Clinical Trial Results:
A randomised, open, controlled pilot study to investigate the potential of Buparid/PARI SINUS versus Budes® Nasal Spray to avoid or postpone sinus surgery in adult patients with Chronic Rhinosinusitis (CRS)
|
Summary
|
|
EudraCT number |
2013-002421-30 |
Trial protocol |
DE |
Global end of trial date |
29 Jul 2021
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
11 Sep 2021
|
First version publication date |
11 Sep 2021
|
Other versions |
|
Summary report(s) |
Study Synopsis |
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 |
12082.102
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
PARI Pharma GmbH
|
||
Sponsor organisation address |
Lochhamer Schlag 21, Gräfelfing, Germany, 82166
|
||
Public contact |
Clinical Trial Manager, PARI Pharma GmbH, 49 8974284676, friedrich.gruber@pari.com
|
||
Scientific contact |
Clinical Trial Manager, PARI Pharma GmbH, 49 8974284676, friedrich.gruber@pari.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 |
03 Feb 2020
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
29 Jul 2021
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
The objective of this study is to analyse whether Buparid/PARI SINUS has a higher potential to avoid or postpone sinus surgery in adult patients with CRS than Standard of Care therapy with Budes® Nasal Spray. The results of this study are expected to provide estimates for a proper sample size calculation to conduct
a pivotal study.
|
||
Protection of trial subjects |
Special caution is necessary in patients with active or quiescent pulmonary tuberculosis and in patients with fungal or viral infections in the airways.
During transfer from oral therapy to Buparid, a generally lower systemic corticosteroid action will be experienced, which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain. Specific treatment should be initiated for these conditions. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.
Patients, who have required high dose emergency corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk of impaired adrenal function. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid treatment should be considered during periods of stress or elective surgery.
Systemic effects may occur with any inhaled corticosteroids, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Oral candidiasis may occur during the therapy with inhaled corticosteroids. This infection may require treatment with appropriate antifungal therapy and in some patients discontinuation of treatment may be necessary.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Apr 2014
|
||
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 |
Germany: 19
|
||
Worldwide total number of subjects |
19
|
||
EEA total number of subjects |
19
|
||
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) |
19
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
||||||||||
|
Recruitment
|
||||||||||
Recruitment details |
Enrolment period 33 months 3 clinical centres in Germany participated in the trial | |||||||||
|
Pre-assignment
|
||||||||||
Screening details |
Diagnosis and main criteria for inclusion: Patient with confirmed diagnosis of chronic rhinosinusitis (CRS), i.e. inflammation of nasal mucosa and paranasal sinus. Diagnosis is based on history of symptoms (nasal obstruction, running nose, postnasal drip, facial pain and hyposmia with a duration of > 3 months and on MRT imaging. | |||||||||
|
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 |
n.a.
|
|||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH) | |||||||||
Arm description |
Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: Budesonide | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: Budesonide
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Nebuliser suspension
|
|||||||||
Routes of administration |
Intranasal use
|
|||||||||
Dosage and administration details |
In patients allocated to receive Buparid, the drug will be administered by a once daily inhala-tion (in the evening) using the PARI SINUS nebuliser. At every study visit, one inhalation cycle will be monitored by the clinical trial centre personnel.
|
|||||||||
|
Arm title
|
Budes® Nasal Spray 50 µg/pump (Hexal AG) | |||||||||
Arm description |
Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Nasal spray
|
|||||||||
Routes of administration |
Intranasal use
|
|||||||||
Dosage and administration details |
In patients allocated to receive Budes Nasal Spray, the drug will be administered with 2 pumps per nostril twice daily (in the morning and the evening).
|
|||||||||
|
||||||||||
|
|||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH)
|
||
Reporting group description |
Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: Budesonide | ||
Reporting group title |
Budes® Nasal Spray 50 µg/pump (Hexal AG)
|
||
Reporting group description |
Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide | ||
|
|||||||||||||
End point title |
Nasal obstruction | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Visits 1 to 4
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Rhinomanometry | ||||||||||||
Comparison groups |
Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH) v Budes® Nasal Spray 50 µg/pump (Hexal AG)
|
||||||||||||
Number of subjects included in analysis |
19
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
> 0.95 | ||||||||||||
Method |
MMRM | ||||||||||||
Confidence interval |
|||||||||||||
|
|||||||||||||
End point title |
Health specific quality of life | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Visits 1 to 6
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
SNOT-20 | ||||||||||||
Comparison groups |
Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH) v Budes® Nasal Spray 50 µg/pump (Hexal AG)
|
||||||||||||
Number of subjects included in analysis |
19
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
other | ||||||||||||
P-value |
> 0.001 | ||||||||||||
Method |
MMRM | ||||||||||||
Confidence interval |
|||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
from FPI until LPO
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Arm 1 Buparid Sinus
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Arm 2 Budes Nasal Spray
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
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 | |||
