Trial · NCT02397915
Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays
NCT02397915, Phase 4, Completed, GlaxoSmithKline; results first posted 2016-02-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays. Trials, record NCT02397915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02397915
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays
- NCT number
- NCT02397915
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 300 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Rhinitis, Allergic, Perennial and Seasonal
- Interventions
- FF nasal spray, MF nasal spray
- First posted
- 2015-03-25
- Last updated
- 2018-01-09
- Results first posted
- 2016-02-29
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | Approximately four minutes after the administration of the second treatment | An overall preference questionnaire (OPQ) was used to evaluate participants' preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment in Period 2. Overall participant preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg's method. |
| Secondary | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Approximately four minutes after the administration of the second treatment | An overall preference questionnaire (OPQ) was used to evaluate participants' attribute preference for nasal spray therapy for the given treatment. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. Products attributes included scent/odor, immediate taste, after taste, less drip through throat (LDTT), less run out of nose (LRON), more soothing, less irritating and urge to sneeze (UTS). The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment (tmt) in Period 2. Overall participant preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country (ctry) and symptomatology (sym). All preference p-values were also adjusted for multiplicity using Hochberg's method. |
| Secondary | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Immediately following each treatment in Period 1 and 2 | Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. scent/odor, using immediate attributes questionnaire, Question 1, "Did product have a scent/odor?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance (ANOVA) mixed model with participant as a random effect, and country, treatment, period, and Baseline (BL) rhinitis symptomatology subgroup (subgrp), and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method. |
| Secondary | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Immediately following each treatment in Period 1 and 2 | Immediate attributes questionnaire (ques) was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using immediate attributes ques, Question 2, "How satisfied with scent/odor?" are summarized. The immediate' attributes ques was completed immediately following each treatment (trt) in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, trt, period, and BL rhinitis symptomatology subgroup, and trt sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method. |
| Secondary | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Immediately following each treatment in Period 1 and 2 | Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using immediate attributes questionnaire, Question 3, "How satisfied not to have scent/odor?" are summarized. The immediate' attributes questionnaire was completed immediately following each trt in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, trt, period, and BL rhinitis symptomatology subgroup, and trt sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method. |
| Secondary | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Immediately following each treatment in Period 1 and 2 | Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using immediate attributes questionnaire, Question 4, "Did product have an immediate taste?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method. |
| Secondary | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Immediately following each treatment in Period 1 and 2 | Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using immediate attributes questionnaire, Question 5, "How satisfied with immediate taste?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method. |
| Secondary | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Immediately following each treatment in Period 1 and 2 | Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 6, "Did medicine run down throat?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method. |
| Secondary | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Immediately following each treatment in Period 1 and 2 | Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 7, "Did medicine run out of nose?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method. |
| Secondary | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Immediately following each treatment in Period 1 and 2 | Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 8, "Did product feel soothing?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | Approximately four minutes after the administration of the second treatment | Per Protocol (PP) Population: comprised of all participants who completed both treatment Periods and the questionnaires associated with them. | Participants | NUMBER |
| SECONDARY | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Approximately four minutes after the administration of the second treatment | PP Population | Participants | NUMBER |
| SECONDARY | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Immediately following each treatment in Period 1 and 2 | PP Population | Participants | NUMBER |
| SECONDARY | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Immediately following each treatment in Period 1 and 2 | PP Population. Only participants responded to the question were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Immediately following each treatment in Period 1 and 2 | PP Population. Only participants responded to the question were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Immediately following each treatment in Period 1 and 2 | PP Population | Participants | NUMBER |
| SECONDARY | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Immediately following each treatment in Period 1 and 2 | PP Population. Only participants responded to the question were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Immediately following each treatment in Period 1 and 2 | PP Population | Participants | NUMBER |
| SECONDARY | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Immediately following each treatment in Period 1 and 2 | PP Population | Participants | NUMBER |
| SECONDARY | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Immediately following each treatment in Period 1 and 2 | PP Population | Participants | NUMBER |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group348
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | FF 110 µg /MF 200 µg | FF 110 µg | 96 | Participants | |
| Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | MF 200 µg /FF 110 µg | FF 110 µg | 59 | Participants | |
| Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | FF 110 µg /MF 200 µg | MF 200 µg | 30 | Participants | |
| Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | MF 200 µg /FF 110 µg | MF 200 µg | 57 | Participants | |
| Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | FF 110 µg /MF 200 µg | No preference | 12 | Participants | |
| Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | MF 200 µg /FF 110 µg | No preference | 22 | Participants | |
| Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | FF 110 µg /MF 200 µg | Scent/odor, FF110 µg | 53 | Participants | |
| Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | MF 200 µg /FF 110 µg | Scent/odor, FF110 µg | 28 | Participants | |
| Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | FF 110 µg /MF 200 µg | Scent/odor, MF 200 µg | 21 | Participants | |
| Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | MF 200 µg /FF 110 µg | Scent/odor, MF 200 µg | 31 | Participants |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Period 1: FF 110 µg | 150 | |
| Period 1 | STARTED | Period 1: MF 200 µg | 150 | |
| Period 1 | STARTED | Period 2: MF 200 µg | 0 | |
| Period 1 | STARTED | Period 2: FF 110 µg | 0 | |
| Period 1 | COMPLETED | Period 1: FF 110 µg | 149 | |
| Period 1 | COMPLETED | Period 1: MF 200 µg | 149 | |
| Period 1 | COMPLETED | Period 2: MF 200 µg | 0 | |
| Period 1 | COMPLETED | Period 2: FF 110 µg | 0 | |
| Period 1 | NOT COMPLETED | Period 1: FF 110 µg | 1 | |
| Period 1 | NOT COMPLETED | Period 1: MF 200 µg | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | FF 110 µg | 1 | 298 | |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MF 200 µg | 4 | 298 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | FF 110 µg | 0 | 298 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | MF 200 µg | 3 | 298 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FF 110 µg | ||
| Total, all-cause mortality | MF 200 µg | ||
| Total, other adverse events | FF 110 µg | 1 | 298 |
| Total, other adverse events | MF 200 µg | 5 | 298 |
| Total, serious adverse events | FF 110 µg | 0 | 298 |
| Total, serious adverse events | MF 200 µg | 0 | 298 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| FF 110 µg vs MF 200 µg: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02397915
GET https://conductscience.org/api/trials/v1/NCT02397915/registered?page=2