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

This study has been completed.
Sponsor:
Information provided by:
Activaero GmbH
ClinicalTrials.gov Identifier:
NCT01200108
First received: September 10, 2010
Last updated: November 14, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Budesonide
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Activaero GmbH:

Study Start Date: March 2010
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200108

Locations
Germany
Berlin, Germany, 10717
Bonn, Germany, 53119
Bonn, Germany, 53123
Darmstadt, Germany, 64287
Peter, Kardos, MD
Frankfurt, Germany, 60318
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
Sponsors and Collaborators
Activaero GmbH
Investigators
Principal Investigator: Peter Kardos, MD Peter Kardos
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Thomas Hofmann, Activaero GmbH
ClinicalTrials.gov Identifier: NCT01200108     History of Changes
Other Study ID Numbers: Acti-AICS-001
Study First Received: September 10, 2010
Last Updated: November 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Activaero GmbH:
Severe Asthma, requiring chronic oral steroid use

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 16, 2014