Trial Outcomes & Findings for Clinical Equivalence Study of Mometasone Nasal Spray (NCT NCT01850823)

Last Updated: 2020-08-19

Results Overview

The Total Nasal Symptom Score Scale was used. Patients rated each of the following four symptoms on a scale from 0 to 3 : Nasal Congestion, Runny Nose, Sneezing, and Itchy Nose. Measurements were taken twice daily approximately 12 hours apart. 0= No symptom 1. Mild symptoms (sign/symptom present, minimal awareness, easily tolerated) 2. Moderate symptom (definite awareness of sign/symptom, bothersome but tolerable) 3. Severe symptom (sign/symptom hard to tolerate, causes interference with daily activities and/or sleeping)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

880 participants

Primary outcome timeframe

Twice daily from Baseline to 2 weeks

Results posted on

2020-08-19

Participant Flow

Randomized subjects in active treatment.

Participant milestones

Participant milestones
Measure	Placebo Placebo vehicle nasal spray (no active ingredients) Dose = 4 total actuations in alternating nostrils	NASONEX® Nasal Spray (Schering Corporation) Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)	Mometasone Nasal Spray (Watson Laboratories, Inc) Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
Overall Study STARTED	175	350	355
Overall Study COMPLETED	172	347	345
Overall Study NOT COMPLETED	3	3	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo vehicle nasal spray (no active ingredients) Dose = 4 total actuations in alternating nostrils	NASONEX® Nasal Spray (Schering Corporation) Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)	Mometasone Nasal Spray (Watson Laboratories, Inc) Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
Overall Study Early Visit Window	0	1	4
Overall Study Enrolled in Error	0	1	2
Overall Study Lack of Efficacy	1	0	0
Overall Study Lost to Follow-up	0	0	1
Overall Study Restricted Medication	0	0	2
Overall Study Significant worstening of SAR	0	1	0
Overall Study Withdrawal by Subject	2	0	1

Baseline Characteristics

Clinical Equivalence Study of Mometasone Nasal Spray

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=175 Participants Placebo vehicle nasal spray (no active ingredients) Dose = 4 total actuations in alternating nostrils	NASONEX® Nasal Spray (Schering Corporation) n=350 Participants Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)	Mometasone Nasal Spray (Watson Laboratories, Inc) n=355 Participants Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)	Total n=880 Participants Total of all reporting groups
Age, Continuous	39.31 years STANDARD_DEVIATION 14.45 • n=5 Participants	38.70 years STANDARD_DEVIATION 14.45 • n=7 Participants	38.80 years STANDARD_DEVIATION 14.18 • n=5 Participants	39.00 years STANDARD_DEVIATION 14.36 • n=4 Participants
Sex: Female, Male Female	126 Participants n=5 Participants	243 Participants n=7 Participants	216 Participants n=5 Participants	585 Participants n=4 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	107 Participants n=7 Participants	139 Participants n=5 Participants	295 Participants n=4 Participants
Race/Ethnicity, Customized White	123 Participants n=5 Participants	259 Participants n=7 Participants	276 Participants n=5 Participants	658 Participants n=4 Participants
Race/Ethnicity, Customized Black/African American	45 Participants n=5 Participants	75 Participants n=7 Participants	68 Participants n=5 Participants	188 Participants n=4 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	25 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Tobacco Use Have used tobacco	7 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	34 Participants n=4 Participants
Tobacco Use Have not use tobacco	168 Participants n=5 Participants	336 Participants n=7 Participants	342 Participants n=5 Participants	846 Participants n=4 Participants
Primary Allergen Tree	110 Participants n=5 Participants	234 Participants n=7 Participants	231 Participants n=5 Participants	575 Participants n=4 Participants
Primary Allergen Multi-Allergen	64 Participants n=5 Participants	114 Participants n=7 Participants	119 Participants n=5 Participants	297 Participants n=4 Participants
Primary Allergen Grass	1 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants

PRIMARY outcome

Timeframe: Twice daily from Baseline to 2 weeks

Population: Per Protocol Population

Outcome measures

Outcome measures
Measure	NASONEX® Nasal Spray (Schering Corporation) n=346 Participants Mometasone Nasal spray, 50 mcg per acuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)	Mometasone Nasal Spray (Watson Laboratories, Inc) n=342 Participants Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)	Mometasone Nasal Spray (Watson Laboratories, Inc) Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14.	1.861 score on a scale Standard Deviation 2.186	1.600 score on a scale Standard Deviation 2.223	—

PRIMARY outcome

Timeframe: Twice daily from Baseline to 2 weeks

Population: Intent to treat.

Superiority analysis of Change From Baseline in rTNSS for both active arms compared to placebo arm. The Total Nasal Symptom Score Scale was used. Patients rated each of the following four symptoms on a scale from 0 to 3: Nasal Congestion, Runny Nose, Sneezing, and Itchy Nose twice daily approximately 12 hours apart. 0= No symptom 1. Mild symptoms (sign/symptom present, minimal awareness, easily tolerated) 2. Moderate symptom (definite awareness of sign/symptom, bothersome but tolerable) 3. Severe symptom (sign/symptom hard to tolerate, causes interference with daily activities and/or sleeping)

Outcome measures

Outcome measures
Measure	NASONEX® Nasal Spray (Schering Corporation) n=173 Participants Mometasone Nasal spray, 50 mcg per acuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)	Mometasone Nasal Spray (Watson Laboratories, Inc) n=348 Participants Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)	Mometasone Nasal Spray (Watson Laboratories, Inc) n=354 Participants Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
Superiority of Active Treatment Arms Over Placebo	0.898 score on a scale Standard Deviation 1.762	1.609 score on a scale Standard Deviation 2.225	1.863 score on a scale Standard Deviation 2.191

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

NASONEX® Nasal Spray (Schering Corporation)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Mometasone Nasal Spray (Watson Laboratories, Inc)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Director, PD/CE Studies

Teva Pharmaceuticals Inc., USA

Phone: 1-888-483-8279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=175 participants at risk Placebo vehicle nasal spray (no active ingredients) Dose = 4 total actuations in alternating nostrils	NASONEX® Nasal Spray (Schering Corporation) n=350 participants at risk Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)	Mometasone Nasal Spray (Watson Laboratories, Inc) n=355 participants at risk Mometasone Nasal spray, 50 mcg per actuation Dose = 4 total actuations in alternating nostrils (total dose = 200 mcg)
Cardiac disorders Palpitations	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Ear and labyrinth disorders Ear Pain	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.57% 2/350 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Endocrine disorders Hyperthryroidism	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Eye disorders Conjunctivitis	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Eye disorders Eye Irritation	0.57% 1/175 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Eye disorders Eye Pain	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Eye disorders Ocular Hyperaemia	0.57% 1/175 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Eye disorders Photophobia	0.57% 1/175 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Gastrointestinal disorders Abdominal Discomfort	0.57% 1/175 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Gastrointestinal disorders Diarrhoea	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Gastrointestinal disorders Vomiting	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
General disorders Toothache	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.57% 2/350 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
General disorders Fatigue	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
General disorders Thirst	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
General disorders Xerosis	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Immune system disorders Hypersensitivity	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Immune system disorders Seasonal Allergy	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Infections and infestations Bronchitis	0.57% 1/175 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Infections and infestations Cellulitis	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Infections and infestations Ear Infection	0.57% 1/175 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Infections and infestations Gastroenteritis	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Infections and infestations Gastroenteritis Viral	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Infections and infestations Herpes Simplex	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Infections and infestations Laryngitis	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Infections and infestations Nasopharyngitis	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Infections and infestations Sinusitis	1.1% 2/175 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Infections and infestations Upper Respiratory Tract Infection	0.57% 1/175 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Infections and infestations Viral Upper Respiratory Tract Infection	0.57% 1/175 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Injury, poisoning and procedural complications Excoriation	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Nervous system disorders Aphonia	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Nervous system disorders Dysgeusia	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Nervous system disorders Headache	1.1% 2/175 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.56% 2/355 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).
Nervous system disorders Sinus Headache	1.1% 2/175 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.57% 2/350 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.56% 2/355 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).
Respiratory, thoracic and mediastinal disorders Throat Irritation	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.86% 3/350 • Number of events 3 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Respiratory, thoracic and mediastinal disorders Epistaxis	2.9% 5/175 • Number of events 6 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.57% 2/350 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.57% 2/350 • Number of events 2 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Respiratory, thoracic and mediastinal disorders Pulmonary Congestion	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.28% 1/355 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/175 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.29% 1/350 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).
Skin and subcutaneous tissue disorders Ecchymosis	0.57% 1/175 • Number of events 1 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/350 • AEs were collected from ICF signature until end of study (~1 month in duration).	0.00% 0/355 • AEs were collected from ICF signature until end of study (~1 month in duration).