AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma

November 14, 2011 updated by: Activaero GmbH

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10717
      • Bonn, Germany, 53119
      • Bonn, Germany, 53123
      • Darmstadt, Germany, 64287
      • Frankfurt, Germany, 60318
        • Peter, Kardos, MD
      • Marburg, Germany, 35037
      • München, Germany, 80331
      • Rodgau-Dudenhofen, Germany, 63110
      • Rüdersdorf, Germany, 15562
      • Schwetzingen, Germany, 68723
  • Poland
      • Katowice, Poland, 40-752
      • Kraków, Poland, 31-159
      • Lublin, Poland, 20-954
      • Lódz, Poland, 92-215
      • Poznán, Poland, 60-214
      • Skierniewice, Poland, 96-100
      • Warszawa, Poland, 02-097
      • Wroclaw, Poland, 50-239
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49074
      • Donetsk, Ukraine, 83099
      • Ivano-Frankivsk, Ukraine, 76018
      • Kharkiv, Ukraine, 61124
      • Kyiv, Ukraine, 03680
      • Vinnytsia, Ukraine, 21029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Budesonide high dose via AKITA (1mg/2ml)
Drug: Budesonide
Experimental: Budesonide low dose via AKITA (0.5mg/2ml)
Drug: Budesonide
Active Comparator: Budesonide high dose via conventional nebulizer (1mg/2ml)
Drug: Budesonide
No Intervention: Placebo via AKITA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Activaero GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Kardos, MD, Peter Kardos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Acti-AICS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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