Clinical Trial Results:
Use of Buventol Easyhaler and Bufomix Easyhaler as Relievers in Methacholine Challenge Testing and Inspiratory Flow Profiles during Induced Bronchoconstriction in Adult Subjects
|
Summary
|
|
EudraCT number |
2021-001573-22 |
Trial protocol |
FI |
Global end of trial date |
30 Jun 2023
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
08 Jun 2024
|
First version publication date |
08 Jun 2024
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
0010032
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT05084222 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Orion Corporation
|
||
Sponsor organisation address |
Orionintie 1, Espoo, Finland, 02100
|
||
Public contact |
Clinical Trial Information Desk, Orion Corporation, +358 104261, clinicaltrials@orionpharma.com
|
||
Scientific contact |
Clinical Trial Information Desk, Orion Corporation, +358 104261, clinicaltrials@orionpharma.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
30 Jun 2023
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
30 Jun 2023
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
30 Jun 2023
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To show non-inferiority of Buventol Easyhaler to Ventoline Evohaler in treatment of induced bronchoconstriction
|
||
Protection of trial subjects |
The participants were monitored by the site personnel during the whole study. All study treatments were administered at the study site under the supervision of the site personnel. Additional salbutamol was administered in case bronchoconstriction did not recover at the specified time frame. If the participant still did not reach the desired level of FEV1, a physician was called upon, and, if needed, the participant was treated on clinical grounds. Adequate medical expertise and facilities to handle possible emergency situations were available during the study.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Nov 2021
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Finland: 180
|
||
Worldwide total number of subjects |
180
|
||
EEA total number of subjects |
180
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
151
|
||
From 65 to 84 years |
29
|
||
85 years and over |
0
|
||
|
|||||||||||||
|
Recruitment
|
|||||||||||||
Recruitment details |
A total of 601 adult subjects were screened and 180 were randomised to the study in two study sites in Finland. | ||||||||||||
|
Pre-assignment
|
|||||||||||||
Screening details |
The methacholine challenge testing was performed and participants who experienced forced expired volume in 1 second (FEV1) drop ≥ 20% compared to post-diluent spirometry were included. | ||||||||||||
|
Period 1
|
|||||||||||||
Period 1 title |
Overall trial (overall period)
|
||||||||||||
Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||
Blinding used |
Not blinded | ||||||||||||
Blinding implementation details |
NA, open label study.
|
||||||||||||
|
Arms
|
|||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||
|
Arm title
|
Bufomix Easyhaler | ||||||||||||
Arm description |
Two inhalations were administered from Bufomix Easyhaler 160/4.5 µg resulting in dose of 320/9 µg of budesonide and formoterol, respectively. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
budesonide and formoterol fumarate dihydrate
|
||||||||||||
Investigational medicinal product code |
|||||||||||||
Other name |
|||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||
Dosage and administration details |
Two inhalations were administered from Bufomix Easyhaler 160/4.5 µg resulting in dose of 320/9 µg of budesonide and formoterol, respectively. The dose was repeated once if needed.
|
||||||||||||
|
Arm title
|
Buventol Easyhaler | ||||||||||||
Arm description |
400 µg of salbutamol from Buventol Easyhaler was administered as two 200 µg inhalations. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
salbutamol sulfate
|
||||||||||||
Investigational medicinal product code |
|||||||||||||
Other name |
|||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||
Dosage and administration details |
400 µg of salbutamol from Buventol Easyhaler was administered as two 200 µg inhalations. The dose was repeated once if needed.
|
||||||||||||
|
Arm title
|
Ventoline Evohaler | ||||||||||||
Arm description |
400 µg of salbutamol from Ventoline Evohaler was administered via Volumatic spacer. | ||||||||||||
Arm type |
Active comparator | ||||||||||||
Investigational medicinal product name |
salbutamol sulfate
|
||||||||||||
Investigational medicinal product code |
|||||||||||||
Other name |
|||||||||||||
Pharmaceutical forms |
Pressurised inhalation
|
||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||
Dosage and administration details |
400 µg of salbutamol from Ventoline Evohaler was administered via Volumatic spacer. A single dose was administered to the spacer and the participant inhaled it before the next dose. This resulted in 4 cycles of administration. The dose was repeated once if needed.
|
||||||||||||
|
|||||||||||||
|
|||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||
Reporting group title |
Overall trial
|
||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Bufomix Easyhaler
|
||
Reporting group description |
Two inhalations were administered from Bufomix Easyhaler 160/4.5 µg resulting in dose of 320/9 µg of budesonide and formoterol, respectively. | ||
Reporting group title |
Buventol Easyhaler
|
||
Reporting group description |
400 µg of salbutamol from Buventol Easyhaler was administered as two 200 µg inhalations. | ||
Reporting group title |
Ventoline Evohaler
|
||
Reporting group description |
400 µg of salbutamol from Ventoline Evohaler was administered via Volumatic spacer. | ||
|
|||||||||||||||||
End point title |
FEV1 | ||||||||||||||||
End point description |
Mean change in forced expired volume in 1 second (FEV1) from post-diluent to FEV1 after the first study treatment dose.
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
FEV1 was measured 10 minutes after study treatment dosing.
|
||||||||||||||||
|
|||||||||||||||||
Statistical analysis title |
FEV1 after treatment, change from baseline | ||||||||||||||||
Statistical analysis description |
analysis of covariance between Buventol Easyhaler and Ventoline Evohaler
|
||||||||||||||||
Comparison groups |
Buventol Easyhaler v Ventoline Evohaler
|
||||||||||||||||
Number of subjects included in analysis |
120
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
non-inferiority | ||||||||||||||||
Method |
|||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Point estimate |
-0.083
|
||||||||||||||||
Confidence interval |
|||||||||||||||||
level |
95% | ||||||||||||||||
sides |
1-sided
|
||||||||||||||||
lower limit |
-0.146 | ||||||||||||||||
upper limit |
- | ||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse events were collected during the whole study.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Bufomix Easyhaler
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Two inhalations were administered from Bufomix Easyhaler 160/4.5 µg resulting in dose of 320/9 µg of budesonide and formoterol, respectively. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Buventol Easyhaler
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
400 µg of salbutamol from Buventol Easyhaler was administered as two 200 µg inhalations. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ventoline Evohaler
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
400 µg of salbutamol from Ventoline Evohaler was administered via Volumatic spacer. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
12 Jan 2023 |
Another study site was added.
Collection of concomitant treatments for AEs before and during MC test was added.
Collection of age was added.
Recording of smoking status was added as it was missing from the original protocol by
mistake. Smoking status is important information to characterise the patients. |
||
22 May 2023 |
Recording of spirometric inspiratory values (PIF and inspiratory volume) from already performed spirometries to develop a statistical prediction model to estimate PIF via Easyhaler was added. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
