A study to look at the safety, tolerability and efficacy of repeated doses of different concentrations of the study drug during controlled inhalation of allergens in adult asthmatics.

• Conditions: asthma; MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001483-29-GB
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-21
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Written informed consent (IC) prior to any studyrelated
procedures;
2.Non or exsmokers
3.Male or female aged between 18 and 60 years;
4.Body mass index between 18 and 32 kg/m2 inclusively;
5.A cooperative attitude and ability to be trained about the proper use of the Aerolizer® DPI and to perform spirometry;
6.Diagnosis of intermittent or persistent mild to moderate allergic asthma, steroidnaïve and generally in good health;
7.Predisposition to an allergic reaction (atopy) to at least one common
aeroallergen
8.At the time of randomisation, a confirmed dualresponder”
having demonstrated both a late asthmatic response and an early asthmatic response.
9.Sputum producer cohort only: able to produce an adequate induced sputum sample,
10 hours after the allergen challenge at screening.
10.No regular antiasthmatic medication except salbutamol inhaler on an as needed basis” starting from the first screening visit;
11.Willing to use an approved method of contraception from the time of dose administration and until 90 days after the last dose of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Worsening of asthma or a respiratory tract infection within 4 weeks of any screening procedure requiring a change in asthma therapy or is deemed clinically significant by the investigator;
2.History of lifethreatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures or hospitalisation (including emergency room visits) for the treatment of asthma within 3 months of any screening procedure, or have been hospitalized for asthma more than twice in last 12 months;
3.Pregnant or lactating women.
4.History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness;
5.History or symptoms of significant neurologic disease, including transient
ischemic attack (TIA), stroke, seizure disorder, or behavioural disturbances;
6.Symptomatic with hay fever at screening or predicted to have symptomatic hay fever during the study;
7.Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease, uncontrolled gastrointestinal disease; neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, or other which may impact the feasibility of the results of the study.
8.Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
9.History of serious adverse reaction, severe hypersensitivity or allergy to any drug or in any other circumstance (e.g. anaphylaxis);
10.Use of systemic corticosteroids, nebulised bronchodilators, oral beta2agonists 6 weeks prior to study entry;
11.Use of leukotrienes modifiers, roflumilast, cromoglycate 4 weeks prior to study entry;
12.Use of long acting 2agonists and/or inhaled corticosteroids (ICS) within 6 months prior to study entry;
13.Use of short or longacting nonsedative
antihistamines within 2 or 7 days, respectively, prior to screening until the end of the study;
14.Chronic use of any other medication for treatment of allergic lung disease other than shortacting bronchodilators taken as needed during the study;
15.Receipt of an investigational drug treatment within the preceding 30 days, or a longer and more appropriate time as determined by the Investigator
16.Blood draws of 250 millilitres (mL) or more within 45 days prior to enrolment in the study;
17.Ongoing use of tobacco products or previous usage within the past 12 months or past history greater than or equal to 5 packyears.
18.Lung disease other than intermittent or mild to moderate allergic asthma;
19.Recent (less than 1 year) history of alcohol dependency;
20.Unwillingness or inability to comply with the study protocol for any other reason;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified