Clinical Trial Results:
The RECONSTRUCT study
Reconstructing Disease Mechanisms in Asthma
Summary
|
|
EudraCT number |
2016-003509-33 |
Trial protocol |
DK |
Global end of trial date |
01 Apr 2019
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
02 Apr 2021
|
First version publication date |
02 Apr 2021
|
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 |
RECONSTRUCT
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Lungemedicinsk Forskningsenhed, Bispebjerg Hospital
|
||
Sponsor organisation address |
Bispebjerg bakke 23, indgang 66, København NV, Denmark, 2400
|
||
Public contact |
Lungemedicinsk Forskningsenhed, Lungemedicinsk Forskningsenhed, Bispebjerg Hospital, +45 60770127, morten.hvidtfeldt@regionh.dk
|
||
Scientific contact |
Lungemedicinsk Forskningsenhed, Lungemedicinsk Forskningsenhed, Bispebjerg Hospital, +45 60770127, morten.hvidtfeldt@regionh.dk
|
||
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 |
17 Mar 2021
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
01 Apr 2019
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
01 Apr 2019
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To describe the correlation between increase in ASM content of Na+, K+ pumps and reduction in airway hyperresponsiveness to mannitol after six weeks of daily inhalation of glucocorticoid, in patients with asthma and to describe differences in ASM content of Na+, K+ pumps among healthy subjects and patients with non-eosinophilic asthma (NEA) or eosinophilic asthma (EA) respectively.
Primary endpoint:
|
||
Protection of trial subjects |
Trial subjects were monitored closely once weekly by phone
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Mar 2017
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Denmark: 60
|
||
Worldwide total number of subjects |
60
|
||
EEA total number of subjects |
60
|
||
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) |
60
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
||||||||||||||||
Recruitment
|
||||||||||||||||
Recruitment details |
Patients were recruited continuously | |||||||||||||||
Pre-assignment
|
||||||||||||||||
Screening details |
Non-smoking patients with asthma and airway hyperresponsiveness to mannitol not currently on inhaled corticosteroids. | |||||||||||||||
Period 1
|
||||||||||||||||
Period 1 title |
Intervention
|
|||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Not applicable
|
|||||||||||||||
Blinding used |
Not blinded | |||||||||||||||
Arms
|
||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||
Arm title
|
Type 2 high asthma | |||||||||||||||
Arm description |
Type 2 high asthma based on FeNO > 25 ppb | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Budesonide
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
Spirocort
|
|||||||||||||||
Pharmaceutical forms |
Inhalation powder, pre-dispensed
|
|||||||||||||||
Routes of administration |
Inhalation use
|
|||||||||||||||
Dosage and administration details |
1600 ug daily
|
|||||||||||||||
Arm title
|
Type 2 low asthma | |||||||||||||||
Arm description |
Type 2 low asthma based on FeNO < 25 ppb | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Budesonide
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
Spirocort
|
|||||||||||||||
Pharmaceutical forms |
Inhalation powder, pre-dispensed
|
|||||||||||||||
Routes of administration |
Inhalation use
|
|||||||||||||||
Dosage and administration details |
1600 ug daily
|
|||||||||||||||
|
||||||||||||||||
Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: - |
||||||||||||||||
Period 2
|
||||||||||||||||
Period 2 title |
Healthy controls
|
|||||||||||||||
Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Not applicable
|
|||||||||||||||
Blinding used |
Not blinded | |||||||||||||||
Arms
|
||||||||||||||||
Arm title
|
Healthy controls | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
No intervention | |||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
|
|||||||||||||||
|
||||||||||||||||
Notes [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: - |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Intervention
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis sets
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Type 2 high asthma
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Type 2 high asthma with FeNO>25 ppb at baseline
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Type 2 low asthma
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Type 2 low asthma with FeNO<25 ppb at baseline
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Type 2 high asthma
|
||
Reporting group description |
Type 2 high asthma based on FeNO > 25 ppb | ||
Reporting group title |
Type 2 low asthma
|
||
Reporting group description |
Type 2 low asthma based on FeNO < 25 ppb | ||
Reporting group title |
Healthy controls
|
||
Reporting group description |
- | ||
Subject analysis set title |
Type 2 high asthma
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Type 2 high asthma with FeNO>25 ppb at baseline
|
||
Subject analysis set title |
Type 2 low asthma
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Type 2 low asthma with FeNO<25 ppb at baseline
|
|
|||||||||||||||||||||
End point title |
Airway hyperresponsiveness | ||||||||||||||||||||
End point description |
Doubling dose of PD15 to mannitol
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Before and after intervention
|
||||||||||||||||||||
|
|||||||||||||||||||||
Statistical analysis title |
Difference in change in AHR | ||||||||||||||||||||
Comparison groups |
Type 2 high asthma v Type 2 low asthma
|
||||||||||||||||||||
Number of subjects included in analysis |
46
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
equivalence | ||||||||||||||||||||
P-value |
= 0.92 | ||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||
Confidence interval |
|
|||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||
Timeframe for reporting adverse events |
During study period
|
||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||
Dictionary version |
19
|
||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||
Reporting group title |
All patients
|
||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||
|
|||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
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 |