Asthma Clinical Trial
Official title:
Comparison of Ciclesonide (80 mcg or 160 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients
| Verified date | October 2016 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
| Status | Completed |
| Enrollment | 750 |
| Est. completion date | November 2005 |
| Est. primary completion date | November 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years to 11 Years |
| Eligibility |
Main Inclusion Criteria: - History of persistent bronchial asthma for at least 6 months - FEV1 50-90% of predicted Main Exclusion Criteria: - Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids - COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function - Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study - History of life-threatening asthma - Premature birth - Current smoking - Smoking history with either equal or more than 10 pack-years - Pregnancy - Intention to become pregnant during the course of the study - Breast feeding - Lack of safe contraception |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Altana Pharma/Nycomed | Campinas - SP | |
| Brazil | Altana Pharma/Nycomed | Curitiba-PR | |
| Brazil | Altana Pharma/Nycomed | Florianópolis-SC | |
| Brazil | Altana Pharma/Nycomed | Porto Alegre-RS | |
| Brazil | Altana Pharma/Nycomed | Porto Alegre-RS | |
| Brazil | Altana Pharma/Nycomed | Rio de Janeiro-RJ | |
| Brazil | Altana Pharma/Nycomed | Salvador - Bahia | |
| Brazil | Altana Pharma/Nycomed | Santo André-SP | |
| Brazil | Altana Pharma/Nycomed | Sao Paulo - SP | |
| Brazil | Altana Pharma/Nycomed | Sao Paulo-SP | |
| Brazil | Altana Pharma/Nycomed | São Paulo-SP | |
| Brazil | Altana Pharma/Nycomed | São Paulo-SP | |
| Germany | Altana Pharma/Nycomed | Frankfurt | |
| Germany | Altana Pharma/Nycomed | Gaißach bei Bad Tölz | |
| Germany | Altana Pharma/Nycomed | Geesthacht | |
| Germany | Altana Pharma/Nycomed | Mainz | |
| Germany | Altana Pharma/Nycomed | München | |
| Germany | Altana Pharma/Nycomed | München | |
| Germany | Altana Pharma/Nycomed | Wesel | |
| Germany | Altana Pharma/Nycomed | Wiefelstede | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Debrecen | |
| Hungary | Altana Pharma/Nycomed | Jaszbereny | |
| Hungary | Altana Pharma/Nycomed | Miskolc | |
| Hungary | Altana Pharma/Nycomed | Mosdos | |
| Hungary | Altana Pharma/Nycomed | Pecs | |
| Hungary | Altana Pharma/Nycomed | Törökbalint | |
| Poland | Altana Pharma/Nycomed | Inowroclaw | |
| Poland | Altana Pharma/Nycomed | Lodz | |
| Poland | Altana Pharma/Nycomed | Lublin | |
| Poland | Altana Pharma/Nycomed | Poznan | |
| Poland | Altana Pharma/Nycomed | Rzeszow | |
| Poland | Altana Pharma/Nycomed | Warszawa | |
| Poland | Altana Pharma/Nycomed | Warszawa | |
| Poland | Altana Pharma/Nycomed | Zawadzkie | |
| Portugal | Altana Pharma/Nycomed | Amadora | |
| Portugal | Altana Pharma/Nycomed | Faro | |
| Portugal | Altana Pharma/Nycomed | Guimaraes | |
| Portugal | Altana Pharma/Nycomed | Lisboa | |
| Portugal | Altana Pharma/Nycomed | Lisboa | |
| Portugal | Altana Pharma/Nycomed | Lisboa | |
| Portugal | Altana Pharma/Nycomed | Matosinhos | |
| Portugal | Altana Pharma/Nycomed | Oliveira de Azemeis | |
| Portugal | Altana Pharma/Nycomed | Porto | |
| Portugal | Altana Pharma/Nycomed | Porto | |
| Portugal | Altana Pharma/Nycomed | Setúbal | |
| Portugal | Altana Pharma/Nycomed | Viana do Castelo | |
| Portugal | Altana Pharma/Nycomed | Vila Nova de Gaia | |
| South Africa | Altana Pharma/Nycomed | Bellville - Cape Town - | |
| South Africa | Altana Pharma/Nycomed | Cape Town | |
| South Africa | Altana Pharma/Nycomed | Morningside, Sandton | |
| South Africa | Altana Pharma/Nycomed | Mowbray, Cape Town | |
| South Africa | Altana Pharma/Nycomed | Panorama / RSA-Cape Town | |
| South Africa | Altana Pharma/Nycomed | Westville | |
| South Africa | Altana Pharma/Nycomed | Wynberg |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Brazil, Germany, Hungary, Poland, Portugal, South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | FEV1 absolute values | |||
| Primary | PD20FEV1 from methacholine challenge. | |||
| Secondary | FEV1 as % of predicted | |||
| Secondary | PEF from spirometry | |||
| Secondary | morning and evening PEF from diary | |||
| Secondary | asthma symptom score from diary | |||
| Secondary | salbutamol MDI use from diary | |||
| Secondary | diurnal PEF fluctuation from diary | |||
| Secondary | dropout rate due to asthma exacerbations and time to the first asthma exacerbation | |||
| Secondary | percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control | |||
| Secondary | onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication | |||
| Secondary | interview administered PAQLQ(S), self-administered PACQLQ | |||
| Secondary | physical examination and vital signs | |||
| Secondary | laboratory investigation | |||
| Secondary | AEs | |||
| Secondary | HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
| Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
| Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
| Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
| Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
| Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
| Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
| Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
| Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
| Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
| Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
| Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
| Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
| Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
| Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
| Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
| Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
| Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|