A Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Inhaled CHF6001 DPI in Asthmatics
- Registration Number
- NCT01689571
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
The study is designed to look at the safety, tolerability and efficacy of 2 different doses of the study drug (CHF6001, a PDE4 inhibitor) in asthmatics, when given by inhalation, once a day for 9 days. The efficacy will be evaluated by measuring the protective effect of CHF 6001 after an allergen challenge.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- written informed consent obtained
- Non smoking or ex-smokers from at least 1 year prior to study entry
- Males of females between 18 and 60 years inclusive
- Body Mass Index between 18 and 32 kg/m2
- Ability to be trained about the proper use of the inhalation device and to perform spirometry
- With mild to moderate allergic asthma as defined by the GINA guideline, steroid naive
- Atopy to at least one common aeroallergen
- Positive allergen-induced Early Asthmatic Response and Late Asthmatic Response at screening
- Ability to produce an adequate sputum sample
- Post-menopausal women, women of not childbearing potential or males and females of childbearing potential willing (they or their partner) to use a reliable method of contraception.
Exclusion Criteria
- Worsening of asthma or respiratory tract infection prior to study entry
- History of life-threatening asthma or hospitalization for asthma prior to the study entry
- Pregnant or lactating women
- History of clinically significant hypotensive episodes or fainting, dizziness or light-headedness
- History or symptoms of clinically relevant neurologic disease
- Symptomatic hay fever
- Unstable concurrent disease that may impact the feasibility of the study
- Use of systemic corticosteroids, nebulised bronchodilator or oral beta2-agonist
- Use of leukotrienes modifiers, roflumilast or cromoglycate
- Use of long acting beta2-agonist or inhaled corticosteroids
- Use of short-acting or long-acting non-sedatives antihistamines
- Use of any other medication for the treatment of allergic asthma other than salbutamol
- Having received an investigational medicinal drug within 30 days prior to study entry
- Blood drawn of at least 250 ml in the previous 45 days
- Ongoing use of tobacco
- Other lung disease
- Recent history of alcohol dependency
- Inability to comply with the study protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo DPI Placebo Placebo by inhalation for 9 days CHF6001 DPI Dose 2 CHF6001 CHF6001 by inhalation for 9 days CHF6001 DPI Dose1 CHF6001 CHF6001 by inhalation for 9 days
- Primary Outcome Measures
Name Time Method Allergen challenge after 9 days of treatment
- Secondary Outcome Measures
Name Time Method Induced Sputum After 9 days of treatment Methacholine challenge After 9 days of treatment
Trial Locations
- Locations (3)
Hammersmith Medicines Research
🇬🇧London, United Kingdom
Respiratory Clinical Trials
🇬🇧London, United Kingdom
Medicines Evaluation Unit
🇬🇧Manchester, United Kingdom