Trial · NCT02991859
Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects
NCT02991859, Phase 2, Completed, GlaxoSmithKline; results first posted 2020-03-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects. Trials, record NCT02991859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02991859
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects
- NCT number
- NCT02991859
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- Fluticasone furoate (FF) Dry Powder Inhaler, Fluticasone propionate (FP) Dry Powder Inhaler, Budesonide (BUD) Turbuhaler, Placebo (ELLIPTA or DISKUS)
- First posted
- 2016-12-14
- Last updated
- 2020-07-31
- Other registries' IDs
- eudract:2016-003002-14
- Results first posted
- 2020-03-30
Source ClinicalTrials.gov
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | 12 hours post last dose on Day 7 | The percentage fall in FEV1 was calculated using highest FEV1 (post saline) minus highest FEV1 (post AMP) divided by highest FEV1 (post saline)\*100 where highest FEV1 (post saline) is the highest value of two FEV1 measurements at 60 and 180 seconds after the saline control, highest FEV1 (post AMP) is the highest value of the two FEV1 measurements at 60 and 180 seconds after the dose of AMP. Results are presented treatment wise. The analysis method was a 3 parameter Emax model with log 2 transformed AMP PC20 as the outcome variable, assuming common Emax across FF, FP and BUD, and with an unstructured variance-covariance matrix. Mean and 95% Confidence Interval (CI) presented are predicted estimate. |
| Primary | Cortisol Suppression 0-24 Hours Weighted Mean-Dose Response Analysis | Pre-dose PM dose on Day 6 to pre-dose PM dose Day 7 | Blood samples for measurement of plasma cortisol were collected at given time point. The weighted means were derived by calculating the area under the curve (AUC) over the 0-24-hour period using the trapezoidal rule, and then dividing it by the actual time interval. Results are presented treatment wise. Mean and 95% CI presented are predicted estimate. The analysis method was an inhibitory exponential power-law model with log e transformed cortisol as the outcome variable, assuming 100% inhibition at highest doses. |
| Primary | Theraputic Index of FF | 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7 | Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter\[nmol/L\]) divided by Dose at which 80% of the maximum effect is reached (ED80) for AMP PC20 for FF 25 mcg, FF 100 mcg, FF 200 mcg, FF 400 mcg, FF 800 mcg. Theraputic index has been presented. Only those participants with data available at the specified time points were analyzed. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively. |
| Primary | Theraputic Index of FP | 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7 | Therapeutic Index was calculated by Dose at which 20% of the maximum effect is reached (ED20) for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter\[nmol/L\]) divided by ED80 for AMP PC20 for FP 50 mcg, FP 200 mcg, FP 500 mcg, FP 1000 mcg, FP 2000 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively. |
| Primary | Theraputic Index of BUD | 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7 | Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter\[nmol/L\]) divided by ED80 for AMP PC20 for BUD 100 mcg, BUD 400 mcg, BUD 800 mcg, BUD 1600 mcg, BUD 3200 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively. |
| Secondary | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) | Up to Week 18 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that at any dose results in death, Is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Results are presented treatment wise. |
| Secondary | Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1 | Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in period 1 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). |
| Secondary | PEFR as a Measure of Safety and Tolerability of Placebo in Period 2 | Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in Period 2 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1 | Day 2,3,4,5,6,7 PM in period 1 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
| Secondary | PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2 | Day 2,3,4,5,6,7 PM in period 2 | PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 registered outcomesOutcomes50
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | 12 hours post last dose on Day 7 | Pharmacodymanic (PD) population. Participants who were randomized and received at least one dose of trial medication and also have at least one post dose PD measurement. Only those participants with data available at the specified time points were analyzed. | Milligrams per milliliter | MEAN |
| PRIMARY | Cortisol Suppression 0-24 Hours Weighted Mean-Dose Response Analysis | Pre-dose PM dose on Day 6 to pre-dose PM dose Day 7 | PD population. Only those participants with data available for each dose escalation phase were analyzed. | nanomoles per liter | MEAN |
| PRIMARY | Theraputic Index of FF | 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7 | PD population. Only those participants with data available at the specified time points were analyzed. | Ratio | NUMBER |
| PRIMARY | Theraputic Index of FP | 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7 | PD population. Only those participants with data available at the specified time points were analyzed. | Ratio | NUMBER |
| PRIMARY | Theraputic Index of BUD | 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7 | PD population. Only those participants with data available at the specified time points were analyzed. | Ratio | NUMBER |
| SECONDARY | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) | Up to Week 18 | All Subjects Population was consisted of all participants who were randomized and who received at least one dose of trial medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1 | Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in period 1 | All subjects Population. | Liters per minute | MEAN |
| SECONDARY | PEFR as a Measure of Safety and Tolerability of Placebo in Period 2 | Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in Period 2 | All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles). | Liters per minute | MEAN |
| SECONDARY | PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1 | Day 2,3,4,5,6,7 PM in period 1 | All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | Liters per minute | MEAN |
| SECONDARY | PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2 | Day 2,3,4,5,6,7 PM in period 2 | All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles). | Liters per minute | MEAN |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 outcomesResults by group587
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | FF 25 mcg | 33.45 | 95% Confidence Interval 19.10 to 58.60 | Milligrams per milliliter | |
| Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | FF 100 mcg | 81.45 | 95% Confidence Interval 44.65 to 148.58 | Milligrams per milliliter | |
| Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | FF 200 mcg | 115.69 | 95% Confidence Interval 66.82 to 200.31 | Milligrams per milliliter | |
| Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | FF 400 mcg | 145.97 | 95% Confidence Interval 85.02 to 250.59 | Milligrams per milliliter | |
| Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | FF 800 mcg | 167.26 | 95% Confidence Interval 95.36 to 293.37 | Milligrams per milliliter | |
| Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | FP 50 mcg | 15.19 | 95% Confidence Interval 10.80 to 21.36 | Milligrams per milliliter | |
| Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | FP 200 mcg | 20.47 | 95% Confidence Interval 13.94 to 30.07 | Milligrams per milliliter | |
| Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | FP 500 mcg | 31.39 | 95% Confidence Interval 18.88 to 52.19 | Milligrams per milliliter | |
| Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | FP 1000 mcg | 48.67 | 95% Confidence Interval 27.30 to 86.78 | Milligrams per milliliter | |
| Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis | FP 2000 mcg | 76.35 | 95% Confidence Interval 43.21 to 134.91 | Milligrams per milliliter |
1 to 10 of 587Source ClinicalTrials.gov
See all 587 results by groupParticipant flow561
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1,Escalation Phase 1,Upto Day 7 | STARTED | Arm AB - FF Followed by FP | 2 | |
| Period 1,Escalation Phase 1,Upto Day 7 | STARTED | Arm AC - FF Followed by BUD | 3 | |
| Period 1,Escalation Phase 1,Upto Day 7 | STARTED | Arm AD - FF Followed by ELLIPTA Placebo | 2 | |
| Period 1,Escalation Phase 1,Upto Day 7 | STARTED | Arm BA - FP Followed by FF | 2 | |
| Period 1,Escalation Phase 1,Upto Day 7 | STARTED | Arm BC - FP Followed by BUD | 3 | |
| Period 1,Escalation Phase 1,Upto Day 7 | STARTED | Arm BE - FP Followed by DISKUS Placebo | 3 | |
| Period 1,Escalation Phase 1,Upto Day 7 | STARTED | Arm CA - BUD Followed by FF | 2 | |
| Period 1,Escalation Phase 1,Upto Day 7 | STARTED | Arm CB - BUD Followed by FP | 2 | |
| Period 1,Escalation Phase 1,Upto Day 7 | STARTED | Arm CE - BUD Followed by DISKUS Placebo | 2 | |
| Period 1,Escalation Phase 1,Upto Day 7 | STARTED | Arm DA - ELLIPTA Placebo Followed by FF | 2 |
1 to 10 of 561Source ClinicalTrials.gov
See all 561 participant flowAdverse events1,056
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 | 4 | 17 | 8 |
| other | Headache | Nervous system disorders | FF 25 mcg | 5 | 20 | 5 |
| other | Headache | Nervous system disorders | FF 100 mcg | 3 | 19 | 3 |
| other | Headache | Nervous system disorders | FF 200 mcg | 1 | 19 | 1 |
| other | Headache | Nervous system disorders | FF 400 mcg | 2 | 18 | 2 |
| other | Headache | Nervous system disorders | FF 800 mcg | 1 | 18 | 1 |
| other | Headache | Nervous system disorders | FP 50 mcg | 2 | 21 | 2 |
| other | Headache | Nervous system disorders | FP 200 mcg | 0 | 20 | 0 |
| other | Headache | Nervous system disorders | FP 500 mcg | 0 | 20 | 0 |
| other | Headache | Nervous system disorders | FP 1000 mcg | 0 | 18 | 0 |
1 to 10 of 1,056Source ClinicalTrials.gov
See all 1,056 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 17 |
| Total, all-cause mortality | FF 25 mcg | 0 | 20 |
| Total, all-cause mortality | FF 100 mcg | 0 | 19 |
| Total, all-cause mortality | FF 200 mcg | 0 | 19 |
| Total, all-cause mortality | FF 400 mcg | 0 | 18 |
| Total, all-cause mortality | FF 800 mcg | 0 | 18 |
| Total, all-cause mortality | FP 50 mcg | 0 | 21 |
| Total, all-cause mortality | FP 200 mcg | 0 | 20 |
| Total, all-cause mortality | FP 500 mcg | 0 | 20 |
| Total, all-cause mortality | FP 1000 mcg | 0 | 18 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32484940 | DERIVED |
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/NCT02991859
GET https://conductscience.org/api/trials/v1/NCT02991859/registered?page=2