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Trial Outcomes & Findings for The Clinical Effect of Monodisperse Fluticasone Propionate in Asthma (NCT NCT01662778)

NCT ID: NCT01662778

Last Updated: 2019-11-18

Results Overview

The concentration of Adenosine Monophosphate (AMP), measured in mg/ml, required to see a 20% fall in the patient's forced expiratory volume in 1 second (FEV1) is measured after taking FP aerosol. AMP is a bronchoconstrictor agent (ie it narrows the airways. We would expect that more would be necessary to produce the same 20% fall in FEV1 after receiving the FP than before due to the reduction in airways inflammation. This change is the primary outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

2 hours

Results posted on

2019-11-18

Participant Flow

Participant milestones

Participant milestones
Measure
First Monodisperse Fluticasone Propionate 6.0 Microns
First 50 micrograms of Monodisperse Fluticasone Propionate delivered as 6.0 microns, then 50 micrograms of Monodisperse Fluticasone Propionate 1.5microns, next is Placebo STAG, and Metered dose inhaler of Fluticasone Propionate last
First Monodisperse Fluticasone Propionate 1.5microns
First 50 micrograms of Monodisperse Fluticasone Propionate delivered as 1.5 microns, then 50 micrograms of Monodisperse Fluticasone Propionate 6.0 microns, next is Placebo STAG, and Metered dose inhaler of Fluticasone Propionate last
First Placebo STAG
First Placebo STAG, then 50 micrograms of Monodisperse Fluticasone Propionate delivered as 1.5 microns, then 50 micrograms of Monodisperse Fluticasone Propionate 6.0 microns, and Metered dose inhaler of Fluticasone Propionate last
First Metered Dose Inhaler of Fluticasone Propionate
First Metered dose inhaler of Fluticasone Propionate, then Placebo STAG, then 50 micrograms of Monodisperse Fluticasone Propionate delivered as 1.5 microns, and 50 micrograms of Monodisperse Fluticasone Propionate 6.0 microns last
Period 1
STARTED
6
5
6
4
Period 1
COMPLETED
6
5
6
4
Period 1
NOT COMPLETED
0
0
0
0
Period 2
STARTED
6
5
6
4
Period 2
COMPLETED
6
5
6
4
Period 2
NOT COMPLETED
0
0
0
0
Period 3
STARTED
6
5
6
4
Period 3
COMPLETED
6
5
6
4
Period 3
NOT COMPLETED
0
0
0
0
Period 4
STARTED
6
5
6
4
Period 4
COMPLETED
6
5
6
4
Period 4
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Clinical Effect of Monodisperse Fluticasone Propionate in Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=21 Participants
All participants, crossover study
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
21 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
35.6 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
Sex: Female, Male
Male
13 Participants
n=5 Participants
Region of Enrollment
United Kingdom
21 participants
n=5 Participants
Dose Provoking Fall in FEV1 of 20%
92.1 mg/ml
STANDARD_DEVIATION 113.0 • n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

The concentration of Adenosine Monophosphate (AMP), measured in mg/ml, required to see a 20% fall in the patient's forced expiratory volume in 1 second (FEV1) is measured after taking FP aerosol. AMP is a bronchoconstrictor agent (ie it narrows the airways. We would expect that more would be necessary to produce the same 20% fall in FEV1 after receiving the FP than before due to the reduction in airways inflammation. This change is the primary outcome measure.

Outcome measures

Outcome measures
Measure
Monodisperse FP 1.5um
n=21 Participants
50 mg of monodisperse Fluticasone Propionate delivered as 1.5 microns aerosol followed by AMP PC20 challenge test AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)
Monodisperse FP 6.0um
n=21 Participants
50 mg of monodisperse Fluticasone Propionate delivered as 6.0 microns aerosol followed by AMP PC20 challenge test AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)
Placebo STAG
n=21 Participants
No active drug, just solvent delivered from STAG followed by AMP PC20 challenge test AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)
MDI FP
n=21 Participants
Fluticasone Propionate , Metered dose inhaler, 250 mg dose followed by AMP PC20 challenge test AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)
AMP Challenge Test PC20
79.21 mg/ml
Standard Deviation 105.6
79.74 mg/ml
Standard Deviation 110.82
62.69 mg/ml
Standard Deviation 80.0
92.1 mg/ml
Standard Deviation 113.1

SECONDARY outcome

Timeframe: 4 hours

The concentration of Fluticasone Propionate in blood following inhalation of the dose will be measured. Cmax will be measured.

Outcome measures

Outcome measures
Measure
Monodisperse FP 1.5um
n=21 Participants
50 mg of monodisperse Fluticasone Propionate delivered as 1.5 microns aerosol followed by AMP PC20 challenge test AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)
Monodisperse FP 6.0um
n=21 Participants
50 mg of monodisperse Fluticasone Propionate delivered as 6.0 microns aerosol followed by AMP PC20 challenge test AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)
Placebo STAG
n=21 Participants
No active drug, just solvent delivered from STAG followed by AMP PC20 challenge test AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)
MDI FP
n=21 Participants
Fluticasone Propionate , Metered dose inhaler, 250 mg dose followed by AMP PC20 challenge test AMP CHALLENGE PC20: Dose Provoking Fall in FEV1 of 20% (mg/ml)
The Concentration of Fluticasone Propionate
283.4 pg/ml
Standard Deviation 388.4
636 pg/ml
Standard Deviation 397.6
0 pg/ml
Standard Deviation 0
86.94 pg/ml
Standard Deviation 47.0

SECONDARY outcome

Timeframe: 0 and 4 hours

Population: Data not collected

FEV1 and FVC will be measured before and after drug administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 and 4 hours

Population: Data not collected

At each study visit subjects will breathe in oxygen from a machine, which at the same time will measure the composition of the gases in each exhaled breath. The main gas we are interested in is nitrogen as this makes up the bulk of the air that we breathe. This test is known as the 'multi-breath nitrogen washout'. The test takes 20 minutes and we shall do this at the beginning and at the end of each study visit.

Outcome measures

Outcome data not reported

Adverse Events

Monodisperse FP 1.5um

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Monodisperse FP 6.0um

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo STAG

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MDI FP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Omar Usmani

Imperial College London

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place