Trial · NCT00972504
723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover
NCT00972504, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-08-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover. Trials, record NCT00972504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00972504
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover
- NCT number
- NCT00972504
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Rhinitis, Allergic, Seasonal
- Interventions
- GSK835726 10mg, GSK1004723 1000mcg, Cetirizine 10mg, placebo
- First posted
- 2009-09-07
- Last updated
- 2017-08-02
- Results first posted
- 2017-08-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Day 3 of each treatment period (approximately up to 63 days) | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean. |
| Secondary | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Day 3 of each treatment period (approximately up to 63 days) | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed to produce the TNSS at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean. |
| Secondary | Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Day 3 of each treatment period (approximately up to 63 days) | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Wet tissue weight assessments was measured as a surrogate marker of nasal secretion at 60, 120, 180, 240, 300 and 360 minutes. The adjusted mean is provided as least square mean. |
| Secondary | Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Day 3 of each treatment period (approximately up to 63 days) | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal congestion was measured on 0-10 centimeter VAS scale (0: no symptoms and 10: the worst possible symptoms) with low score indicates well-being and higher values indicate greater congestion. It was measured at 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes. The adjusted mean is provided as least square mean. |
| Secondary | Mean Forced Expiratory Volume in 1 Second (FEV1) | Day 3 of each treatment period (approximately up to 63 days) | On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. FEV1 was measured at pre-challenge, 60, 120, 180, 240, 300 and 360 minutes. |
| Secondary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | approximately up to 63 days | An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or is associated with liver injury and impaired liver function defined as: alanine aminotransferase \>=3 times upper limit of normal (ULN), and total bilirubin \>=2 times ULN or international normalized ratio more than 1.5. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Day 3 of each treatment period (approximately up to 63 days) | The all subjects population was used defined as all participants who receive at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Day 3 of each treatment period (approximately up to 63 days) | All Subjects population. Only those participants with data available at the indicated time points were analyzed. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Day 3 of each treatment period (approximately up to 63 days) | All Subjects population. Only those participants with data available at the indicated time points were analyzed. | Grams | LEAST_SQUARES_MEAN |
| SECONDARY | Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Day 3 of each treatment period (approximately up to 63 days) | All Subjects population. Only those participants with data available at the indicated time points were analyzed. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Forced Expiratory Volume in 1 Second (FEV1) | Day 3 of each treatment period (approximately up to 63 days) | All Subjects population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects population. | Liters | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | approximately up to 63 days | All Subjects population. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Placebo | 4.9 | 95% Confidence Interval 4.4 to 5.4 | Score on a scale | |
| Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | GSK1004723 1000 µg Once Daily | 4.2 | 95% Confidence Interval 3.7 to 4.8 | Score on a scale | |
| Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | GSK835726 10 mg Once Daily | 3.6 | 95% Confidence Interval 3.1 to 4.1 | Score on a scale | |
| Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Cetirizine 10 mg Once Daily | 3.5 | 95% Confidence Interval 3.0 to 4.1 | Score on a scale | |
| Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Placebo | Nasal Blockage | 1.5 | 95% Confidence Interval 1.3 to 1.7 | Score on a scale |
| Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | GSK1004723 1000 µg Once Daily | Nasal Blockage | 1.7 | 95% Confidence Interval 1.5 to 1.8 | Score on a scale |
| Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | GSK835726 10 mg Once Daily | Nasal Blockage | 1.3 | 95% Confidence Interval 1.1 to 1.4 | Score on a scale |
| Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Cetirizine 10 mg Once Daily | Nasal Blockage | 1.3 | 95% Confidence Interval 1.1 to 1.4 | Score on a scale |
| Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | Placebo | Rhinorrhoea | 1.5 | 95% Confidence Interval 1.3 to 1.7 | Score on a scale |
| Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3 | GSK1004723 1000 µg Once Daily | Rhinorrhoea | 1.3 | 95% Confidence Interval 1.1 to 1.4 | Score on a scale |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall Study | 54 | |
| Overall Study | COMPLETED | Overall Study | 51 | |
| Overall Study | NOT COMPLETED | Overall Study | 3 |
Source ClinicalTrials.gov
Adverse events164
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 | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 52 | |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | GSK1004723 1000 µg Once Daily | 47 | 54 | |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | GSK835726 10 mg Once Daily | 1 | 53 | |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Cetirizine 10 mg Once Daily | 1 | 52 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 52 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | GSK1004723 1000 µg Once Daily | 4 | 54 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | GSK835726 10 mg Once Daily | 0 | 53 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Cetirizine 10 mg Once Daily | 1 | 52 | |
| other | Nasal dryness | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 52 | |
| other | Nasal dryness | Respiratory, thoracic and mediastinal disorders | GSK1004723 1000 µg Once Daily | 4 | 54 |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 52 |
| Total, all-cause mortality | GSK1004723 1000 µg Once Daily | 0 | 54 |
| Total, all-cause mortality | GSK835726 10 mg Once Daily | 0 | 53 |
| Total, all-cause mortality | Cetirizine 10 mg Once Daily | 0 | 52 |
| Total, other adverse events | Placebo | 15 | 52 |
| Total, other adverse events | GSK1004723 1000 µg Once Daily | 53 | 54 |
| Total, other adverse events | GSK835726 10 mg Once Daily | 13 | 53 |
| Total, other adverse events | Cetirizine 10 mg Once Daily | 17 | 52 |
| Total, serious adverse events | Placebo | 0 | 52 |
| Total, serious adverse events | GSK1004723 1000 µg Once Daily | 0 | 54 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22212854 | BACKGROUND |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00972504
GET https://conductscience.org/api/trials/v1/NCT00972504/results?page=2