Trial Outcomes & Findings for The Effectiveness of Nasal Corticosteroids Versus Placebo in Nasal Obstruction in Patients With Nasal Septal Deviation (NCT NCT02877485)

NCT ID: NCT02877485

Last Updated: 2020-08-13

Results Overview

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.'

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 42 participants
• Primary outcome timeframe: 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
• Results posted on: 2020-08-13

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	22	20
Overall Study COMPLETED	22	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Triamcinolone Acetonide Then Ayr Spray n=22 Participants 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.	Ayr Spray Then Triamcinolone Acetonide n=20 Participants 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.	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=22 Participants	0 Participants n=20 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=22 Participants	20 Participants n=20 Participants	41 Participants n=42 Participants
Age, Categorical >=65 years	1 Participants n=22 Participants	0 Participants n=20 Participants	1 Participants n=42 Participants
Age, Continuous	32.5 years STANDARD_DEVIATION 10.1 • n=22 Participants	33.7 years STANDARD_DEVIATION 14.4 • n=20 Participants	33.0 years STANDARD_DEVIATION 12.2 • n=42 Participants
Sex: Female, Male Female	11 Participants n=22 Participants	5 Participants n=20 Participants	16 Participants n=42 Participants
Sex: Female, Male Male	11 Participants n=22 Participants	15 Participants n=20 Participants	26 Participants n=42 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	22 participants n=22 Participants	20 participants n=20 Participants	42 participants n=42 Participants

PRIMARY outcome

Timeframe: 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.

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.'

Outcome measures

Measure	Triamcinolone Acetonide Then Ayr Spray n=22 Participants 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.	Ayr Spray Then Triamcinolone Acetonide n=20 Participants 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.
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	68.5 score on a scale Standard Deviation 18
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	65.8 score on a scale Standard Deviation 20.2
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	61.5 score on a scale Standard Deviation 21.8

SECONDARY outcome

Timeframe: 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.

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.'

Outcome measures

Measure	Triamcinolone Acetonide Then Ayr Spray n=35 Participants 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.	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.
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	—
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	—
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	—
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	—
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	—
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	—

Adverse Events

Triamcinolone Acetonide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ayr Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sam P. Most MD

Stanford Facial Plastic and Reconstructive Surgery

Phone: 650-736-3223

Email: smost@stanford.edu

Results disclosure agreements

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