Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients

Asthma Clinical Trial

Official title:

A Phase II, Multinational, Multicentre, Double Blind, Double Dummy, Randomised, 5-way Cross-over, Placebo and Active Controlled Clinical Study to Test the Non-inferiority of a Single Dose of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg Dry Powder) Via NEXT™ DPI 1 or 4 Inhalations Versus CHF 1535 (Beclomethasone Dipropionate 100 µg Plus Formoterol Fumarate 6 µg) pMDI With HFA-134a Propellant 1 or 4 Puffs on FEV1 AUC0-12h in Partly Controlled Adult Asthmatic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868023
• Other study ID #: CCD-0809-PR-0038
• Secondary ID: 2008-004842-10
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2009
• Last updated: March 28, 2017
• Start date: February 2009
• Est. completion date: October 2009

Study information

• Verified date: March 2017
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over

Description:

To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT DPI and CHF 1535 via HFA-134a "extrafine" pMDI in partly controlled adult asthmatic patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient's written informed consent obtained prior to any study-related procedures.

• Outpatient male or female aged = 18 years.

• Evidence for "partly controlled" asthma in the 2 weeks before the screening visit

• Under previous inhaled corticosteroids (ICS) treatment at the screening visit

• Forced expiratory volume in the first second (FEV1) = 60% and = 90% of the predicted normal values at the screening visit.

• A documented positive response to the reversibility test at the screening visit, defined as ?FEV1 = 12% and = 200 mL over baseline, 30 minutes after 400 µg salbutamol pMDI

• Patients free of long-acting beta2-agonists (LABAs) treatment for at least 2 weeks before the screening visit.

• Patients free of short-acting beta2-agonists (SABAs) treatment for at least 6 hours before the screening visit.

• Non-smokers or ex-smokers

Exclusion Criteria:

• Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they are menopausal or are using effective and acceptable methods of contraception.

• Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.

• History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit) within 1 year before screening.

• Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit.

• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)

• History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.

• Diagnosis of restrictive lung disease.

• Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.

• Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.

• Allergy, sensitivity or intolerance to study drugs or excipients.

• Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CHF 1535 Next DPI
CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
• Foster BDP/Formoterol
BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)
• CHF 1535 Next DPI
CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg)
• Foster BDP/Formoterol
BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	Pr DS SINGH	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 AUC0-12h		Every week
Secondary	FVC as assessed at the same time points as for FEV1; Peak FEV1 in terms of absolute values and % of change from baseline Safety evaluation		Every week

External Links

•   Study Record on EU Clinical Trials Register including results