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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00411567
First Posted: December 14, 2006
Last Update Posted: June 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411567


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

ClinicalTrials.gov Identifier: NCT00411567     History of Changes
Other Study ID Numbers: CQAE397A2202
First Submitted: December 13, 2006
First Posted: December 14, 2006
Last Update Posted: June 22, 2007
Last Verified: June 2007

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

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