NCT00070707 is a Phase 4 clinical trial of Mometasone in Rhinitis, Allergic, Seasonal, sponsored by Organon and Co.

Who is sponsoring NCT00070707?

NCT00070707 is sponsored by Organon and Co.

What drugs are being tested in NCT00070707?

Interventions in NCT00070707: Mometasone, Placebo, Albuterol/Salbutamol.

What condition does NCT00070707 study?

NCT00070707 studies Rhinitis, Allergic, Seasonal, Asthma.

Is NCT00070707 still recruiting?

NCT00070707 is currently completed. Last updated 5 September 2024.

Are results published for NCT00070707?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-09-05 · How we verify

NCT00070707

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280)

Completed Phase 4 Results posted Last updated 5 September 2024

What this trial tests

Phase 4 trial testing Mometasone in Rhinitis, Allergic, Seasonal in 188 participants. Completed in 26 November 2003.

Timeline

3 April 2003

Primary endpoint
26 November 2003

26 November 2003

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	188
Start date	3 April 2003
Primary completion	26 November 2003
Estimated completion	26 November 2003

Drugs / interventions tested

Mometasone — full drug profile →
Placebo
Albuterol/Salbutamol — full drug profile →

Conditions studied

Rhinitis, Allergic, Seasonal — all drugs for Rhinitis, Allergic, Seasonal →
Asthma — all drugs for Asthma →

Sponsor

Organon and Co — full company profile →

Who can join

Adults 15 to 75, any sex, with Rhinitis, Allergic, Seasonal or Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) Primary · Baseline up to Week 4

Each morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her asthma symptoms. The TASS was the sum of severity scores for 4 asthma symptoms: cough, wheeze, difficulty of breathing, and chest tightness. The severity of each asthma symptom was rated on a 4-point scale (0=no symptom; 3=severe); minimum TASS=0; maximum TASS=12. A decrease in TASS indicated an improvement in asthma symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculate

Baseline (AM)

Group	Value	95% CI
Mometasone	6.5	± 0.22
Placebo	5.9	± 0.26

Change at Week 1 (AM)

Group	Value	95% CI
Mometasone	-0.9	± 0.20
Placebo	-1.4	± 0.23

Change at Week 2 (AM)

Group	Value	95% CI
Mometasone	-1.5	± 0.26
Placebo	-1.5	± 0.30

Change at Week 3 (AM)

Group	Value	95% CI
Mometasone	-2.4	± 0.26
Placebo	-2.1	± 0.29

Change at Week 4 (AM)

Group	Value	95% CI
Mometasone	-2.5	± 0.27
Placebo	-2.6	± 0.31

Change at Final Week (AM)

Group	Value	95% CI
Mometasone	-2.2	± 0.25
Placebo	-2.2	± 0.29

Baseline (PM)

Group	Value	95% CI
Mometasone	6.6	± 0.22
Placebo	6.0	± 0.26

Change at Week 1 (PM)

Group	Value	95% CI
Mometasone	-1.4	± 0.19
Placebo	-1.7	± 0.22

Change From Baseline in AM and PM Cough Symptom Score Secondary · Baseline up to Week 4

Cough is an asthma symptom assessed by participants who used diary cards to record morning and evening cough (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her coughing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Cough was rated on a 4-point scale (0=no symptoms \[best score\] to 3=symptoms were hard to tolerate and interfered with daily life activity \[worst score\]). Reduction in score indicated an improvement in cough symptoms. The Final Week was the

Baseline (AM)

Group	Value	95% CI
Mometasone	1.7	± 0.07
Placebo	1.5	± 0.08

Change at Week 1 (AM)

Group	Value	95% CI
Mometasone	-0.3	± 0.05
Placebo	-0.3	± 0.06

Change at Week 2 (AM)

Group	Value	95% CI
Mometasone	-0.4	± 0.07
Placebo	-0.4	± 0.08

Change at Week 3 (AM)

Group	Value	95% CI
Mometasone	-0.7	± 0.08
Placebo	-0.4	± 0.09

Change at Week 4 (AM)

Group	Value	95% CI
Mometasone	-0.7	± 0.08
Placebo	-0.5	± 0.10

Change at Final Week (AM)

Group	Value	95% CI
Mometasone	-0.6	± 0.08
Placebo	-0.5	± 0.09

Baseline (PM)

Group	Value	95% CI
Mometasone	1.7	± 0.07
Placebo	1.5	± 0.08

Change at Week 1 (PM)

Group	Value	95% CI
Mometasone	-0.4	± 0.06
Placebo	-0.4	± 0.07

Change From Baseline in AM and PM Wheeze Symptom Score Secondary · Baseline up to Week 4

Wheezing is a symptom of asthma. The wheezing assessment was based on participant diary data only. Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her wheezing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Wheeze severity was rated on a 4-point scale (0=no wheezing \[best score\] to 3=wheezing was hard to tolerate and interfered with daily life activity \[worst score\]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication,

Baseline (AM)

Group	Value	95% CI
Mometasone	1.5	± 0.07
Placebo	1.3	± 0.09

Change at Week 1 (AM)

Group	Value	95% CI
Mometasone	-0.2	± 0.05
Placebo	-0.3	± 0.06

Change at Week 2 (AM)

Group	Value	95% CI
Mometasone	-0.4	± 0.08
Placebo	-0.3	± 0.09

Change at Week 3 (AM)

Group	Value	95% CI
Mometasone	-0.6	± 0.08
Placebo	-0.5	± 0.08

Change at Week 4 (AM)

Group	Value	95% CI
Mometasone	-0.6	± 0.08
Placebo	-0.6	± 0.09

Change at Final Week (AM)

Group	Value	95% CI
Mometasone	-0.5	± 0.07
Placebo	-0.5	± 0.09

Baseline (PM)

Group	Value	95% CI
Mometasone	1.5	± 0.08
Placebo	1.3	± 0.09

Change at Week 1 (PM)

Group	Value	95% CI
Mometasone	-0.3	± 0.06
Placebo	-0.4	± 0.07

Change From Baseline in AM and PM Difficulty Breathing Symptom Score Secondary · Baseline up to Week 4

Difficulty breathing is an asthma symptom assessed by participants using diary cards to record morning and evening difficulty breathing (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her difficulty breathing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Difficulty breathing was rated on a 4-point scale (0=no symptom \[best score\] to 3=symptoms were hard to tolerate and interfered with daily life activity \[worst score\]). The Final Week was the final 7 d

Baseline (AM)

Group	Value	95% CI
Mometasone	1.7	± 0.06
Placebo	1.6	± 0.07

Change at Week 1 (AM)

Group	Value	95% CI
Mometasone	-0.3	± 0.06
Placebo	-0.3	± 0.07

Change at Week 2 (AM)

Group	Value	95% CI
Mometasone	-0.4	± 0.07
Placebo	-0.4	± 0.08

Change at Week 3 (AM)

Group	Value	95% CI
Mometasone	-0.7	± 0.07
Placebo	-0.6	± 0.08

Change at Week 4 (AM)

Group	Value	95% CI
Mometasone	-0.7	± 0.07
Placebo	-0.7	± 0.09

Change at Final Week (AM)

Group	Value	95% CI
Mometasone	-0.6	± 0.07
Placebo	-0.6	± 0.08

Baseline (PM)

Group	Value	95% CI
Mometasone	1.7	± 0.06
Placebo	1.6	± 0.07

Change at Week 1 (PM)

Group	Value	95% CI
Mometasone	-0.3	± 0.06
Placebo	-0.4	± 0.07

Change From Baseline in AM and PM Chest Tightness Symptom Score Secondary · Baseline up to Week 4

Chest tightness is an asthma symptom assessed by participants using diary cards to record morning and evening chest tightness (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her chest tightness for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). The severity of chest tightness was rated on a 4-point scale (0=no symptom \[best score\] to 3=symptoms were hard to tolerate and interfered with daily life activity \[worst score\]). The Final Week was the final 7 days

Baseline (AM)

Group	Value	95% CI
Mometasone	1.6	± 0.07
Placebo	1.6	± 0.08

Change at Week 1 (AM)

Group	Value	95% CI
Mometasone	-0.2	± 0.06
Placebo	-0.4	± 0.07

Change at Week 2 (AM)

Group	Value	95% CI
Mometasone	-0.3	± 0.08
Placebo	-0.4	± 0.09

Change at Week 3 (AM)

Group	Value	95% CI
Mometasone	-0.5	± 0.07
Placebo	-0.7	± 0.08

Change at Week 4 (AM)

Group	Value	95% CI
Mometasone	-0.5	± 0.07
Placebo	-0.7	± 0.08

Change at Final Week (AM)

Group	Value	95% CI
Mometasone	-0.4	± 0.07
Placebo	-0.6	± 0.08

Baseline (PM)

Group	Value	95% CI
Mometasone	1.6	± 0.07
Placebo	1.6	± 0.08

Change at Week 1 (PM)

Group	Value	95% CI
Mometasone	-0.3	± 0.06
Placebo	-0.5	± 0.07

Change From Baseline in Pulmonary Auscultation/Wheezing Assessment Secondary · Baseline, Day 15 and Day 29

Wheezing was assessed by the investigator or designee based upon pulmonary auscultation (listening with a stethoscope) and reported in the case report form as present or absent. The count of wheezing presence (yes, no) at visits was summarized.

Present at Baseline

Group	Value	95% CI
Mometasone	11
Placebo	9

Absent at Baseline

Group	Value	95% CI
Mometasone	101
Placebo	66

Present on Day 15

Group	Value	95% CI
Mometasone	8
Placebo	4

Absent on Day 15

Group	Value	95% CI
Mometasone	94
Placebo	68

Present on Day 29

Group	Value	95% CI
Mometasone	10
Placebo	3

Absent on Day 29

Group	Value	95% CI
Mometasone	98
Placebo	71

Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) Secondary · Baseline up to Week 4

The Total Nasal Symptom Severity (TNSS) is the sum of severity scores for 4 nasal symptoms: nasal rhinorrhea, nasal stuffiness/congestion, sneezing, and nasal itching as assessed in the participant diaries. The severity of each nasal symptom was rated on a 4-point scale (0=no symptom \[best score\] to 3=symptoms were hard to tolerate and interfered with daily life activity \[worst score\]); minimum TNSS=0; maximum TNSS=12. A decrease in TNSS indicated an improvement in nasal symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication,

Baseline (AM)

Group	Value	95% CI
Mometasone	8.4	± 0.19
Placebo	7.9	± 0.23

Week 1 (AM)

Group	Value	95% CI
Mometasone	-1.7	± 0.21
Placebo	-0.9	± 0.25

Week 2 (AM)

Group	Value	95% CI
Mometasone	-2.3	± 0.27
Placebo	-1.3	± 0.30

Week 3 (AM)

Group	Value	95% CI
Mometasone	-3.2	± 0.29
Placebo	-1.8	± 0.32

Week 4 (AM)

Group	Value	95% CI
Mometasone	-3.5	± 0.32
Placebo	-2.4	± 0.37

Final Week (AM)

Group	Value	95% CI
Mometasone	-3.1	± 0.29
Placebo	-2.2	± 0.35

Baseline (PM)

Group	Value	95% CI
Mometasone	8.2	± 0.20
Placebo	7.9	± 0.23

Week 1 (PM)

Group	Value	95% CI
Mometasone	-1.8	± 0.22
Placebo	-1.5	± 0.25

Change From Baseline in AM and PM Rhinorrhea Symptom Score Secondary · Baseline up to Week 4

Rhinorrhea is a symptom of seasonal allergic rhinitis (SAR) assessed by participants using diary cards to record morning and evening rhinorrhea (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her rhinorrhea for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Rhinorrhea was assessed on a 4-point scale (0=no symptom \[best score\] to 3=symptoms were hard to tolerate and interfered with daily life activity \[worst score\]). The Final Week was the final 7 days post

Baseline (AM)

Group	Value	95% CI
Mometasone	2.2	± 0.06
Placebo	2.1	± 0.07

Change at Week 1 (AM)

Group	Value	95% CI
Mometasone	-0.3	± 0.06
Placebo	-0.2	± 0.07

Change at Week 2 (AM)

Group	Value	95% CI
Mometasone	-0.5	± 0.08
Placebo	-0.3	± 0.09

Change at Week 3 (AM)

Group	Value	95% CI
Mometasone	-0.7	± 0.09
Placebo	-0.4	± 0.10

Change at Week 4 (AM)

Group	Value	95% CI
Mometasone	-0.9	± 0.09
Placebo	-0.5	± 0.11

Change at Final Week (AM)

Group	Value	95% CI
Mometasone	-0.8	± 0.09
Placebo	-0.5	± 0.10

Baseline (PM)

Group	Value	95% CI
Mometasone	2.1	± 0.06
Placebo	2.0	± 0.07

Change at Week 1 (PM)

Group	Value	95% CI
Mometasone	-0.4	± 0.06
Placebo	-0.3	± 0.07

Change From Baseline in AM and PM Nasal Itching Symptom Score Secondary · Baseline up to Week 4

Nasal itching is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal itching (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal itching for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom \[best score\] to 3=symptoms were hard to tolerate and interfered with daily life activity \[worst score\]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was

Baseline (AM)

Group	Value	95% CI
Mometasone	2.0	± 0.07
Placebo	1.9	± 0.08

Change at Week 1 (AM)

Group	Value	95% CI
Mometasone	-0.4	± 0.07
Placebo	-0.2	± 0.08

Change at Week 2 (AM)

Group	Value	95% CI
Mometasone	-0.6	± 0.08
Placebo	-0.3	± 0.09

Change at Week 3 (AM)

Group	Value	95% CI
Mometasone	-0.9	± 0.08
Placebo	-0.5	± 0.09

Change at Week 4 (AM)

Group	Value	95% CI
Mometasone	-0.9	± 0.09
Placebo	-0.6	± 0.11

Change at Final Week (AM)

Group	Value	95% CI
Mometasone	-0.8	± 0.09
Placebo	-0.5	± 0.10

Baseline (PM)

Group	Value	95% CI
Mometasone	1.7	± 0.07
Placebo	1.5	± 0.08

Change at Week 1 (PM)

Group	Value	95% CI
Mometasone	-0.4	± 0.06
Placebo	-0.3	± 0.07

Change From Baseline in AM and PM Nasal Sneezing Symptom Score Secondary · Baseline up to Week 4

Nasal sneezing is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal sneezing (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal sneezing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom \[best score\] to 3=symptoms a were hard to tolerate and interfered with daily life activity \[worst score\]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20

Baseline (AM)

Group	Value	95% CI
Mometasone	1.8	± 0.07
Placebo	1.7	± 0.08

Change at Week 1 (AM)

Group	Value	95% CI
Mometasone	-0.5	± 0.07
Placebo	-0.2	± 0.08

Change at Week 2 (AM)

Group	Value	95% CI
Mometasone	-0.6	± 0.08
Placebo	-0.6	± 0.09

Change at Week 3 (AM)

Group	Value	95% CI
Mometasone	-0.9	± 0.08
Placebo	-0.4	± 0.09

Change at Week 4 (AM)

Group	Value	95% CI
Mometasone	-0.9	± 0.09
Placebo	-0.6	± 0.10

Change at Final Week (AM)

Group	Value	95% CI
Mometasone	-0.8	± 0.08
Placebo	-0.6	± 0.10

Baseline (PM)

Group	Value	95% CI
Mometasone	1.9	± 0.06
Placebo	1.8	± 0.08

Change at Week 1 (PM)

Group	Value	95% CI
Mometasone	-0.5	± 0.07
Placebo	-0.4	± 0.08

Change From Baseline in AM and PM Nasal Congestion Symptom Score Secondary · Baseline up to Week 4

Nasal congestion is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal congestion (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal congestion for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom \[best score\] to 3=symptoms were hard to tolerate and interfered with daily life activity \[worst score\]). The Final Week was the final 7 days post Day 1 (e. g., if Da

Baseline (AM)

Group	Value	95% CI
Mometasone	2.3	± 0.05
Placebo	2.3	± 0.06

Change at Week 1 (AM)

Group	Value	95% CI
Mometasone	-0.4	± 0.06
Placebo	-0.3	± 0.07

Change at Week 2 (AM)

Group	Value	95% CI
Mometasone	-0.5	± 0.07
Placebo	-0.4	± 0.08

Change at Week 3 (AM)

Group	Value	95% CI
Mometasone	-0.7	± 0.08
Placebo	-0.5	± 0.09

Change at Week 4 (AM)

Group	Value	95% CI
Mometasone	-0.8	± 0.10
Placebo	-0.7	± 0.11

Change at Final Week (AM)

Group	Value	95% CI
Mometasone	-0.8	± 0.08
Placebo	-0.6	± 0.10

Baseline (PM)

Group	Value	95% CI
Mometasone	2.2	± 0.05
Placebo	2.2	± 0.06

Change at Week 1 (PM)

Group	Value	95% CI
Mometasone	-0.4	± 0.07
Placebo	-0.4	± 0.08

Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) Secondary · Baseline up to Week 4

Participants used a peak flow meter to measure the rate of air forcibly expelled from the lungs. They performed triplicate PEFR measurements in the morning prior to taking their study medication and again in the evening, and documented the highest of the three values in their diaries. A day with worsening asthma was any day during which a decrease from baseline in morning (AM) PEFR of more than 25% occurred. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, an

Baseline (AM)

Group	Value	95% CI
Mometasone	382.5	± 8.35
Placebo	362.3	± 9.97

Change at Week 1 (AM)

Group	Value	95% CI
Mometasone	0.9	± 2.83
Placebo	1.0	± 3.34

Change at Week 2 (AM)

Group	Value	95% CI
Mometasone	4.3	± 3.28
Placebo	4.1	± 3.74

Change at Week 3 (AM)

Group	Value	95% CI
Mometasone	7.7	± 3.34
Placebo	1.0	± 3.73

Change at Week 4 (AM)

Group	Value	95% CI
Mometasone	7.8	± 3.79
Placebo	3.3	± 4.35

Change at Final Week (AM)

Group	Value	95% CI
Mometasone	5.7	± 3.37
Placebo	4.6	± 3.97

Baseline (PM)

Group	Value	95% CI
Mometasone	394.4	± 8.18
Placebo	373.4	± 9.77

Change at Week 1 (PM)

Group	Value	95% CI
Mometasone	0.5	± 2.67
Placebo	4.3	± 3.15

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 59 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mometasone

Serious: 1/113 (1%)

Deaths: 0/113

Placebo

Serious: 1/75 (1%)

Deaths: 0/75

Serious adverse events (2 terms)

Reaction	System	Mometasone	Placebo
Fracture, bone	Injury, poisoning and procedural complications	—	—
Periodontitis	Gastrointestinal disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Mometasone	Placebo
Headache	General disorders	—	—

Most-reported serious reactions: Fracture, bone, Periodontitis.

Data from ClinicalTrials.gov NCT00070707 adverse events section.

Sponsor's own description

This study will compare mometasone nasal spray to placebo in treating the nasal and asthma symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant asthma.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00070707 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Organon and Co
Last refreshed: 5 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00070707.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00070707

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (2 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Mometasone

Other recruiting trials for Rhinitis, Allergic, Seasonal

Other Organon and Co trials

Verify against primary sources