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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00411567
First received: December 13, 2006
Last updated: June 21, 2007
Last verified: June 2007
  Purpose

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


Condition Intervention Phase
Bronchial Asthma
Drug: inhaled corticosteroid therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Assess the Utility of Measuring Markers of Inflammation, to Detect Transition From Optimal to Sub-Optimal Inhaled Corticosteroid Therapy in Moderate-Severe Bronchial Asthma

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • Parameter/combination of parameters most sensitive to the ICS reduction
  • Collection of relative data to assess sample size calculations for subsequent studies

Estimated Enrollment: 26
Study Start Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Female subjects of child bearing potential must be using two forms of contraception or postmenopausal women must have no regular menstrual bleeding for at least 2 years prior to inclusion.
  • Body Mass Index between 18 and 30. Body weight should be less than 100 kg.

Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411567

Locations
Germany
Novartis Investigative Site
Nuernberg, Germany
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00411567     History of Changes
Other Study ID Numbers: CQAE397A2202
Study First Received: December 13, 2006
Last Updated: June 21, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
markers, inflammation, optimal, sub-optimal, corticosteroid, bronchial asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014