Clinical trial NCT02877485
Conditions: Nasal Obstruction
Sponsor: Stanford University
Start date: 2016-08-01; Completion date: 2019-08-15
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this project is to determine if intranasal corticosteroids have an effect on nasal obstruction in patients with nasal septal deviation.

Detailed description:
Participants were identified at their initial visit to the Stanford Facial Plastic and Reconstructive Surgery Clinic, an academic referral center, in consultation for nasal obstruction. If eligible and interested in participating, patients provided written informed consent prior to randomization.

Eligible participants were patients over the age of 18 years of age with the presence of nasal septal deviation as identified by physical examination, as well as a baseline NOSE score of 35 or greater. Exclusion criteria included a history of nasal or septal surgery, use of intranasal steroids in the three months preceding enrollment, use of systemic steroids in the six months preceding enrollment, and pregnancy or active breastfeeding at the time of enrollment. In order to maximize generalizability of the study, no medications other than systemic and intranasal steroids were used as exclusion criteria.

All study participants received 6 weeks of therapy with an intranasal steroid spray, Nasacort (Chattem Inc), which consists of the steroid triamcinolone acetonide, as well as 6 weeks of placebo with Ayr saline spray (B.F. Ascher). These two study drugs were packaged identically by a local pharmacist and labelled Drug A and Drug B. Nasacort was selected as the intranasal steroid following pharmacist consultation, as this intranasal steroid is less scented than others and therefore was less likely to be distinguishable from the placebo to participants. Participants were instructed to use both drugs as follows: 1 spray per nostril twice a day. Researchers, statistical analysts, and study participants were blinded to the identity of the two drugs until the conclusion of the study. A duration of 6 weeks per drug was selected based on the most commonly observed insurance requirements seen in our practice. Following unblinding, it was determined that Drug A was the placebo, the saline spray, and Drug B was the test drug, the nasal steroid.

Following completion of both study drugs, patients were offered surgical intervention. If interested and medically cleared for surgery, patients underwent surgery. All surgeries were performed by the senior author and included open septorhinoplasty to address septal deviation, with repair of nasal valve stenosis and inferior turbinate reduction performed in some patients as deemed necessary by the senior author.

Arms: arm 1: This study arm will start with 6 weeks of therapy with the intranasal steroid, followed by 6 weeks of therapy with a placebo, with a two week washout period in between treatments. arm 2: This study arm will start with 6 weeks of placebo, followed by 6 weeks of therapy with the intranasal steroid, with a two week washout period in between treatments.
Interventions: intervention 1: Triamcinolone Acetonide intervention 2: Ayr saline nasal mist
Intervention descriptions: intervention 1: 2 sprays sprayed to both nostrils daily for 42 days. intervention 2: 110mcg (2 sprays) sprayed to both nostrils daily for 42 days.

Protocol documents:
Prot_SAP_001.pdf: 
The Effectiveness of Nasal Corticosteroids versus 
Placebo in Nasal Obstruction in Patients with Severe 
Nasal Septal Deviation 
 
 
 
 
 
NCT02877485 
 
 
 
April 13, 2016 
 
 
 
 
 
 
 
 
 
 


Study Protocol  
 
Background:  Nasal septal deviation is a common cause of nasal obstruction, a symptom that 
can have a significant effect on a patient's quality of life. Insurance companies often require 
patients to try a >/=6 weeks treatment course with nasal steroids prior to covering nasal surgery. 
This is true even in cases of physician-documented severe or extreme anatomic nasal obstruction 
that have low likelihood of responding to medical therapy.  
 
Purpose: This study will seek to determine if there is any benefit of intranasal steroids in 
decreasing nasal obstruction in patients with severe or extreme septal deviation compared to 
placebo therapy with intranasal saline spray. 
 
Study Population: Individuals who are over the age of 18 with severe or extreme nasal septal 
deviation. 
Exclusion Criteria: Intranasal steroid use within the last three months; current systemic steroid 
use; prior septal surgery; individuals who are pregnant or actively breastfeeding 
 
Study Design: Randomized, double blind controlled crossover trial 
 
Sample size : To detect a 20% difference in NOSE scores with 80% power and a  2-sided alpha 
level of 0.05 required 20 participants per study group, for a total of 40 participants. 
 
Statistical Analysis: Statistical analyses were performed using IBM SPSS version 26 (IBM 
Corp., Armonk, NY, USA).  
1) Independent t-tests will be used to assess differences in mean NOSE scores when comparing 
the two study groups, p<0.05 deemed statistically significant.  
2) Paired t-tests were used to assess differences in mean NOSE scores after saline use, steroid 
use, and at various post-operative time points compared to the patient’s own baseline NOSE 
score. 
Methods: Please see attached page for flow chart of the study protocol 
 
STUDY DESIGN FLOWCHART: 
  
   
Nasal Obstruction Symptom Evaluation (NOSE) Questionnaire and 
Physical Exam  


 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Group 1:  
Start with 6 weeks 
of Nasacort  
Group 2:  
Start with 6 weeks  
Placebo 
NOSE Questionnaire 
+  2 weeks washout w/ 
no therapy  
  6 weeks of Placebo 
 6 weeks of 
Nasacort  
NOSE Questionnaire 
NOSE Questionnaire 
+  2 weeks washout w/ 
no therapy  
NOSE Questionnaire 
  Option to Undergo Nasal 
Septal Surgery (based on 
participant preference and 
medical clearance for 
surgery) 
If Yes, NOSE Questionnaires 
at 5 postoperative periods. 
This marks the end of the 
study  
If No, final NOSE 
Questionnaire one month 
following completion of 
medial therapy. This marks 
the end of the study    

ICF_000.pdf: 
The Effectiveness of Nasal Corticosteroids versus 
Placebo in Nasal Obstruction in Patients with Severe 
Nasal Septal Deviation 
NCT02877485 
May 24, 2019 


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 1 of 13 
 
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Approval Date:   May 24, 2019  
Expiration Date: April 10, 2020 
Participant ID: 
STANFORD CONSENT FORM     
 
PURPOSE OF RESEARCH 
 
You are invited to participate in a research study of the effect of intranasal 
steroids on nasal obstruction.  We hope to learn whether or not intranasal steroids 
provide a significant benefit in patients with significant nasal septal deviation who 
experience nasal obstruction or congestion, as there is currently a requirement 
from many insurance providers that a trial of nasal steroids must be completed 
before perusing surgery to fix nasal septal deviation.  You were selected as a 
possible participant in this study because you have told us that you experience 
nasal obstruction and you have been found to have a deviated septum.  
 
Currently, standard of care therapy is for patients to undergo treatment with an 
intranasal steroid spray for six weeks prior to consideration for nasal surgery to 
address septal deviation for nasal congestion. In this study, participants will 
receive the standard of care therapy plus an additional six weeks of therapy with a 
placebo nasal spray.  
 
 
If you decide to terminate your participation in this study, you should notify Sam 
P. Most at (650) 736 - 3223.   
 
 This research study is looking for 60 people with nasal obstruction and nasal 
septal deviation.  Stanford University expects to enroll 60 research study 
participants.  
 
VOLUNTARY PARTICIPATION  
 
Your participation in this study is entirely voluntary.  Your decision not to 
participate will not have any negative effect on you or your medical care.  You 
can decide to participate now, but withdraw your consent later and stop being in 
the study without any loss of benefits or medical care to which you are entitled. 
 
DURATION OF STUDY INVOLVEMENT  
 
This research study is expected to take approximately 2 years: this is a 2 year 
study with 14 weeks to 8 months of active participation by each participant 
(depending on whether the participant elects to undergo nasal septal surgery). 
Each patient will receive 6 weeks of therapy with Nasacort (an intranasal steroid) 


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 2 of 13 
 
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Expiration Date: April 10, 2020 
Participant ID: 
and 6 weeks of therapy with placebo therapy. There will be a two week washout 
period between these two therapies, meaning that during this time, patients will 
use no nasal sprays.  
 
There will be follow up for either 1 month after the completion of the nasal 
sprays or at 3 and 6 months after nasal septal surgery, should patients elect to 
undergo surgery.  
 
  
PROCEDURES 
 
Participants will be divided into one of two study groups via random assignment 
(50% chance of being assigned to either group). Both groups will receive 
treatment with an intranasal steroid spray and a placebo treatment for 6 weeks 
each, though in reverse order from one another. This is called a “crossover” 
study.  
 
Both sprays will be taken once a day as follows: one spray to each nostril daily. 
Standard of care therapy (ie what we would recommend you do for nasal 
obstruction even if you were not in this study) is six weeks of therapy with the 
intranasal steroid. As such, this study will only add on treatment with a placebo 
nasal spray for six weeks.  
 
Below if a flowchart that diagrams the basic study design.    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 3 of 13 
 
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Approval Date:   May 24, 2019  
Expiration Date: April 10, 2020 
Participant ID: 
STUDY DESIGN FLOWCHART: 
  
   
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Group 1:  
Start with 6 weeks 
of Nasacort  
Group 2:  
Start with 6 weeks  
Placebo 
NOSE Questionnaire 
+  2 weeks washout w/ no 
therapy  
  6 weeks of 
Placebo 
 6 weeks of 
Nasacort  
NOSE Questionnaire 
NOSE Questionnaire 
+  2 weeks washout w/ no 
therapy  
NOSE Questionnaire 
  Option to Undergo 
Nasal Septal Surgery 
(based on participant 
preference and 
Nasal Obstruction Symptom Evaluation (NOSE) Questionnaire 
and Physical Exam  
If YES, NOSE 
Questionnaires at 3 and 6 
months postoperatively. 
This marks the end of the 
study  
If No, final NOSE 
Questionnaire one month 
following completion of 
medial therapy. This marks 
the end of the study  


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 4 of 13 
 
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Expiration Date: April 10, 2020 
Participant ID: 
PARTICIPANT RESPONSIBILITIES           
 
As a participant, your responsibilities include:   
 
• Follow the instructions of the Protocol Director and study staff. 
• Take the study drug as instructed  
• Keep your study appointments.  If it is necessary to miss an appointment, 
please contact the Protocol Director or research study staff to reschedule 
as soon as you know you will miss the appointment. 
• Tell the Protocol Director or research study staff about any side effects, 
doctor visits, or hospitalizations that you may have. 
• Tell the Protocol Director or research staff if you believe you might be 
pregnant or gotten your partner pregnant. 
• Keep the study drug in a safe place, away from children and for your use 
only. 
• Complete your questionnaires as instructed. 
• Ask questions as you think of them. 
• Tell the Protocol Director or research staff if you change your mind about 
staying in the study. 
• Tell the Protocol Director or research staff if you might be pregnant or 
have gotten your partner pregnant during the course of this study.  
 
 
 
WITHDRAWAL FROM STUDY 
 
If you first agree to participate and then you change your mind, you are free to 
withdraw your consent and discontinue your participation at any time.  Your 
decision will not affect your ability to receive medical care for your disease and 
you will not lose any benefits to which you would otherwise be entitled.  
 
If you decide to withdraw your consent to participate in this study, you should 
notify Sam P. Most at (650) 736 - 3223.  
 
If you withdraw from the study, or the study medication is stopped for any 
reason, you must return all study-related supplies, including any unused study 
drug. There are no anticipated consequences of discontinuing the study drug 
early. If you withdraw from the study, you will be contacted by the protocol 
coordinator and asked a short series of questions and then you will be removed 
from the list of active study participants.  


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 5 of 13 
 
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Approval Date:   May 24, 2019  
Expiration Date: April 10, 2020 
Participant ID: 
 
The Protocol Director may also withdraw you from the study and the study 
medication may be stopped without your consent for one or more of the 
following reasons  
o Failure to follow the instructions of the Protocol Director and 
study staff. 
o The Protocol Director decides that continuing your 
participation could be harmful to you. 
o Pregnancy  
o You need treatment not allowed in the study. 
o The study is cancelled.  
o Other administrative reasons. 
o Unanticipated circumstances. 
 
POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES  
 
There are risks, discomforts, and inconveniences associated with any research 
study.  These deserve careful thought.  You should talk with the Protocol 
Director if you have any questions. 
 
Possible side effects of intranasal steroid sprays include nasal irritation, 
headache, cough, and unpleasant taste during administration. Rare, but more 
serious side effects include nasal septal perforation (development of a hole in 
your nasal septum) and oral candidiasis (or thrush) which is a fungal infection 
that requires topical treatment.  
 
Given that all study participants will receive a placebo for 6 weeks, there is a risk 
that your nasal obstruction will be worse during this period than during that 6 
weeks you are treated with the intranasal steroid. Similarly, during the 2 week 
washout period, there is a risk that your nasal obstruction will worsen as 
compared to when you were on the nasal steroid (if you receive the nasal steroid 
first).  
 
Treatment with Nasocort and/or placebo may involve risks to the subject, which 
are currently unforeseeable.  
 
Should you decide to pursue surgery for your septal deviation, there are 
associated risks with surgery. These will be discussed in detail at a preoperative 
appointment (regardless of if you enroll in this study or not). With any surgery, 
there is a small but non-zero risk of adverse effects to anesthesia. There is also a 


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 6 of 13 
 
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Expiration Date: April 10, 2020 
Participant ID: 
risk of bleeding, infection, damage to surrounding structures (eyes, mouth, face). 
Additionally, there is a risk that surgery will incompletely fix your symptoms of  
nasal congestion.  
 
There may be a discomfort of travel time associated with this study; however, 
administration of study therapies and survey materials will occur during 
otherwise scheduled clinic appointments and therefore this discomfort should be 
minimal.  
 
POTENTIAL BENEFITS                              
 
There is a potential benefit of improved nasal congestion following treatment 
with Nasocort.  
 
We cannot and do not guarantee or promise that you will receive any benefits 
from this study. 
 
ALTERNATIVES 
Alternatives to treatment for nasal obstruction include nasal surgery. However, 
as previously stated, many insurance companies require a trial of intranasal 
steroids prior to authorizing surgery to correct septal deviation and therefore first 
undergoing a trial of intranasal steroid spray is standard.  
 
No standard treatment will be withheld as a result of being enrolled in this study. 
You will still have the option to undergo nasal surgery following completion of 
this study, if you are otherwise medically deemed appropriate for surgery.  
 
 
PARTICIPANT’S RIGHTS 
 
You should not feel obligated to agree to participate.  Your questions should be 
answered clearly and to your satisfaction.  If you decide not to participate, tell 
the Protocol Director.   
 
You will be told of any important new information that is learned during the 
course of this research study, which might affect your condition or your 
willingness to continue participation in this study. 
 
You have the right to refuse to answer particular questions that you are asked 
during this study.  


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 7 of 13 
 
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Expiration Date: April 10, 2020 
Participant ID: 
 
 
ClinicalTrials.gov 
 
    
A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not 
include information that can identify you.  At most, the Web site will include a 
summary of the results.  You can search this Web site at any time. 
  
 
 
 
CONFIDENTIALITY 
 
The results of this research study may be presented at scientific or medical 
meetings or published in scientific journals.  Your identity and/or your personal 
health information will not be disclosed except as authorized by you or as 
required by law.  However, there is always some risk that even de-identified 
information might be re-identified.  
  
Patient information may be provided to Federal and other regulatory agencies as 
required.  The Food and Drug Administration (FDA), for example, may inspect 
research records and learn your identity if this study falls within its jurisdiction. 
 


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 8 of 13 
 
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Expiration Date: April 10, 2020 
Participant ID: 
Authorization To Use Your Health Information 
For Research Purposes  
  
Because information about you and your health is personal and 
private, it generally cannot be used in this research study without 
your written authorization.  If you sign this form, it will provide that 
authorization.  The form is intended to inform you about how your 
health information will be used or disclosed in the study.  Your 
information will only be used in accordance with this authorization 
form and the informed consent form and as required or allowed by 
law.  Please read it carefully before signing it.   
 
What is the purpose of this research study and how will my 
health information be utilized in the study? 
 
The purpose of this study is to determine if there is a benefit to using 
intranasal steroids in the treatment of nasal obstruction/congestion in 
patients with a deviated nasal septum. Your health information, 
including the severity of your nasal septal deviation and nasal 
obstruction will be used to assess if there is an effect of intranasal 
steroids on your symptoms.  
 
Do I have to sign this authorization form? 
You do not have to sign this authorization form.  But if you do not, 
you will not be able to participate in this research study.  
 
Signing the form is not a condition for receiving any medical care 
outside the study. 
 
If I sign, can I revoke it or withdraw from the research later? 
If you decide to participate, you are free to withdraw your 
authorization regarding the use and disclosure of your health 
information (and to discontinue any other participation in the study) 
at any time.  After any revocation, your health information will no 


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 9 of 13 
 
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Expiration Date: April 10, 2020 
Participant ID: 
longer be used or disclosed in the study, except to the extent that 
the law allows us to continue using your information (e.g., necessary 
to maintain integrity of research).  If you wish to revoke your 
authorization for the research use or disclosure of your health 
information in this study, you must write to: Dr. Sam P. Most, 801 
Welch Road, Palo Alto, CA 94305. 
 
What Personal Information Will Be Obtained, Used or 
Disclosed? 
Your health information related to this study, may be used or 
disclosed in connection with this research study, including, but not 
limited to: First as last name, gender, date of birth, medical record 
number, telephone number, and electronic mail address as well as 
NOSE scores, physical exam findings obtained during the course of 
the study, and response to medical therapy and surgery.  
 
 
Who May Use or Disclose the Information? 
The following parties are authorized to use and/or disclose your 
health information in connection with this research study: 
• The Protocol Director, Dr. Sam P. Most 
• The Stanford University Administrative Panel on Human 
Subjects in Medical Research and any other unit of Stanford 
University as necessary 
• Research Staff 
  
 
Who May Receive or Use the Information? 
The parties listed in the preceding paragraph may disclose your 
health information to the following persons and organizations for 
their use in connection with this research study:  
 
• The Office for Human Research Protections in the U.S. 
Department of Health and Human Services 
• Food and Drug Administration 


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 10 of 13 
 
SUSampCons_CA_Privacy rev112415 
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Approval Date:   May 24, 2019  
Expiration Date: April 10, 2020 
Participant ID: 
 
 
 
Your information may be re-disclosed by the recipients described 
above, if they are not required by law to protect the privacy of the 
information. 
 
When will my authorization expire? 
Your authorization for the use and/or disclosure of your health 
information will end on February 28, 2030 or when the research 
project ends, whichever is earlier.  
 
Will access to my medical record be limited during the study? 
To maintain the integrity of this research study, you may not have 
access to any health information developed as part of this study until 
it is completed.  At that point, you would have access to such health 
information if it was used to make a medical or billing decision about 
you (e.g., if included in your official medical record).  
 
 
________________________________             
______________ 
Signature of Adult Participant                                           Date 
 
  
_______________________________ 
Printed Name of Adult Participant  
 


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 11 of 13 
 
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Expiration Date: April 10, 2020 
Participant ID: 
FINANCIAL CONSIDERATIONS 
 
Payment 
You will not be paid to participate in this research study. 
 
 
Costs 
There is no cost to you for participating in this study, other than basic expenses 
like transportation and the personal time it will take to come to all of the study 
visits. 
 
Sponsor 
The Stanford Department of Otolaryngology is providing financial support and/or 
material for this study.  
   
COMPENSATION for Research-Related Injury 
 
 All forms of medical diagnosis and treatment – whether routine or experimental 
– involve some risk of injury.  In spite of all precautions, you might develop 
medical complications from participating in this study.  If such complications 
arise, the Protocol Director and the research study staff will assist you in 
obtaining appropriate medical treatment.  In the event that you have an injury or 
illness that is directly caused by your participation in this study, reimbursement 
for all related costs of care first will be sought from your insurer, managed care 
plan, or other benefits program.  You will be responsible for any associated 
co-payments or deductibles as required by your insurance. 
 
If costs of care related to such an injury are not covered by your insurer, 
managed care plan or other benefits program, you may be responsible for these 
costs.  If you are unable to pay for such costs, the Protocol Director will assist 
you in applying for supplemental benefits and explain how to apply for patient 
financial assistance from the hospital. 
 
You do not waive any liability rights for personal injury by signing this form. 
 
CONTACT INFORMATION  
 
 Questions, Concerns, or Complaints:  If you have any questions, concerns or 
complaints about this research study, its procedures, risks and benefits, or 
alternative courses of treatment, you should ask the Protocol Director, Dr. Sam 
P. Most. You may contact her now or later at (650) 736 - 3223 


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 12 of 13 
 
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Approval Date:   May 24, 2019  
Expiration Date: April 10, 2020 
Participant ID: 
 
 Injury Notification:  If you feel you have been hurt by being a part of this study, 
please contact the Protocol Director, Dr. Sam P. Most. You may contact her now 
or later at (650) 736 - 3223 
 
 Independent Contact:  If you are not satisfied with how this study is being 
conducted, or if you have any concerns, complaints, or general questions about 
the research or your rights as a participant, please contact the Stanford 
Institutional Review Board (IRB) to speak to someone independent of the 
research team at (650)-723-5244 or toll free at 1-866-680-2906.  You can also 
write to the Stanford IRB, Stanford University, 1705 El Camino Real, Palo Alto, 
CA 94306. 
 
EXPERIMENTAL SUBJECT’S BILL OF RIGHTS 
 
As a research participant you have the following rights.  These rights include but 
are not limited to the participant’s right to: 
• 
be informed of the nature and purpose of the experiment;  
• 
be given an explanation of the procedures to be followed in the medical 
experiment, and any drug or device to be utilized;  
• 
be given a description of any attendant discomforts and risks reasonably 
to be expected;  
• 
be given an explanation of any benefits to the subject reasonably to be 
expected, if applicable;  
• 
be given a disclosure of any appropriate alternatives, drugs or devices 
that might be advantageous to the subject, their relative risks and 
benefits; 
• 
be informed of the avenues of medical treatment, if any available to the 
subject after the experiment if complications should arise;  
• 
be given an opportunity to ask questions concerning the experiment or 
the procedures involved;  
• 
be instructed that consent to participate in the medical experiment may 
be withdrawn at any time and the subject may discontinue participation 
without prejudice;  
• 
be given a copy of the signed and dated consent form; and  
• 
be given the opportunity to decide to consent or not to consent to a 
medical experiment without the intervention of any element of force, 
fraud, deceit, duress, coercion or undue influence on the subject's 
decision. 
 


 
 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Sam P. Most M.D. 
Protocol Title:   The Effectiveness of Nasal Corticosteroids versus Placebo in Nasal Obstruction in Patients with 
Severe Nasal Septal Deviation 
 
 
Page 13 of 13 
 
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Expiration Date: April 10, 2020 
Participant ID: 
 
  
 May we contact you about future studies that may be of interest to you?    
____ Yes  ____ No 
 
Signing your name means you agree to be in this study and that you will receive 
a copy of this signed and dated consent form.  
 
 
_____________________________________                ____________ 
Signature of Adult Participant 
 
 
 
   
   Date 
 
 
  
_______________________________ 
Printed Name of Adult Participant