AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Budesonide
Budesonide
Budesonide
Sponsored by

About this trial
This is an interventional trial for Asthma focused on measuring Severe Asthma, requiring chronic oral steroid use
Eligibility Criteria
Inclusion Criteria:
- Written informed consent prior to the performance of any study-related procedures
- Age ≥ 18 and ≤ 65 year of age Diagnosis of asthma (ATS definition, either allergic or non-allergic) for ≥ 6 months
- Asthma treated for at least 3 months with inhaled (ICS) and oral corticosteroids (OCS). Exact baseline level will be measured during the screening period by subject diary entries
- FEV1 ≥ 40% or ≤ 79% predicted at the Screening or Baseline Visit
- Documented increase of FEV1 within 15-30 minutes after the use of inhaled Salbutamol at the Screening Visit or within 2 years prior to Screening
- Mandatory usage of long-acting β-agonists
- A negative pregnancy test must be available for any women of childbearing potential at screening and, in addition, a negative urine pregnancy test must be present at randomization (prior to randomization to one of the treatment groups!)
- Women of childbearing potential must agree to use a reliable method of contraception from the screening until 4 weeks after study completion or after study drug discontinuation in case study drug treatment is stopped prematurely. - In this study, hormone-based contraceptives alone are not considered as reliable method
Exclusion Criteria:
- History of allergy or adverse experience with Budesonide
- Pregnant women or nursing mothers
- Upper respiratory tract infection within 4 weeks of Screening
- Emergency room visit for treatment of asthma exacerbation within 4 weeks of Screening
- Hospitalization for asthma within 3 months of Screening
- Use of anti-IgE, methotrexate, oral gold, Dapsone, or i.v. gamma globulin within 3 months of Screening
- Treatment with other investigational asthma treatment within 30 days prior to Screening
- Evidence of chronic lung diseases other than asthma, including but not limited to: cystic fibrosis, allergic bronchopulmonary aspergillosis (ABPA), COPD, chronic bronchitis and emphysema
- History of medication noncompliance
- History of significant medical illness or condition that in the Investigator's opinion places the subject at undue risk by participating in the study
- Past episode of anaphylaxis with severe respiratory symptoms
- Oral corticosteroid average daily dose exceeding a maximum amount
- Currently smoking or history of smoking ≥ 10 pack years
- Taking oral or i.v. corticosteroids for any disease indication other than asthma
- Abnormal lab values for chemistry tests at Screening that may indicate impaired ability to metabolize and/or excrete Budesonide (AST, ALT > 3 times upper limit of normal range, serum creatinine > 1.5 times upper limit of normal range)
Sites / Locations
- Peter, Kardos, MD
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
No Intervention
Arm Label
Budesonide high dose via AKITA (1mg/2ml)
Budesonide low dose via AKITA (0.5mg/2ml)
Budesonide high dose via conventional nebulizer (1mg/2ml)
Placebo via AKITA
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01200108
Brief Title
AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma
Official Title
A Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate Tolerability, Safety and Efficacy of AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma Requiring Chronic Oral Corticosteroid Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Activaero GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of treatment with AICS is weaning from oral corticosteroids, i.e. a reduction of the oral corticosteroid dose. An anticipated treatment benefit of AICS is a reduction of oral corticosteroid dose and stability/improvement of clinical parameters related to asthma in the targeted subject population. Ultimately, the goal is to free subjects with severe asthma from the burden of chronic oral steroid therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Severe Asthma, requiring chronic oral steroid use
7. Study Design
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Arm Title
Budesonide high dose via AKITA (1mg/2ml)
Arm Type
Experimental
Arm Title
Budesonide low dose via AKITA (0.5mg/2ml)
Arm Type
Experimental
Arm Title
Budesonide high dose via conventional nebulizer (1mg/2ml)
Arm Type
Active Comparator
Arm Title
Placebo via AKITA
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Type
Drug
Intervention Name(s)
Budesonide
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent prior to the performance of any study-related procedures
Age ≥ 18 and ≤ 65 year of age Diagnosis of asthma (ATS definition, either allergic or non-allergic) for ≥ 6 months
Asthma treated for at least 3 months with inhaled (ICS) and oral corticosteroids (OCS). Exact baseline level will be measured during the screening period by subject diary entries
FEV1 ≥ 40% or ≤ 79% predicted at the Screening or Baseline Visit
Documented increase of FEV1 within 15-30 minutes after the use of inhaled Salbutamol at the Screening Visit or within 2 years prior to Screening
Mandatory usage of long-acting β-agonists
A negative pregnancy test must be available for any women of childbearing potential at screening and, in addition, a negative urine pregnancy test must be present at randomization (prior to randomization to one of the treatment groups!)
Women of childbearing potential must agree to use a reliable method of contraception from the screening until 4 weeks after study completion or after study drug discontinuation in case study drug treatment is stopped prematurely. - In this study, hormone-based contraceptives alone are not considered as reliable method
Exclusion Criteria:
History of allergy or adverse experience with Budesonide
Pregnant women or nursing mothers
Upper respiratory tract infection within 4 weeks of Screening
Emergency room visit for treatment of asthma exacerbation within 4 weeks of Screening
Hospitalization for asthma within 3 months of Screening
Use of anti-IgE, methotrexate, oral gold, Dapsone, or i.v. gamma globulin within 3 months of Screening
Treatment with other investigational asthma treatment within 30 days prior to Screening
Evidence of chronic lung diseases other than asthma, including but not limited to: cystic fibrosis, allergic bronchopulmonary aspergillosis (ABPA), COPD, chronic bronchitis and emphysema
History of medication noncompliance
History of significant medical illness or condition that in the Investigator's opinion places the subject at undue risk by participating in the study
Past episode of anaphylaxis with severe respiratory symptoms
Oral corticosteroid average daily dose exceeding a maximum amount
Currently smoking or history of smoking ≥ 10 pack years
Taking oral or i.v. corticosteroids for any disease indication other than asthma
Abnormal lab values for chemistry tests at Screening that may indicate impaired ability to metabolize and/or excrete Budesonide (AST, ALT > 3 times upper limit of normal range, serum creatinine > 1.5 times upper limit of normal range)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Kardos, MD
Organizational Affiliation
Peter Kardos
Official's Role
Principal Investigator
Facility Information:
City
Berlin
ZIP/Postal Code
10717
Country
Germany
City
Bonn
ZIP/Postal Code
53119
Country
Germany
City
Bonn
ZIP/Postal Code
53123
Country
Germany
City
Darmstadt
ZIP/Postal Code
64287
Country
Germany
Facility Name
Peter, Kardos, MD
City
Frankfurt
ZIP/Postal Code
60318
Country
Germany
City
Marburg
ZIP/Postal Code
35037
Country
Germany
City
München
ZIP/Postal Code
80331
Country
Germany
City
Rodgau-Dudenhofen
ZIP/Postal Code
63110
Country
Germany
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
City
Schwetzingen
ZIP/Postal Code
68723
Country
Germany
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
City
Kraków
ZIP/Postal Code
31-159
Country
Poland
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
City
Lódz
ZIP/Postal Code
92-215
Country
Poland
City
Poznán
ZIP/Postal Code
60-214
Country
Poland
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-239
Country
Poland
City
Dnipropetrovsk
ZIP/Postal Code
49074
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83099
Country
Ukraine
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
12. IPD Sharing Statement
Links:
URL
http://www.activaero.de
Description
Homepage of the trial sponsor
Learn more about this trial
AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma
We'll reach out to this number within 24 hrs