Ignite Creation Date:
2024-05-06 @ 3:11 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02227394
Status:
COMPLETED
Last Update Posted:
2022-01-27
First Post:
2014-08-25
Brief Title:
Study to Compare the Effects of Z7200 And Symbicort Turbohaler on Respiratory Imaging Parameters in Asthmatic Patients
Sponsor:
Zambon SpA
Organization:
Zambon SpA
Study Overview
Official Title:
A Double Blind Double Dummy Randomized Two Way Cross-over Study to Compare the Effects of Z7200 and Symbicort Turbohaler on Functional Respiratory Imaging Parameters in Asthmatic Patients
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective
The primary objective of this study is to evaluate the effect of the products under investigation on functional respiratory imaging parameters and evaluate the particle deposition with Computational fluid dynamics CFD
Secondary Objectives
The secondary objectives of this study were to assess the effect of test product and reference product on
lung function spirometry and body plethysmography
exercise capacity 6-Minute Walking Test 6MWT or equivalent method to measure exercise tolerance
dyspnea Borg Category C Ratio R 10 Borg CR10 scale and Visual Analogue Scale VAS dyspnea
Furthermore the safety of the test product and reference product was evaluated through monitoring of AEs throughout the study
The primary objective of this study is to evaluate the effect of the products under investigation on functional respiratory imaging parameters and evaluate the particle deposition with Computational fluid dynamics CFD
Secondary Objectives
The secondary objectives of this study were to assess the effect of test product and reference product on
lung function spirometry and body plethysmography
exercise capacity 6-Minute Walking Test 6MWT or equivalent method to measure exercise tolerance
dyspnea Borg Category C Ratio R 10 Borg CR10 scale and Visual Analogue Scale VAS dyspnea
Furthermore the safety of the test product and reference product was evaluated through monitoring of AEs throughout the study
Detailed Description:
This study is conducted as a randomized double blind double dummy two-period crossover study in stable asthma patients treated in accordance with the Global Initiative for Asthma GINA guidelines
On the first dosing day Period 1 Visit 2 asthma stability was assessed based on review of pharmacologic treatment monitoring and FEV1 change from the previous visit Patients were then randomized and allocated to one of two treatment sequences ie testreference or referencetest Randomization codes were assigned strictly sequentially as patients became eligible for randomization Patients received a single dose consisting of two inhalations of either the test product or the reference product according to the assigned treatment sequence in the presence of the Investigator or authorized site personnel In addition patients received two inhalations with matching placebo to the alternate treatment as a dummy inhaler to achieve double-blinding All patients followed the same sequence of device inhalation ie Symbicort or placebo Turbohaler first and Z7200 or placebo RS-01 inhaler second
On the second dosing day Period 2 Visit 3 patients underwent the same asthma stability check and procedures as in Visit 2 Patients received a single dose consisting of two inhalations of the other treatment reference in case test product was administered at Visit 2 and vice versa plus two inhalations with matching placebo to the alternate treatment
On the first dosing day Period 1 Visit 2 asthma stability was assessed based on review of pharmacologic treatment monitoring and FEV1 change from the previous visit Patients were then randomized and allocated to one of two treatment sequences ie testreference or referencetest Randomization codes were assigned strictly sequentially as patients became eligible for randomization Patients received a single dose consisting of two inhalations of either the test product or the reference product according to the assigned treatment sequence in the presence of the Investigator or authorized site personnel In addition patients received two inhalations with matching placebo to the alternate treatment as a dummy inhaler to achieve double-blinding All patients followed the same sequence of device inhalation ie Symbicort or placebo Turbohaler first and Z7200 or placebo RS-01 inhaler second
On the second dosing day Period 2 Visit 3 patients underwent the same asthma stability check and procedures as in Visit 2 Patients received a single dose consisting of two inhalations of the other treatment reference in case test product was administered at Visit 2 and vice versa plus two inhalations with matching placebo to the alternate treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-002151-26 | EUDRACT_NUMBER | None | None |