Clinical study to test that the drug CHF 1535 100/6 (fixed combination of an anti-inflammatory drug and relaxing airways drug) delivered via pressurized inhaler using or not a spacer device is as effective in adolescent population as the licensed free combination of the same substances and compare it with administration in adults.

• 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: EUCTR2011-005108-14-PL
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-20
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

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

Inclusion Criteria

1. Male and female adolescents, aged = 12 and < 18 years or male and female adults, aged = 18
and = 65 years.
2. Written informed consent obtained by the patient in case of adult patients and by parents/legal
representative and by the minor (according to local regulation).
3. A diagnosis of asthma as defined in the GINA guidelines (updated 2010) 6 months before the
screening visit.
4. Male/female adolescent and adult patients with asthma stable enough, according to GINA
guidelines (updated 2010) and based on the Investigator’s opinion, to allow a wash out period
from inhaled BDP of 2 days before study each single day study treatments and any ICS other
than BDP of 1 day before each single day study treatments.
5. Male/female adolescents and adults asthmatic patients already treated with ICS or ICS/longacting
inhaled ß2-agonists or using short-acting inhaled ß2-agonists as reliever to control
asthma symptoms.
6. Adolescents and adults with a forced expiratory volume in one second (FEV1) > 70% of
predicted values (% pred) after withholding short acting ß2-agonist treatment for a minimum of
6 h prior to screening or 24 hours in case of long acting ß2-agonist.
7. Non- or ex-smokers who smoked less than 5 pack-years (e.g. < 20 cigarettes per day for 5 years)
and stopped smoking for at least 1 year.
8. A cooperative attitude and ability to be trained about the proper use of pMDI with and without
a spacer device and compliant to study procedures.
9. Body mass index (BMI) =18.5 and = 32 kg/m2
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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. Pregnant or breast-feeding female patients. Sexually active female not using efficient
contraception throughout the entire study period (e.g. oestro-progestatives, condoms,
intrauterine devices). A urinary pregnancy test will be performed at screening and treatment
visits (mandatory in the adult population and at discretion of the investigator in the adolescent
population) in women of childbearing potential;
2. Having received an investigational drug within 2 months before the screening visit (Visit 1)
3. Diagnosis of COPD, in the adult patients, as defined by the current GOLD guidelines (updated
2010).
4. Known hypersensitivity to the active treatments.
5. Inability to perform the required breathing technique and blood sampling.
6. Hospitalization due to exacerbation of asthma within 1 month prior to screening visit.
7. Lower respiratory tract infection within 1 month prior to screening visit;
8. Obesity, i.e. > 97% weight percentile by local standards.
9. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic,
endocrine diseases, that may interfere with patient’s safety, compliance, or study evaluations,
according to the Investigator’s opinion;
10. History of drug addiction or excessive use of alcohol (weekly intake in excess of 28 units
alcohol; one unit being a glass of beer, wine or a measure of spirits), or excessive consumption
of xanthine containing substances (daily intake in excess of 5 cups of coffee, tea, cola, etc) or
psychological or other emotional problems likely to invalidate informed consent, or limit the
ability of the subject to comply with the protocol requirements;
11. Treatment with a xanthine derivative (e.g. theophylline) formulations in the 4 weeks prior to
screening visit;
12. Blood donation (450 mL or more) (for the adult population) or significant blood loss in the 12
weeks before the screening visit.

Study & Design

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