Trial · NCT02833974
Effect of the GSK2245035 on the Allergen-induced Asthmatic Response
NCT02833974, Phase 2, Completed, GlaxoSmithKline; results first posted 2019-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of the GSK2245035 on the Allergen-induced Asthmatic Response. Trials, record NCT02833974. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02833974
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of the GSK2245035 on the Allergen-induced Asthmatic Response
- NCT number
- NCT02833974
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- GSK2245035 Nasal Spray Solution, Placebo Nasal Spray Solution
- First posted
- 2016-07-15
- Last updated
- 2021-03-26
- Other registries' IDs
- eudract:2015-005645-31
- Results first posted
- 2019-05-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum Forced Expiratory Volume in 1 Second (FEV1) Between 4-10 Hours Following Allergen Challenge One Week After Treatment | Week 9 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to bronchial allergen challenge (BAC) at the one-week follow-up visit (one week after the eighth dose of the study treatment). Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hours post-allergen challenge, inclusive of the 4 and 10 hours timepoints. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. Per-Protocol Population comprises of all randomized participants who received at least one dose of study treatment and commence a BAC at follow-up and comply with the protocol. |
| Primary | LAR: Absolute Change From Saline in Weighted Mean FEV1 Between 4-10 Hours Following Allergen Challenge One Week After Treatment | Week 9 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Weighted mean FEV1 over 4-10 hours post-allergen challenge includes all post-saline time points between 4 and 10 hours post-allergen challenge, inclusive of the 4 and 10 hours timepoints. The weighted mean FEV1 was derived by calculating the area under the curve, and dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. |
| Secondary | Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hours Following Allergen Challenge One Week After Treatment | Week 9 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Minimum FEV1 over 0-2 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 0 and 2 hours post-allergen challenge, inclusive of the 0 and 2 hours timepoints. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. |
| Secondary | EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hours Following Allergen Challenge One Week After Treatment. | Week 9 | FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Weighted mean FEV1 over 0-2 hours post-allergen challenge includes all post-saline time points between 0-2 hours post-allergen challenge, inclusive of 0 and 2 hours timepoints. The weighted mean FEV1 was derived by calculating the area under the curve, and dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 20 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported. |
| Secondary | Number of Participants With Abnormal Peak Expiratory Flow (PEF) | Up to Week 12 | The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated. Participants were instructed to record their PEF readings each morning and evening into the diary card that was provided by the investigator. The minimum and maximum range ranges for PEF were \<=205 and \>=980 liters per minute. |
| Secondary | Number of Participants Receiving Rescue Medication | Up to Week 20 | Salbutamol was administered as rescue medication only to participants who experienced serious discomfort. The data below exclude any Salbutamol administered as part of the planned study procedures (for example the Salbutamol administered after the Bronchial Allergen Challenge \[BAC\] is not counted as a rescue medication). |
| Secondary | Number of Participants With Hematology Values of Potential Clinical Concern | Up to Week 20 | Blood samples were collected for analysis of hematology parameters. Hematology parameters included hematocrit, hemoglobin, platelet count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, and red blood cells (RBC). |
| Secondary | Number of Participants With Clinical Chemistry Values of Potential Clinical Concern | Up to Week 8 | Blood samples were collected for analysis of clinical chemistry parameters. Clinical chemistry parameters included blood urea nitrogen, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, total and direct bilirubin, albumin, calcium, creatinine, glucose, potassium and sodium. |
| Secondary | Number of Participants With Abnormal Urine Analysis Findings | Up to Week 8 | Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum Forced Expiratory Volume in 1 Second (FEV1) Between 4-10 Hours Following Allergen Challenge One Week After Treatment | Week 9 | Per-Protocol Population. Only those participants with data available at specified time points were analyzed | Liters | MEAN |
| PRIMARY | LAR: Absolute Change From Saline in Weighted Mean FEV1 Between 4-10 Hours Following Allergen Challenge One Week After Treatment | Week 9 | Per-Protocol Population. Only those participants with data available at specified time points were analyzed | Liters | MEAN |
| SECONDARY | Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hours Following Allergen Challenge One Week After Treatment | Week 9 | Per-Protocol Population. Only those participants with data available at specified time points were analyzed | Liters | MEAN |
| SECONDARY | EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hours Following Allergen Challenge One Week After Treatment. | Week 9 | Per-Protocol Population. Only those participants with data available at specified time points were analyzed | Liters | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 20 | All Subjects Population comprise of all participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Peak Expiratory Flow (PEF) | Up to Week 12 | All Subjects Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Receiving Rescue Medication | Up to Week 20 | All Subjects Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hematology Values of Potential Clinical Concern | Up to Week 20 | All Subjects Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Chemistry Values of Potential Clinical Concern | Up to Week 8 | All Subjects Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Urine Analysis Findings | Up to Week 8 | All Subjects Population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum Forced Expiratory Volume in 1 Second (FEV1) Between 4-10 Hours Following Allergen Challenge One Week After Treatment | Placebo | -1.107 | Standard Deviation 0.7195 | Liters | |
| Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum Forced Expiratory Volume in 1 Second (FEV1) Between 4-10 Hours Following Allergen Challenge One Week After Treatment | GSK2245035 20 ng | -0.885 | Standard Deviation 0.5353 | Liters | |
| LAR: Absolute Change From Saline in Weighted Mean FEV1 Between 4-10 Hours Following Allergen Challenge One Week After Treatment | Placebo | -0.546 | Standard Deviation 0.3932 | Liters | |
| LAR: Absolute Change From Saline in Weighted Mean FEV1 Between 4-10 Hours Following Allergen Challenge One Week After Treatment | GSK2245035 20 ng | -0.576 | Standard Deviation 0.4018 | Liters | |
| Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hours Following Allergen Challenge One Week After Treatment | Placebo | -1.246 | Standard Deviation 0.6052 | Liters | |
| Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hours Following Allergen Challenge One Week After Treatment | GSK2245035 20 ng | -1.096 | Standard Deviation 0.4113 | Liters | |
| EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hours Following Allergen Challenge One Week After Treatment. | Placebo | -0.604 | Standard Deviation 0.2670 | Liters | |
| EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hours Following Allergen Challenge One Week After Treatment. | GSK2245035 20 ng | -0.587 | Standard Deviation 0.2388 | Liters | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Placebo | Any AE | 10 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | GSK2245035 20 ng | Any AE | 21 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 14 | |
| Overall Study | STARTED | GSK2245035 20 ng | 22 | |
| Overall Study | COMPLETED | Placebo | 13 | |
| Overall Study | COMPLETED | GSK2245035 20 ng | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | GSK2245035 20 ng | 3 |
Source ClinicalTrials.gov
Adverse events120
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 | Headache | Nervous system disorders | Placebo | 8 | 14 | |
| other | Headache | Nervous system disorders | GSK2245035 20 ng | 9 | 22 | |
| other | Dizziness | Nervous system disorders | Placebo | 1 | 14 | |
| other | Dizziness | Nervous system disorders | GSK2245035 20 ng | 0 | 22 | |
| other | Facial paralysis | Nervous system disorders | Placebo | 0 | 14 | |
| other | Facial paralysis | Nervous system disorders | GSK2245035 20 ng | 1 | 22 | |
| other | Parosmia | Nervous system disorders | Placebo | 1 | 14 | |
| other | Parosmia | Nervous system disorders | GSK2245035 20 ng | 0 | 22 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 14 | |
| other | Nasopharyngitis | Infections and infestations | GSK2245035 20 ng | 6 | 22 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 14 |
| Total, all-cause mortality | GSK2245035 20 ng | 0 | 22 |
| Total, other adverse events | Placebo | 10 | 14 |
| Total, other adverse events | GSK2245035 20 ng | 21 | 22 |
| Total, serious adverse events | Placebo | 0 | 14 |
| Total, serious adverse events | GSK2245035 20 ng | 0 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33166307 | 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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK2245035 20 ng vs Placebo: Number of Participants With Abnormal Urine Analysis Findings | Trial comparisons |
| GSK2245035 20 ng vs Placebo: Number of Participants With Clinical Chemistry Values of Potential Clinical Concern | Trial comparisons |
| GSK2245035 20 ng vs Placebo: Number of Participants With Hematology Values of Potential Clinical Concern | Trial comparisons |
| GSK2245035 20 ng vs Placebo: Number of Participants Receiving Rescue Medication | Trial comparisons |
| GSK2245035 20 ng vs Placebo: deaths from any cause | Trial comparisons |
| GSK2245035 20 ng vs Placebo: Number of Participants With Abnormal Peak Expiratory Flow (PEF) | Trial comparisons |
| GSK2245035 20 ng vs Placebo: serious adverse events | 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.
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