17	53.3% 8/15	5.9% 1/17
General disorders Pyrexia	6.7% 1/15	11.8% 2/17	6.7% 1/15	5.9% 1/17	6.7% 1/15	0.00% 0/17
Skin and subcutaneous tissue disorders Rash	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Respiratory Tract Infection	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Rhinitis	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	13.3% 2/15	5.9% 1/17
Nervous system disorders Sinus Headache	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Infections and infestations Sinusitis	0.00% 0/15	5.9% 1/17	0.00% 0/15	5.9% 1/17	0.00% 0/15	5.9% 1/17
Skin and subcutaneous tissue disorders Skin Chapped	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Injury, poisoning and procedural complications Skin Laceration	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Sputum Discoloured	40.0% 6/15	11.8% 2/17	0.00% 0/15	11.8% 2/17	20.0% 3/15	23.5% 4/17
Gastrointestinal disorders Stomach Discomfort	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Infections and infestations Subcutaneous Abscess	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Skin and subcutaneous tissue disorders Swelling Face	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Nervous system disorders Syncope	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
General disorders Thirst	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Endocrine disorders Thyroid Pain	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Infections and infestations Tooth Abscess	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Surgical and medical procedures Tooth Extraction	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Gastrointestinal disorders Tooth Fracture	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Infections and infestations Tooth Infection	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Gastrointestinal disorders Toothache	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Tracheobronchitis	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17
Nervous system disorders Tremor	0.00% 0/15	5.9% 1/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infection	6.7% 1/15	17.6% 3/17	20.0% 3/15	5.9% 1/17	40.0% 6/15	23.5% 4/17
Infections and infestations Urinary Tract Infection	13.3% 2/15	5.9% 1/17	6.7% 1/15	0.00% 0/17	0.00% 0/15	5.9% 1/17
Infections and infestations Vaginal Candidiasis	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Infections and infestations Vaginal Infection	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Gastrointestinal disorders Vomiting	20.0% 3/15	17.6% 3/17	6.7% 1/15	0.00% 0/17	13.3% 2/15	0.00% 0/17
Investigations Weight Increased	6.7% 1/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Wheezing	73.3% 11/15	23.5% 4/17	40.0% 6/15	11.8% 2/17	33.3% 5/15	58.8% 10/17
Infections and infestations Wound Infection	0.00% 0/15	0.00% 0/17	0.00% 0/15	0.00% 0/17	6.7% 1/15	0.00% 0/17

Additional Information

G Mark Grubb, RN, CCRA

Boston Scientific Corporation

Phone: 412-716-0717

Email: Mark.Grubb@bsci.com

Results disclosure agreements

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

Restriction type: LTE60