Trial Outcomes & Findings for Can a Nasal Decongestant Test Predict Treatment Outcomes in Seasonal Allergic Rhinitis? (NCT NCT00618332)

NCT ID: NCT00618332

Last Updated: 2014-02-14

Results Overview

Global Assessment: 3=significantly improved, 2=moderately improved, 1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

at week 2

Results posted on

2014-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	Mometasone Furoate 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks	Placebo 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Can a Nasal Decongestant Test Predict Treatment Outcomes in Seasonal Allergic Rhinitis?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mometasone Furoate n=20 Participants 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks	Placebo n=20 Participants 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks	Total n=40 Participants Total of all reporting groups
Age, Continuous	32.6 years STANDARD_DEVIATION 9.36 • n=5 Participants	35 years STANDARD_DEVIATION 12 • n=7 Participants	33.8 years STANDARD_DEVIATION 10.98 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: at week 2

Population: There were one patient in the Mometasone Furoate group and two patients in the Placebo group with missing values.

Global Assessment: 3=significantly improved, 2=moderately improved, 1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse

Outcome measures

Outcome measures
Measure	Mometasone Furoate n=19 Participants 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks	Placebo n=18 Participants 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks
Global Assessment	1.7 units on a scale Standard Deviation 1.1 • Interval 0.0 to 3.0	1.4 units on a scale Standard Deviation 1.2 • Interval -1.0 to 3.0

SECONDARY outcome

Timeframe: Baseline and 2 weeks

The RQLQ is a disease-specific measure of a patient's quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0-6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores.

Outcome measures

Outcome measures
Measure	Mometasone Furoate n=20 Participants 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks	Placebo n=20 Participants 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks
Changes in RQLQ: Overall	-1.35 units on a scale Standard Deviation 1.09	-1.25 units on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: Baseline and 2 weeks

The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life.

Outcome measures

Outcome measures
Measure	Mometasone Furoate n=20 Participants 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks	Placebo n=20 Participants 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks
Changes in RQLQ: Activity	-1.73 units on a scale Standard Deviation 1.64	-1.55 units on a scale Standard Deviation 1.78

SECONDARY outcome

Timeframe: Baseline and 2 weeks

The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life.

Outcome measures

Outcome measures
Measure	Mometasone Furoate n=20 Participants 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks	Placebo n=20 Participants 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks
Changes in RQLQ: Sleep	-1.42 units on a scale Standard Deviation 1.18	-0.85 units on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: Baseline and 2 weeks

The RQLQ non-nasal/eye range: 0-6. Higher scores indicate a worse quality of life.

Outcome measures

Outcome measures
Measure	Mometasone Furoate n=20 Participants 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks	Placebo n=20 Participants 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks
Changes in RQLQ: Non-Nasal/Eye	-1.11 units on a scale Standard Deviation 1.05	-1.26 units on a scale Standard Deviation 1.22

SECONDARY outcome

Timeframe: Baseline and 2 weeks

The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life.

Outcome measures

Outcome measures
Measure	Mometasone Furoate n=20 Participants 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks	Placebo n=20 Participants 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks
Changes in RQLQ: Practical	-1.37 units on a scale Standard Deviation 1.26	-1.48 units on a scale Standard Deviation 1.54

SECONDARY outcome

Timeframe: Baseline and 2 weeks

The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life.

Outcome measures

Outcome measures
Measure	Mometasone Furoate n=20 Participants 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks	Placebo n=20 Participants 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks
Changes in RQLQ: Nasal	-1.54 units on a scale Standard Deviation 1.47	-1.31 units on a scale Standard Deviation 1.53

SECONDARY outcome

Timeframe: Baseline and 2 weeks

Population: There were one patient in the Mometasone Furoate group with a missing value.

The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life.

Outcome measures

Outcome measures
Measure	Mometasone Furoate n=19 Participants 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks	Placebo n=20 Participants 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks
Changes in RQLQ: Emotional	-1.05 units on a scale Standard Deviation 1.57	-0.94 units on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: Baseline and 2 weeks

The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life.

Outcome measures

Outcome measures
Measure	Mometasone Furoate n=20 Participants 2 weeks of treatment mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks	Placebo n=20 Participants 2 weeks of treatment placebo : 2 puffs in each nostril once a day for 2 weeks
Changes in RQLQ: Eye	-1.36 units on a scale Standard Deviation 1.41	-1.34 units on a scale Standard Deviation 1.32

Adverse Events

Mometasone Furoate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Robert Naclerio

University of Chicago

Phone: 773-702-0080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place