Clinical trial NCT00411567: A Study to Assess the Efficacy of Inhaled Corticosteroid (ICS) Therapy in Moderate-Severe Bronchial Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Bronchial Asthma
Keywords: markers, inflammation, optimal, sub-optimal, corticosteroid, bronchial asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in inflammatory parameters in response to a decrease in ICS compared to no change in therapy after 2 and 4 weeks
Secondary outcomes:
measure: Parameter/combination of parameters most sensitive to the ICS reduction
measure: Collection of relative data to assess sample size calculations for subsequent studies
Other outcomes:
Locations:
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: