A Study to Assess the Efficacy of Inhaled Corticosteroid (ICS) Therapy in Moderate-Severe Bronchial Asthma

NCT00411567 | Completed Phase 1

• 1 other identifier: CQAE397A2202
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate/assess the treatment of moderate to severe asthmatics with inhaled corticosteroid.

Conditions

Bronchial Asthma

Keywords

markers, inflammation, optimal, sub-optimal, corticosteroid, bronchial asthma

Outcome Measures

Primary Outcomes (1)

• Change in inflammatory parameters in response to a decrease in ICS compared to no change in therapy after 2 and 4 weeks

Secondary Outcomes (2)

• Parameter/combination of parameters most sensitive to the ICS reduction

• Collection of relative data to assess sample size calculations for subsequent studies

Interventions

inhaled corticosteroid therapy DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and/or female moderate to severe asthmatic patients, from 18-75 years of age.
• Moderate to severe asthma, according to the GINA guidelines, for at least one year with no exacerbations requiring hospitalization and/or oral steroids within the previous three months.
• No concomitant lung disease or significant medical conditions
• Fluticasone propionate 500mcg daily or greater, or equivalent (Mometsaone 800 mcg, triamcinolone 2000 mcg, Flunisolide 2000 mcg, Budesonide DPI 800 mcg, Beclomathasone HFA 500 mcg, Beclomethasone CFC 1000 mcg, Forced expiratory volume in 1 second (FEV1) at screening will be ≥ 70% of the normal predicted.
• Evidence of asthma, demonstrated by one of the following: Historical evidence confirmed by their treating physician or Demonstration of ≥ 12% reversibility of FEV1 using a standard dose of salbutamol (up to 400 µg) within 30 minutes.
• Body Mass Index between 18 and 30. Body weight should be less than 100 kg.

You may not qualify if:

• Smokers
• Concomitant medications: Except for short- and long-acting β-agonists and medication which may be required to treat adverse events, all other medications, other than study drug should be avoided from screening until all of the study completion evaluations have been conducted. Paracetamol is acceptable.
• Medical conditions: history of clinically significant drug allergy; any significant medical condition. For example, a history of any pulmonary disorder other than asthma.
• Any surgical or medical condition which might significantly alter the distribution, metabolism or excretion of the drug.
• Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
• Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or longer if required by local regulation.
• Significant illness within the two weeks prior to dosing.
• A past personal or close family medical history of clinically significant cardiac abnormalities
• History of history of fainting, orthostatic hypotension, sinus arrhythmia, etc.
• A known hypersensitivity to Fluticasone propionate or drugs similar to Fluticasone propionate.
• History of immunocompromise, including a positive HIV test result.
• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
• History of drug or alcohol abuse within the 12 months prior to dosing

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative Site

Nuremberg, Germany

Location

MeSH Terms

Conditions

Asthma; Inflammation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis

  Investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 13, 2006
• First Posted: December 14, 2006
• Study Start: July 1, 2006
• Last Updated: June 22, 2007

Record last verified: 2007-06

Locations

DE (1)