Nasal Obstruction
Conditions
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.
Interventions
DRUGTriamcinolone Acetonide
2 sprays sprayed to both nostrils daily for 42 days.
DRUGAyr saline nasal mist
110mcg (2 sprays) sprayed to both nostrils daily for 42 days.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 * NOSE score greater than 55 * Nasal septal deviation on exam
Exclusion criteria
* Intranasal steroid use within the last three months * Current systemic steroid use * Prior septal surgery * Individuals who are pregnant or actively breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray) | Pre-spray NOSE score - 6 weeks Post spray NOSE score- 2 weeks washout - Pre spray Pre-spray NOSE score - 6 weeks Post spray NOSE score | Nasal Obstruction Symptom Evaluation (NOSE) scale: A quality of life (QOL) instrument developed to assess nasal obstruction symptoms in patients undergoing septoplasty. It consists of a 5-item questionnaire, scored on a 5-point (0-4) Likert scale. The raw score ranges from 0-20, which is scaled to a score of 0-100 by multiplying the raw score by 5, where '0' represents 'no problem' and, and '100' represent 'worst problem.' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery. | Postoperative time interval (months): 1-2 , 3-5 , 6-9, 9-12, >12. | Nasal Obstruction Symptom Evaluation (NOSE) scale: A quality of life (QOL) instrument developed to assess nasal obstruction symptoms in patients undergoing septoplasty. It consists of a 5-item questionnaire, scored on a 5-point (0-4) Likert scale. The raw score ranges from 0-20, which is scaled to a score of 0-100 by multiplying the raw score by 5, where '0' represents 'no problem' and, and '100' represent 'worst problem.' |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Triamcinolone Acetonide Then Ayr Spray 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.
Triamcinolone Acetonide: 2 sprays sprayed to both nostrils daily for 42 days.
Ayr saline nasal mist: 110mcg (2 sprays) sprayed to both nostrils daily for 42 days. | 22 |
| Ayr Spray Then Triamcinolone Acetonide 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.
Triamcinolone Acetonide: 2 sprays sprayed to both nostrils daily for 42 days.
Ayr saline nasal mist: 110mcg (2 sprays) sprayed to both nostrils daily for 42 days. | 20 |
| Total | 42 |
Baseline characteristics
| Characteristic | Ayr Spray Then Triamcinolone Acetonide | Total | Triamcinolone Acetonide Then Ayr Spray |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 41 Participants | 21 Participants |
| Age, Continuous | 33.7 years STANDARD_DEVIATION 14.4 | 33.0 years STANDARD_DEVIATION 12.2 | 32.5 years STANDARD_DEVIATION 10.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 20 participants | 42 participants | 22 participants |
| Sex: Female, Male Female | 5 Participants | 16 Participants | 11 Participants |
| Sex: Female, Male Male | 15 Participants | 26 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 20 |
| other Total, other adverse events | 0 / 22 | 0 / 20 |
| serious Total, serious adverse events | 0 / 22 | 0 / 20 |
Outcome results
Primary
Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray)
Nasal Obstruction Symptom Evaluation (NOSE) scale: A quality of life (QOL) instrument developed to assess nasal obstruction symptoms in patients undergoing septoplasty. It consists of a 5-item questionnaire, scored on a 5-point (0-4) Likert scale. The raw score ranges from 0-20, which is scaled to a score of 0-100 by multiplying the raw score by 5, where '0' represents 'no problem' and, and '100' represent 'worst problem.'
Time frame: Pre-spray NOSE score - 6 weeks Post spray NOSE score- 2 weeks washout - Pre spray Pre-spray NOSE score - 6 weeks Post spray NOSE score
Population: Patients requiring nasal surgery for nasal breathing complaints, nasal cosmesis or both.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triamcinolone Acetonide Then Ayr Spray | Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray) | Baseline: Pre - spray 1 NOSE score | 69.1 score on a scale | Standard Deviation 20.4 |
| Triamcinolone Acetonide Then Ayr Spray | Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray) | Post - spray 1 / pre- spray 2 NOSE score | 65.2 score on a scale | Standard Deviation 20.7 |
| Triamcinolone Acetonide Then Ayr Spray | Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray) | Post - spray 2 NOSE score | 64.1 score on a scale | Standard Deviation 20.6 |
| Ayr Spray Then Triamcinolone Acetonide | Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray) | Baseline: Pre - spray 1 NOSE score | 68.5 score on a scale | Standard Deviation 18 |
| Ayr Spray Then Triamcinolone Acetonide | Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray) | Post - spray 1 / pre- spray 2 NOSE score | 65.8 score on a scale | Standard Deviation 20.2 |
| Ayr Spray Then Triamcinolone Acetonide | Nasal Obstruction as Measured by Nasal Obstruction Symptom Evaluation (NOSE) Scores Following Therapy With Treatment (Triamcinolone Acetonide) and Placebo (Ayr Saline Spray) | Post - spray 2 NOSE score | 61.5 score on a scale | Standard Deviation 21.8 |
Comparison: 1\) H0: mean change in NOSE score from baseline after in study group 1 = mean change in NOSE score from baseline in study group 2~Power calculation: 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.p-value: 0.795% CI: [-6, 8.9]t-test, 2 sided
Secondary
Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery.
Nasal Obstruction Symptom Evaluation (NOSE) scale: A quality of life (QOL) instrument developed to assess nasal obstruction symptoms in patients undergoing septoplasty. It consists of a 5-item questionnaire, scored on a 5-point (0-4) Likert scale. The raw score ranges from 0-20, which is scaled to a score of 0-100 by multiplying the raw score by 5, where '0' represents 'no problem' and, and '100' represent 'worst problem.'
Time frame: Postoperative time interval (months): 1-2 , 3-5 , 6-9, 9-12, >12.
Population: Pooled analysis of 35 participants who underwent surgery. Paired t-tests were used to assess differences in mean change in NOSE scores at five post-operative time points compared to baseline NOSE scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triamcinolone Acetonide Then Ayr Spray | Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery. | Baseline NOSE score | 70 score on a scale | Standard Deviation 18.9 |
| Triamcinolone Acetonide Then Ayr Spray | Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery. | Postoperative period: 1-2 months | 16.2 score on a scale | Standard Deviation 20.5 |
| Triamcinolone Acetonide Then Ayr Spray | Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery. | Postoperative period:3-5 months | 17.6 score on a scale | Standard Deviation 16.5 |
| Triamcinolone Acetonide Then Ayr Spray | Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery. | Postoperative period:6-9 months | 17.2 score on a scale | Standard Deviation 19.8 |
| Triamcinolone Acetonide Then Ayr Spray | Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery. | Postoperative period: 9-12 months | 22.2 score on a scale | Standard Deviation 24.9 |
| Triamcinolone Acetonide Then Ayr Spray | Nasal Obstruction Symptom Evaluation (NOSE) Score Following Surgery in Subset of Patients Who Elect to Undergo Surgery. | Postoperative period: >12 months | 20 score on a scale | Standard Deviation 18.8 |
Comparison: H0: Mean pre- treatment baseline patient NOSE score = Mean post- treatment baseline patient NOSE score.p-value: <0.001Paired t-test