Phase 2
Completed N=20
Study to Compare the Effects of Z7200 And Symbicort® Turbohaler on Respiratory Imaging Parameters in Asthmatic Patients
Asthma · Asthma Chronic · Asthma Bronchial · Asthmatic
Source: ClinicalTrials.gov NCT02227394 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Total Airway Volume (iVaw) — 49.033; 48.577; 51.101; 50.831 mL — p=0.727
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Airway Volume (iVaw) |
49.033; 48.577; 51.101; 50.831; 2.068; 2.255 | 0.727 |
| PRIMARY Total Airway Resistance (iRaw) |
0.034; 0.037; 0.025; 0.026; -0.008; -0.011 | 0.366 |
| PRIMARY Number of Deposited Particles Per Pre-defined Airway Section |
776339324; 17306552; 80448811; 425671 | — |
| SECONDARY Spirometry - FEV1 |
2.935; 2.905; 3.112; 3.058; 0.178; 0.153 | 0.486 |
| SECONDARY Spirometry - FVC |
4.317; 4.311; 4.384; 4.328; 0.066; 0.018 | 0.413 |
| SECONDARY Spirometry - PEF |
7.593; 7.465; 7.912; 7.883; 0.319; 0.419 | 0.375 |
| SECONDARY Spirometry - MEF25 |
0.700; 0.653; 0.873; 0.818; 0.173; 0.164 | 0.879 |
| SECONDARY Spirometry - MEF50 |
2.439; 2.350; 2.878; 2.767; 0.440; 0.416 | 0.819 |
| SECONDARY Spirometry - FEV1/FVC Ratio |
67.200; 66.800; 70.600; 70.600; 3.400; 3.800 | 0.643 |
| SECONDARY Body Plethysmography - FRC |
3.661; 3.685; 3.485; 3.498; -0.176; -0.187 | 0.866 |
| SECONDARY Body Plethysmography - TLC |
7.003; 7.008; 7.007; 6.957; 0.004; -0.051 | 0.346 |
| SECONDARY Body Plethysmography - Raw |
0.398; 0.411; 0.292; 0.276; -0.106; -0.135 | 0.093 |
| SECONDARY Body Plethysmography - SRaw |
1.656; 1.668; 1.137; 1.223; -0.519; -0.445 | 0.686 |
| SECONDARY Inhalation Profile |
2.565; 2.366 | — |
| SECONDARY 6MWT |
577.789; 583.789; 581.789; 598.158; 4.000; 14.368 | 0.312 |
| SECONDARY Borg CR10 Scale (Pre-6MWT) |
0.805; 0.670; 0.935; 0.820; 0.130; 0.150 | 0.920 |
| SECONDARY Borg CR10 Scale (Post-6MWT) |
1.945; 1.580; 1.820; 1.375; -0.125; -0.205 | 0.818 |
| SECONDARY VAS (Pre-6MWT) |
19.550; 8.150 | 0.034 sig |
| SECONDARY VAS (Post-6MWT) |
21.450; 15.850 | 0.427 |
Eligibility Criteria
Inclusion Criteria
- Male or female patient ≥ 18 years old.
- Written informed consent obtained.
- Patient with a documented diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines
- Patient with a co-operative attitude and ability to correctly use the DPI.
- Female patient of childbearing potential who confirm that a reliable method of contraception was used at least 14 days before visit 1 and will continue to use a reliable method of contraception during the study, or post-menopausal women (at least 12 months of amenorrhea)
- Patient must be stable and treated in accordance with the GINA guidelines.
- Patient must be a non-smoker or ex-smoker who have stopped smoking at least 1 month prior to visit 1 and has a smoking history of < 10 pack years.
- Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.
Exclusion Criteria
- Pregnant or lactating female.
- Unstable patient who developed an asthma exacerbation in the 4 weeks before screening.
- Patient with upper or lower airways infection in the 4 weeks before screening.
- Patient unable to perform pulmonary function testing.
- Patients unable to withdraw fixed combination or long acting bronchodilator inhalation products
- Patient with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
- Patient with active lung cancer or any other chronic disease with poor prognosis and /or affecting patient status.
- Patient with allergy, sensitivity or intolerance to study drugs and/ or study drug formulation ingredients.
- Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
- Patient who received systemic corticosteroids within the last 4 weeks prior to visit
- Patient who received any investigational new drug within the last 4 weeks prior to visit 1 and is participating in any clinical trial.
- Patient with a history of alcohol or substance abuse that in the opinion of the investigator may be of clinical significance
- Patient with diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
- Patients who has a lactose intolerance or history of allergy to milk proteins.
- Patients treated with medications or herbal medicines that are strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, indinavir, nelfinavir, saquinavir, atazanavir, ketoconazole, itraconazole, voriconazole, fluconazole, cyclosporine, mibefradil, nefazodone, clarithromycin, telithromycin, troleandromycin, norfloxacin, ciprofloxacin) or inducers (e.g. phenobarbital, phenytoin, barbiturates, carbamazepine, oxcarbazepine, rifabutin, rifampin, St John's wort) within 2 weeks prior to Screening Visit and during the study.
Data sourced from ClinicalTrials.gov (NCT02227394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.