AsthmaPhase 2NCT01200108
AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma
A Phase 2 study testing Budesonide in people with Asthma, run by Activaero GmbH at 24 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 24 sitesin 3 countries
- Study dates
- Mar 2010to Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
Germany10 sites
Study site
Berlin, 10717
Study site
Bonn, 53119
Study site
Bonn, 53123
Study site
Darmstadt, 64287
Peter, Kardos, MD
Frankfurt, 60318
Study site
Marburg, 35037
Study site
München, 80331
Study site
Rodgau-Dudenhofen, 63110
Study site
Rüdersdorf, 15562
Study site
Schwetzingen, 68723
Poland8 sites
Study site
Katowice, 40-752
Study site
Krakow, 31-159
Study site
Lódz, 92-215
Study site
Lublin, 20-954
Study site
Poznán, 60-214
Study site
Skierniewice, 96-100
Study site
Warsaw, 02-097
Study site
Wroclaw, 50-239
Ukraine6 sites
Study site
Dnipropetrovsk, 49074
Study site
Donetsk, 83099
Study site
Ivano-Frankivsk, 76018
Study site
Kharkiv, 61124
Study site
Kyiv, 03680
Study site
Vinnytsia, 21029
About this study
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
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.
- Conditions
- Asthma
- Being tested
- Budesonide
- Keywords
- Severe Asthma, requiring chronic oral steroid use
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
BudesonideDrug
BudesonideDrug
| Study group | Role | What they receive |
|---|---|---|
| Budesonide high dose via AKITA (1mg/2ml) | Experimental | Not described Receives: Drug: Budesonide |
| Budesonide low dose via AKITA (0.5mg/2ml) | Experimental | Not described Receives: Drug: Budesonide |
| Budesonide high dose via conventional nebulizer (1mg/2ml) | Active comparator | Not described Receives: Drug: Budesonide |
| Placebo via AKITA | No intervention | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
Sponsor and investigators
- Lead sponsor
- Activaero GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Kardos, MD, Principal investigator, Peter Kardos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200108
- Sponsor's protocol ID
- Acti-AICS-001
- Status last verified
- Nov 2011
- First submitted
- 10 Sep 2010
- Last updated
- 15 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01200108
- Acronym / sponsor ID
- Acti-AICS-001
- Conditions
- Asthma
- Keywords
- Severe Asthma, requiring chronic oral steroid use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Activaero GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Budesonide high dose via AKITA (1mg/2ml) | Experimental | Drug: Budesonide |
| Budesonide low dose via AKITA (0.5mg/2ml) | Experimental | Drug: Budesonide |
| Budesonide high dose via conventional nebulizer (1mg/2ml) | Active comparator | Drug: Budesonide |
| Placebo via AKITA | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide | Drug | Budesonide high dose via AKITA (1mg/2ml) |
| Budesonide | Drug | Budesonide low dose via AKITA (0.5mg/2ml) |
| Budesonide | Drug | Budesonide high dose via conventional nebulizer (1mg/2ml) |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2011.
- Homepage of the trial sponsorLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Kardos, MD principal investigator
Peter Kardos
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Budesonide in people with Asthma, run by Activaero GmbH at 24 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Poland, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2011.