Adults 18 to 65, any sex, with 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.
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 AnalysisPrimary· 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 unstr
Group
Value
95% CI
FF 25 mcg
33.45
19.10 – 58.60
FF 100 mcg
81.45
44.65 – 148.58
FF 200 mcg
115.69
66.82 – 200.31
FF 400 mcg
145.97
85.02 – 250.59
FF 800 mcg
167.26
95.36 – 293.37
FP 50 mcg
15.19
10.80 – 21.36
FP 200 mcg
20.47
13.94 – 30.07
FP 500 mcg
31.39
18.88 – 52.19
FP 1000 mcg
48.67
27.30 – 86.78
FP 2000 mcg
76.35
43.21 – 134.91
BUD 100 mcg
16.00
11.41 – 22.44
BUD 400 mcg
23.91
15.08 – 37.90
Cortisol Suppression 0-24 Hours Weighted Mean-Dose Response AnalysisPrimary· 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.
Group
Value
95% CI
FF 25 mcg
172.73
159.88 – 186.62
FF 100 mcg
163.03
151.01 – 176.02
FF 200 mcg
150.95
139.48 – 163.37
FF 400 mcg
129.40
117.82 – 142.12
FF 800 mcg
95.09
82.26 – 109.93
FP 50 mcg
173.04
160.15 – 186.97
FP 200 mcg
164.22
152.11 – 177.29
FP 500 mcg
147.89
136.59 – 160.13
FP 1000 mcg
124.21
112.88 – 136.68
FP 2000 mcg
87.62
75.37 – 101.85
BUD 100 mcg
169.87
157.23 – 183.52
BUD 400 mcg
152.50
141.26 – 164.63
Theraputic Index of FFPrimary· 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.
Group
Value
95% CI
Fluticasone Propionate (FP)
1.49
Theraputic Index of FPPrimary· 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.
Group
Value
95% CI
Fluticasone Propionate (FP)
0.15
Theraputic Index of BUDPrimary· 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.
Group
Value
95% CI
Budesonide (BUD)
0.11
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)Secondary· 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.
Any AEs
Group
Value
95% CI
Placebo
10
FF 25 mcg
6
FF 100 mcg
8
FF 200 mcg
7
FF 400 mcg
6
FF 800 mcg
7
FP 50 mcg
10
FP 200 mcg
4
FP 500 mcg
4
FP 1000 mcg
8
FP 2000 mcg
6
BUD 100 mcg
6
Any SAEs
Group
Value
95% CI
Placebo
0
FF 25 mcg
0
FF 100 mcg
0
FF 200 mcg
0
FF 400 mcg
0
FF 800 mcg
0
FP 50 mcg
0
FP 200 mcg
0
FP 500 mcg
0
FP 1000 mcg
0
FP 2000 mcg
0
BUD 100 mcg
0
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1Secondary· 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).
Day 2, PM, n=12
Group
Value
95% CI
Placebo
522.5
± 25.4
Day 3, PM, n=12
Group
Value
95% CI
Placebo
517.5
± 27.0
Day 4, PM, n=12
Group
Value
95% CI
Placebo
514.2
± 27.8
Day 5,PM, n=12
Group
Value
95% CI
Placebo
521.7
± 24.2
Day 6, PM, n=12
Group
Value
95% CI
Placebo
522.5
± 29.1
Day 7, PM, n=12
Group
Value
95% CI
Placebo
539.2
± 32.3
Day 8, PM, n=12
Group
Value
95% CI
Placebo
530.8
± 27.8
Day 9, AM, n=5
Group
Value
95% CI
Placebo
576.0
± 37.5
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2Secondary· 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.
Day 2, PM, n=4
Group
Value
95% CI
Placebo
422.5
± 28.9
Day 3, PM, n=4
Group
Value
95% CI
Placebo
415.0
± 27.2
Day 4, PM, n=4
Group
Value
95% CI
Placebo
398.8
± 26.6
Day 5,PM, n=4
Group
Value
95% CI
Placebo
407.5
± 37.5
Day 6, PM, n=4
Group
Value
95% CI
Placebo
411.3
± 29.0
Day 7, PM, n=4
Group
Value
95% CI
Placebo
410.0
± 36.7
Day 8, PM, n=4
Group
Value
95% CI
Placebo
415.0
± 36.1
Day 9, AM, n=2
Group
Value
95% CI
Placebo
430.0
± 80.0
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1Secondary· 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.
Day 2, PM, n=14
Group
Value
95% CI
FF 25 mcg
479.6
± 30.9
Day 3, PM, n=14
Group
Value
95% CI
FF 25 mcg
475.7
± 32.9
Day 4, PM, n=14
Group
Value
95% CI
FF 25 mcg
473.0
± 31.1
Day 5,PM, n=14
Group
Value
95% CI
FF 25 mcg
476.1
± 26.6
Day 6, PM, n=13
Group
Value
95% CI
FF 25 mcg
503.1
± 24.6
Day 7, PM, n=13
Group
Value
95% CI
FF 25 mcg
502.3
± 28.1
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2Secondary· 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.
Day 2, PM, n=5
Group
Value
95% CI
FF 25 mcg
572.0
± 48.9
Day 3, PM, n=5
Group
Value
95% CI
FF 25 mcg
570.0
± 54.5
Day 4, PM, n=5
Group
Value
95% CI
FF 25 mcg
568.0
± 55.0
Day 5,PM, n=5
Group
Value
95% CI
FF 25 mcg
573.0
± 54.9
Day 6, PM, n=6
Group
Value
95% CI
FF 25 mcg
550.8
± 52.2
Day 7, PM, n=6
Group
Value
95% CI
FF 25 mcg
560.0
± 45.3
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1Secondary· Day 8,9,10,11,12,13,14 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.
Day 8, PM, n=13
Group
Value
95% CI
FF 100 mcg
497.3
± 24.9
Day 9, PM, n=13
Group
Value
95% CI
FF 100 mcg
500.4
± 28.2
Day 10, PM, n=13
Group
Value
95% CI
FF 100 mcg
491.2
± 31.0
Day 11, PM, n=12
Group
Value
95% CI
FF 100 mcg
507.5
± 30.9
Day 12, PM, n=13
Group
Value
95% CI
FF 100 mcg
500.2
± 30.2
Day 13, PM, n=13
Group
Value
95% CI
FF 100 mcg
515.4
± 29.7
Day 14, PM, n=13
Group
Value
95% CI
FF 100 mcg
505.8
± 28.7
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2Secondary· Day 8,9,10,11,12,13,14 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.
Day 8, PM
Group
Value
95% CI
FF 100 mcg
540.0
± 43.8
Day 9, PM
Group
Value
95% CI
FF 100 mcg
567.5
± 42.6
Day 10, PM
Group
Value
95% CI
FF 100 mcg
556.7
± 43.4
Day 11, PM
Group
Value
95% CI
FF 100 mcg
561.7
± 44.6
Day 12, PM
Group
Value
95% CI
FF 100 mcg
573.3
± 50.0
Day 13, PM
Group
Value
95% CI
FF 100 mcg
563.3
± 53.0
Day 14, PM
Group
Value
95% CI
FF 100 mcg
555.8
± 46.9
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious adverse events and non-serious adverse events were collected up to 18 weeks..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a randomized, placebo-controlled, 2-period crossover, escalating repeat dose study, aiming to investigate whether higher potency of different inhaled corticosteroid confers an improvement in the topical efficacy to systemic activity ratio in asthmatic subjects. It will compare the dose response for topical efficacy via airway responsiveness (to adenosine-5'-monophosphate \[AMP\] challenge), and the dose response for systemic activity via 24 hour plasma cortisol suppression, and thereby compare the relative therapeutic index, for the following inhaled corticosteroids: fluticasone furoate (FF), fluticasone propionate (FP) and budesonide (BUD). There will be a screening visit 4 - 42 days before the first dose of study treatment, and AMP challenge Provocative concentration 20 (PC20) of \<=80 milligrams per milliliter (mg/mL) at screening visit 2 i.e. at 4 - 14 days before the first dose of study treatment. Subjects will be randomized to one of 5 or 12 treatment sequences, and will have one or two treatment periods, each comprising 5 consecutive 7-day phases of escalating doses of either FF, FP, BUD or placebo. There will be a 25- to 42-day washout period between treatment periods. The study duration for each subject will be approximately 13 or 24 weeks including the follow-up period.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t
· Phase 2
· recruiting
NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being
· NA
· recruiting
NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
· recruiting
NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ
· Phase 1
· recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam
· Phase 2, PHASE3
· not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose
· Phase 1
· not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH
· Phase 3
· not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
· not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 31 July 2020
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/NCT02991859.