---
title: AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma
nct_id: NCT01200108
overall_status: COMPLETED
phase: PHASE2
sponsor: Activaero GmbH
study_type: INTERVENTIONAL
primary_condition: Asthma
countries: Germany, Poland, Ukraine
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01200108.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01200108"
ct_last_update_post_date: 2011-11-15
last_seen_at: "2026-05-12T06:47:53.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT01200108](https://clinicaltrials.gov/study/NCT01200108)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Lead Sponsor:** Activaero GmbH
- **Conditions:** Asthma
- **Start Date:** 2010-03
- **Completion Date:** 2011-11
- **CT.gov Last Update:** 2011-11-15

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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)
```

## Arms

- **Budesonide high dose via AKITA (1mg/2ml)** (EXPERIMENTAL)
- **Budesonide low dose via AKITA (0.5mg/2ml)** (EXPERIMENTAL)
- **Budesonide high dose via conventional nebulizer (1mg/2ml)** (ACTIVE_COMPARATOR)
- **Placebo via AKITA** (NO_INTERVENTION)

## Interventions

- **Budesonide** (DRUG)
- **Budesonide** (DRUG)
- **Budesonide** (DRUG)

## Locations (24)

- Berlin, Germany
- Bonn, Germany
- Bonn, Germany
- Darmstadt, Germany
- Peter, Kardos, MD, Frankfurt, Germany
- Marburg, Germany
- München, Germany
- Rodgau-Dudenhofen, Germany
- Rüdersdorf, Germany
- Schwetzingen, Germany
- Katowice, Poland
- Krakow, Poland
- Lódz, Poland
- Lublin, Poland
- Poznán, Poland
- Skierniewice, Poland
- Warsaw, Poland
- Wroclaw, Poland
- Dnipropetrovsk, Ukraine
- Donetsk, Ukraine
- Ivano-Frankivsk, Ukraine
- Kharkiv, Ukraine
- Kyiv, Ukraine
- Vinnytsia, Ukraine

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|berlin||germany` — added _(2026-05-12)_
- `locations.|bonn||germany` — added _(2026-05-12)_
- `locations.|darmstadt||germany` — added _(2026-05-12)_
- `locations.peter, kardos, md|frankfurt||germany` — added _(2026-05-12)_
- `locations.|marburg||germany` — added _(2026-05-12)_
- `locations.|münchen||germany` — added _(2026-05-12)_
- `locations.|rodgau-dudenhofen||germany` — added _(2026-05-12)_
- `locations.|rüdersdorf||germany` — added _(2026-05-12)_
- `locations.|schwetzingen||germany` — added _(2026-05-12)_
- `locations.|katowice||poland` — added _(2026-05-12)_
- `locations.|krakow||poland` — added _(2026-05-12)_
- `locations.|lódz||poland` — added _(2026-05-12)_
- `locations.|lublin||poland` — added _(2026-05-12)_
- `locations.|poznán||poland` — added _(2026-05-12)_
- `locations.|skierniewice||poland` — added _(2026-05-12)_
- `locations.|warsaw||poland` — added _(2026-05-12)_
- `locations.|wroclaw||poland` — added _(2026-05-12)_
- `locations.|dnipropetrovsk||ukraine` — added _(2026-05-12)_
- `locations.|donetsk||ukraine` — added _(2026-05-12)_
- `locations.|ivano-frankivsk||ukraine` — added _(2026-05-12)_
- `locations.|kharkiv||ukraine` — added _(2026-05-12)_
- `locations.|kyiv||ukraine` — added _(2026-05-12)_
- `locations.|vinnytsia||ukraine` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01200108.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01200108*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*