Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study
Phase: NA
Conditions: Bronchiolitis
Sponsor: Baylor College of Medicine

Cover page 
 
Title: Comparing Nasal Suction Devices in Children with Bronchiolitis: A Pilot Study 
 
NCT#  NCT02219334 
 
Last IRB approval date: 10/11/19 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals  
Protocol Number:    H-33659 
Status:                        Approved 
Initial Submit Date:  1/3/2014 
Approval Period:       11/7/2018 - 11/6/2019
 Section Aa:  Title & PIA1.  Main Title 
    COMPARING NASAL SUCTION DEVICES IN CHILDREN WITH BRONCHIOLITIS: A PILOT STUDY. 
A2.  Principal Investigator 
  
    Name:   
MARY D. GORDON 
Phone:   832-824-3800 
    Id:   
175564 
Fax:   
    Department:   PEDIATRICS: RENAL 
Email:    mdgordon@bcm.tmc.edu 
    Center:   
Mail 
Stn:   
BCM320 
A3.  Administrative Contact 
  
    Name: 
VICTOR MARIO GONZALEZ 
Phone:   832-824-5459 
    Id:   
164416 
Fax:   
    
Email:    vmgonzal@bcm.tmc.edu 
    
Mail Stn:   BCM320 
A3a.  Financial Conflict of Interest 
Does any member of study personnel (Investigator (including investigator’s spouse and/or dependent 
children)) that are involved in the design, conduct, or reporting of the research have a Significant 
Financial Interest (SFI) that would reasonably appear to be affected by the research for which funding is 
sought and/or associated with an entity/business that would reasonably appear to be affected by the 
research? 
        No
 Section Ab:  General Information     
A4.  Co-Investigators 

  
    Name:   
ADERONKE OJO 
Phone:   832-824-5409 
Id:   
050107 
Fax:   
832-825-5424 
Department:   PEDIATRICS: EMERGENCY MEDICINE 
Email:    aojo@bcm.tmc.edu 
Center:   
Mail Stn:   BCM320 
  
    Name:   
SHABANA YUSUF 
Phone:   832-824-5497 
Id:   
148304 
Fax:   
Department:   PEDIATRICS: EMERGENCY MEDICINE 
Email:    syusuf@bcm.tmc.edu 
Center:   
Mail Stn:   BCM320 
  
    Name:   
SARAH MESKILL 
Phone:   832-824-5399 
Id:   
180959 
Fax:   
Department:   PEDIATRICS: EMERGENCY MEDICINE 
Email:    meskill@bcm.tmc.edu 
Center:   
Mail Stn:   BCM320 
  
    Name:   
JOSEPH L. HAGAN 
Phone:   832-826-1380 
Id:   
182225 
Fax:   
Department:   PEDIATRICS: NEWBORN 
Email:    jlhagan@bcm.tmc.edu
Center:   
Mail Stn:   BCM320 
  
    Name:   
ELIZABETH WATSON 
Phone:   832-259-3866 
Id:   
Non-Baylor 
Fax:   
Institution:   TCH 
Email:    elwatson@texaschildrens.org 
Address:   
Texas Childrens Hospital 
A5.  Funding Source: 
    Organization:  FRIDABABY LLC 
A6a.  Institution(s) where work will be performed: 

    TCH: Texas Children's Hospital 
A6b.  Research conducted outside of the United States: 
    
Country:   
Facility/Institution:   
Contact/Investigator:   
Phone Number:   
If documentation of assurances has not been sent to the Office of Research, please explain: 
A7.  Research Category: 
    
A8. Therapeutic Intent 
Does this trial have therapeutic intent? 
    No
 Section B:  Exempt RequestB.  Exempt From IRB Review 
    Not Applicable
 Section C:  Background Information 
    
Bronchiolitis is a viral illness and a common cause for admission to the hospital. Most patients with 
bronchiolitis are managed at home. The indications of hospitalization are poor feeding, respiratory 
distress with and without hypoxia. The hospital is a common destination of patients with 
bronchiolitis. Patients are admitted to the hospital for respiratory monitoring, suctioning and poor 
oral intake. The management of bronchiolitis is mostly supportive which includes frequent feedings, 
nasal suctioning, intravenous fluids and oxygen if necessary. Several studies have looked at barriers 
to discharge from the hospital. The factors identified were hypoxia, frequent deep nasal suctioning, 
parental and physician discomfort, respiratory distress, and poor feeding. In one study, 50% of 
parents of patients with bronchiolitis were reluctant to go home. The role of nasal suctioning has not 
been studied extensively. The AAP practice guidelines on bronchiolitis do not support routine deep 
suctioning of the posterior pharynx or larynx. It does, however support suctioning of nares to provide 
temporary relief of nasal congestion. At our institution, nasal suctioning is widely practiced. 
Bronchiolitis is associated with increased mucus production. Patients with mild bronchiolitis are able 
to be managed by suctioning alone. The patients admitted to the hospital get frequent nasal 
suctioning by a suction device. The rationale behind nasal suctioning is that young infants are nose 
breathers and nasal secretions impair their ability to breathe and feed. Nasal suctioning overcomes 
upper airway obstruction and diminishes work of breathing. However, frequent suctioning can cause 
local trauma, rebound swelling and increase length of stay. Since suctioning causes temporary relief, 
suctioning lapses of more than 4 hours potentially can increase length of stay. The role of the 
suctioning device in the management of patients with bronchiolitis has not been studied. Since the 
suction controlled nasal aspirator was first developed by Benincaso et al. in 1973 several nasal 

aspirators and suction devices have been developed. Suctioning can be done by bulb suction devices, 
nasal aspirators or suction catheters connected to pressure devices.6 The potential complications 
include hemodynamic instability, mucosal trauma, pneumothorax, prolonged coughing during the 
procedure, bleeding and cross infection.6 In Italy, a prospective observational study was conducted 
on a nasal aspirator Narhinel and its safety, efficacy and parental satisfaction were studied. The nasal 
aspirator showed improvement in sleep, feeding and improvement in respiration. There were some 
reported instances of minor nasal bleeds. The purpose of our study is to compare an over the counter 
nasal aspirator by the brand name of NoseFrida to the suction device used in the hospital- the 
NeoSucker. The purpose of our study is to determine the safety, efficacy, length of stay and parental 
satisfaction of the Nosefrida in comparison to suction devices used in the hospital setting in patients 
with bronchiolitis. References: 1. Nagakumar P, Doull L. Current therapy for bronchiolitis. Archive 
Diseases of Childhood 2012; 97:827-830. 2. Crocetti MT, Barone MA, Amin DD, Walker AR. Pediatric 
Observation Status Beds on an Inpatient Unit: An Integrated Care Model. Pediatric Emergency Care 
2004: 20(1); 17-21. 3.Diagnosis and Management of Bronchiolitis. Subcommittee on Diagnosis and 
Management of Bronchiolitis. Pediatrics 2006; 118; 1774.4.Mussman GM, Parker MW, Statile A, 
Sucharew H, Brady PW. Suctioning and Length of Stay in Infants Hospitalized with Bronchiolitis. JAMA 
Pediatrics 2013; E1-E8.5.Benincaso FV and Smith MHD. A suction-controlled nasal aspirator for 
collection of nasopharyngeal secretions. The Journal of Pediatrics Feb 1973; 82(2): 297-299.6.Moore 
T. Suctioning techniques for the removal of respiratory secretions. Nursing Standard Feb 2003; 18(9): 
47-53.7.Casati M, Picca M, Marinello R, Quartarone G. Safety of use, efficacy and degree of parental 
satisfaction with the nasal aspirator Narhinel in the treatment of nasal congestion in babies. Minerva 
Pediatrics Aug 2007; 59(4): 315-25. 8.Wai AKC, Kwok WO, Chan MS, Graham CA and Rainer TH. 
Patients¿ perceptions of nasopharyngeal aspiration in the emergency department of a teaching 
hospital in Hong Kong. Emergency Medicine Journal 2007; 24:35-36. . 9. Hampton, E., & Abramson, E. 
(2017). Less is more: Evidence-based management of bronchiolitis. Pediatric Annals, 46(7), e252-256. 
doi:http://dx.doi.org.ezproxyhost.library.tmc.edu/10.3928/19382359-20170620-02 
 Section D:  Purpose and Objectives 
    
The purpose of our study is to compare the NoseFrida with the neosucker nasal suction device used 
in the hospital setting for patients with bronchiolitis. If this device (Nose Frida) is comparable to the 
neosucker device, patients with bronchiolitis can be managed at home and potentially avoid hospital 
admission. The objectives of this study are to answer the following research questions: 1) Is there a 
difference in the length of stay for patients treated with the NoseFrida compared to the NeoSucker? 
2) What is the level of satisfaction of the parents of patients treated with the NoseFrida? 3) Does the 
proportion of patients readmitted within 48 hours differ for NoseFrida compared to the NeoSucker? 
4) Do complication rates differ for NoseFrida compared to the NeoSucker? 
 Section E:  Protocol Risks/SubjectsE1.  Risk Category 
    Category 1: Research not involving greater than minimum risk. 
E2.  Subjects 
Gender: 

    Both
Age: 
    Infant/Toddler (0-36 mos) 
Ethnicity: 
    All Ethnicities
Primary Language: 
    English, Spanish
Groups to be recruited will include: 
    Patients
Which if any of the following vulnerable populations will be recruited as subjects? 
    Children 
Vulnerable populations require special protections.  How will you obtain informed consent, protect 
subject confidentiality, and prevent undue coercion? 
    
The protection of human subject is important in this study. Patient confidentiality will be protected 
and maintained during the study. No personal identifiers will be used on the database. Confidentiality 
of information will be maintained by using identifier numbers only on study records. Chart review will 
only be done within the facility. The patient identity will not be recorded and the investigators will 
protect the confidentiality of the records. No potential risk or discomfort is anticipated to the 
individual patients as the device being used is a nasal aspirator which is over the counter product 
recommended for suction of babies with nasal congestion. 
E3.  Pregnant woman/fetus 
Will pregnant women and/or fetuses (as described in 45 CFR 46 Subpart B) be enrolled in the research? 
    No
E4.  Neonates 
Will neonates of uncertain viability or nonviable neonates (as described in 45 CFR 46 Subpart B) be 
enrolled in the research? 
    No
E5.  Children 
Will children be enrolled in the research? 
    Yes
 Section F:  Design/ProcedureF1.  Design 

Select one category that most adequately describes your research: 
    c) Pilot
Discuss the research design including but not limited to such issues as: probability of group assignment, 
potential for subject to be randomized to placebo group, use of control subjects, etc. 
    
The study will be performed at TCH Main Campus inpatient units. This study is a pilot study. A sample 
size of 150 has been calculated to provide a rough estimate of how many patients need to be 
enrolled for the study. The target population for this study is patients with bronchiolitis admitted to 
the hospital for poor feeding, respiratory distress, or for frequent nasal suctioning. Patients who 
meet inclusion criteria will be randomized into 2 groups (NoseFrida group and NeoSucker group 
which is the standard of care). The potential subjects may or may not be the clinical patients of the PI 
and co-investigators. The patients may be taken care by other physicians in the hospital setting. Block 
randomization will be used with a block size of four to ensure that a similar number of subjects are 
assigned to each device. The study statistician will generate the randomization sequence before 
study enrollment begins. Sequentially numbered sealed envelopes will contain the device to which 
the patient is randomized. 
Inclusion Criteria: 
    
Patients above the age of 2 months and post-gestational age to 44 weeks and less than or equal to 2 
years with signs and symptoms of bronchiolitis and clinical respiratory score (CRS) of less than or 
equal to 4 admitted to the hospital. The patients will have a principle diagnosis of Bronchiolitis. 
Exclusion Criteria: 
    
Patients to be excluded from the study are as follows: Age less than post-gestational age 44 weeks, 
CRS greater than 4, associated hypoxemia requiring high flow oxygen management, already using 
NoseFrida at home, diagnosis of chronic lung disease, oro-facial abnormalities, or hemodynamically 
significant congenital heart disease. Less than 1 year post-op ASD/VSD repair. 
F2.  Procedure 
    
This study is a pilot study which will be performed on children with bronchiolitis admitted to the 
hospital medicine service. The potential subjects may or may not be the patients of the PI and co-
investigators. Patients will be identified based on the inclusion criteria. Consent will be obtained from 
identified patients. A study packet (consent form, inclusion and exclusion criteria and data collection 
tool) will be then initiated and completed by the Research Coordinator. This study packet will remain 
with the patients chart until disposition, when they are to be collected and stored in a password 
protected computer. Upon enrollment, the study patients will be randomized to nasal suctioning by 
either the NoseFrida or the NeoSucker suction catheter device. The subject¿s participation in this 
research study will continue until discharged or moved to a higher level of care. The PLAN procedure 
in SAS version 9.3 (SAS Institute., Cary, NC) will be used to randomize subjects to one of the two 
devices. Block randomization will be used with a block size of four to ensure that a similar number of 
subjects are assigned to each device. The study statistician will generate the randomization sequence 
before study enrollment begins. Sequentially numbered sealed envelopes will contain the device to 

which the patient is randomized. Only after the patient has been consented and enrolled into the 
study will the envelope be opened to reveal the device to which the patient has been randomized. 
For patients randomized to the NoseFrida, the Research Coordinator will provide a video 
demonstration of NoseFrida use and will give an instructional post card to the parent/guardian. Both 
video and postcard will be available in English or Spanish. Parents will then re-demonstrate 
appropriate use of the device. The NoseFrida has four components, the collection container, an 
interchangeable filter, flexible tubing and a mouth piece. The end of the collection device is placed on 
the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece 
and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning. If at 
any time deep suctioning is necessary the nurse will perform as reflective of our current standard of 
care. If at any time overnight the patient requires nasopharyngeal suctioning and the 
parent/guardian are asleep, the nurse will suction with the NeoSucker (current standard of care). The 
NeoSucker is used for nasopharyngeal suctioning and requires a nurse/respiratory therapist. The 
NeoSucker is connected to the extension tubing leading to the wall suction canister. The NeoSucker is 
invasive, placed inside the child's nostril and secretions are then aspirated. We will review patient 
records following discharge from Texas Children's Hospital in order to determine return visits. Data 
will be collected on a data collection tool. A copy of which is attached to this IRB protocol. Once data 
points are collected, data will be stored in a computer which will be only be accessed by the Research 
Coordinator, PI and the co-investigators. Following completion of the database, statistical analysis 
will be performed. 
 Section G:  Sample Size/Data AnalysisG1.  Sample Size 
How many subjects (or specimens, or charts) will be used in this study? 
    Local: 150              Worldwide: 150
Please indicate why you chose the sample size proposed: 
    
This is a pilot study. A sample size has been calculated based on the average length of stay which is 
variable. One hundred and fifty subjects are expected to be enrolled during the study period which 
would yield 75 subjects randomized to each of the two suction devices. For the 136 patients in fiscal 
year 2016, the mean ± standard deviation length of stay was 1.80 ± 1.29 days. Assuming the same 
standard deviation for the NeoSucker, the table below displays the sample sizes needed to achieve 
80% statistical power to detect (α=0.05) various mean length of stay values in the NoseFrida group. 
G2.  Data Analysis 
Provide a description of your plan for data analysis. State the types of comparisons you plan (e.g. 
comparison of means, comparison of proportions, regressions, analysis of variance). Which is the 
PRIMARY comparison/analysis? How will the analyses proposed relate to the primary purposes of your 
study? 
    
Length of stay will be compared for the two devices using two one-sided t-test and parental 
satisfaction will be compared via the Wilcoxon Rank Sum test. The proportion of patients readmitted 
within 48 hours, the proportion requiring deep suctioning, gender, ethnicity, type of medical 
insurance, prior medication, prior hospitalization for similar problems and the proportion of patients 

with various types of symptoms and complications will be compared between the two devices using 
the exact Chi-square test. Frequency of both superficial and deep suctioning will be compared for the 
two devices using the Wilcoxon Rank Sum test while patient age (in months) will be compared using 
Student’s t test. Finally, multiple linear regression will be used to examine the association between 
these covariates and the length of stay, and the potential interaction of these variables with the type 
of nasal suction device used. All data analysis will be performed using SAS 9.3. A 5% significance level 
will be maintained for all hypothesis tests. 
 Section H:  Potential Risks/DiscomfortsH1.  Potential Risks/Discomforts 
Describe and assess any potential risks/discomforts; (physical, psychological, social, legal, or other) and 
assess the likelihood and seriousness of such risks: 
    
This study carries a small risk of potential compromise of patient confidentiality. All patients will be 
consented prior to enrolling in the study. Once enrolled in the study, patient will be given a unique 
identification (ID) number (coded) and the link between this number and patient's information will 
be kept in a separate file. The access to this file will be limited to the PI and co-PI. This will prevent 
compromise of patient confidentiality. There is minimal risk or discomfort associated with both these 
devices. The NoseFrida does not go into the nostril far enough so it is less likely to cause any kind of 
trauma(bleeding, rebound swelling). This device is already in use as a nasal aspirator available over 
the counter product recommended for suction of babies with nasal congestion. The neosucker 
however fully enters the nare and commonly causes bleeding, rebound swelling and trauma. The 
neosucker is the current standard of care for patients with bronchiolitis admitted to the hospital for 
respiratory distress and poor feeding. Our study seeks to compare the efficacy of this device with the 
hospital-based standard of care. 
H2.  Data and safety monitoring plan 
     Do the study activities impart greater than minimal risk to subjects? 
        No
H3.  Coordination of information among sites for multi-site research 
Is the BCM Principal Investigator acting as the SPONSOR-INVESTIGATOR for this multi-site research? 
        No or Not Applicable 
Is BCM the COORDINATING CENTER for this multi-site research? 
        No or Not Applicable 
 Section I:  Potential Benefits 
Describe potential benefit(s) to be gained by the individual subject as a result of participating in the 
planned work. 

    
Information obtained from the study will likely benefit the population from which the subjects were 
drawn. It is anticipated that the use of this device would increase parental satisfaction and 
involvement in patient care. 
Describe potential benefit(s) to society of the planned work. 
    
Information obtained from the study will likely benefit the population from which the subjects were 
drawn. While NoseFrida can be used by the parents, the NeoSucker can only be used by a healthcare 
professional. We anticipate that the use of a parent-controlled nasal suction device will decrease the 
use of limited healthcare resources for nasal suctioning, it will reduce Emergency Department visits, 
and potentially decrease length of stay in the hospital. 
Do anticipated benefits outweigh potential risks? Discuss the risk-to-benefit ratio. 
    
We anticipate the benefits of the study device to positively impact factors like parental confidence in 
caring for children with bronchiolitis, length of stay, and number of Emergency Department visits. 
The risk of using this device are minimal compared to the potential benefits. 
 Section J:  Consent ProceduresJ1.  Waiver of Consent 
Will any portion of this research require a waiver of consent and authorization? 
    No
 J1a.  Waiver of requirement for written documentation of Consent 
Will this research require a waiver of the requirement for written documentation of informed consent? 
    No
J2.  Consent Procedures 
Who will recruit subjects for this study? 
    PI 
PI's staff
Describe how research population will be identified, recruitment procedures, any waiting period 
between informing the prospective participant and obtaining consent, steps taken to minimize the 
possibility of coercion or undue influence and consent procedures in detail. 
    
Patients will be identified based on the inclusion criteria. Consent will be obtained from identified 
patients. A study packet (consent form, inclusion and exclusion criteria and data collection tool) will 
be then initiated and completed by the Research Coordinator. This study packet will remain with the 
patients chart until disposition, when they are to be collected and stored in a password protected 
computer. Upon enrollment, the study patients will be randomized to nasal suctioning by either the 
NoseFrida or the NeoSucker suction catheter device. The PLAN procedure in SAS version 9.3 (SAS 
Institute., Cary, NC) will be used to randomize subjects to one of the two devices. Block 
randomization will be used with a block size of four to ensure that a similar number of subjects are 
assigned to each device. The study statistician will generate the randomization sequence before 

study enrollment begins. Sequentially numbered sealed envelopes will contain the device to which 
the patient is randomized. Only after the patient has been consented and enrolled into the study will 
the envelope be opened to reveal the device to which the patient has been randomized. For patients 
randomized to the NoseFrida, the Research Coordinator will provide a video demonstration of 
NoseFrida use and give an instructional post card to the parent/guardian. Both video and postcard 
will be available in English or Spanish. Parents will then re-demonstrate appropriate use of the 
device. If at any time deep suctioning is necessary the nurse will perform as reflective of our current 
standard of care. If at any time overnight the patient requires nasopharyngeal suctioning and the 
parent/guardian are asleep, the nurse will suction with the NeoSucker (current standard of care). We 
will review patient records following discharge from Texas Children's Hospital in order to determine 
return visits. Data will be collected on a data collection tool. A copy of which is attached to this IRB 
protocol. Once data points are collected, data will be stored in a computer which will be only be 
accessed by the Research Coordinator, PI and the co-investigators. Following completion of the 
database, statistical analysis will be performed. 
Are foreign language consent forms required for this protocol? 
    Yes
Which of the following ways will you document informed consent in languages other than English? 
    Short-Form consent documents 
J3.  Privacy and Intrusiveness 
Will the research involve observation or intrusion in situations where the subjects would normally have 
an expectation of privacy? 
    No
J4.  Children 
Will children be enrolled in the research? 
    Yes
J5.  Neonates 
Will non-viable neonates or neonates of uncertain viability be involved in research? 
    No
J6.  Consent Capacity - Adults who lack capacity 
Will Adult subjects who lack the capacity to give informed consent be enrolled in the research? 
    No
J7.  Prisoners 
Will Prisoners be enrolled in the research? 

    No
 Section K:  Research Related Health Information and Confidentiality 
Will research data include identifiable subject information? 
    Yes
Information from health records such as diagnoses, progress notes, medications, lab or radiology 
findings, etc. 
    Yes
Specific information concerning alcohol abuse: 
    No
Specific information concerning drug abuse: 
    No
Specific information concerning sickle cell anemia: 
    No
Specific information concerning HIV: 
    No
Specific information concerning psychiatry notes: 
    No
Demographic information (name, D.O.B., age, gender, race, etc.): 
    Yes
Full Social Security #: 
    No
Partial Social Security # (Last four digits): 
    No
Billing or financial records: 
    No
Photographs, videotapes, and/or audiotapes of you: 
    No

Other: 
    No
At what institution will the physical research data be kept? 
    At the Pediatric Emergency Research offices.
How will such physical research data be secured? 
    Locked at all times 
At what institution will the electronic research data be kept? 
    Texas Children's Hospital 
Such electronic research data will be secured via BCM IT Services- provided secured network storage of 
electronic research data (Non-Portable devices only): 
    No
Such electronic research data will be secured via Other: 
    Yes, (describe below): 
Secure servers identified by Institution/owner. 
Will there be anyone besides the PI, the study staff, the IRB and the sponsor, who will have access to 
identifiable research data? 
    No
Please describe the methods of transmission of any research data (including PHI, sensitive, and non-
sensitive data) to sponsors and/or collaborators. 
    De-identified data will be shared through secure e-mail 
  
Will you obtain a Certificate of Confidentiality for this study? 
    No
Please further discuss any potential confidentiality issues related to this study. 
    None
 Section L:  Cost/Payment 
Delineate clinical procedures from research procedures. Will subject's insurance (or subject) be 
responsible for research related costs? If so state for which items subject's insurance (or subject) will be 
responsible (surgery, device, drugs, etc). If appropriate, discuss the availability of financial counseling. 

    
NoseFrida device will be provided by the company free of cost to participants of study. Subjects 
insurance will be responsible for normal standard of care costs (NeoSucker) but will not be 
responsible for the research costs. 
If subjects will be paid (money, gift certificates, coupons, etc.) to participate in this research project, 
please note the total dollar amount (or dollar value amount) and distribution plan (one payment, pro-
rated payment, paid upon completion, etc) of the payment. 
Dollar Amount: 
    0 
Distribution Plan: 
    
 Section M:  Genetics 
How would you classify your genetic study? 
    
Discuss the potential for psychological, social, and/or physical harm subsequent to participation in this 
research. Please discuss, considering the following areas: risks to privacy, confidentiality, insurability, 
employability, immigration status, paternity status, educational opportunities, or social stigma. 
    
Will subjects be offered any type of genetic education or counseling, and if so, who will provide the 
education or counseling and under what conditions will it be provided? If there is the possibility that a 
family's pedigree will be presented or published, please describe how you will protect family member's 
confidentiality? 
    
 Section N:  Sample Collection 
None 
 Section O:  Drug Studies 
Does the research involve the use of ANY drug* or biologic? (*A drug is defined as any substance that is 
used to elicit a pharmacologic or physiologic response whether it is for treatment or diagnostic 
purposes) 
    No
Does the research involve the use of ANY gene transfer agent for human gene transfer research? 
    No
O1.  Current Drugs  

Is this study placebo-controlled? 
    No
Will the research involve a radioactive drug that is not approved by the FDA? 
    No
 Section P:  Device Studies 
     Does this research study involve the use of ANY device? 
        Yes
Device 1:  NoseFrida Section Q:  Consent Form(s) 
Consent to participate in study 
 Section R:  Advertisements 
None