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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-10-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

CHF 1535 DPI : BDP/Formo 400/24 µg

Group Type EXPERIMENTAL

CHF 1535 Next DPI

Intervention Type DRUG

CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)

2

CHF 1535 pMDI HFA : BDP/Formo 400/24 µg

Group Type ACTIVE_COMPARATOR

Foster BDP/Formoterol

Intervention Type DRUG

BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)

3

CHF 1535 DPI : BDP/Formo 100/6 µg

Group Type EXPERIMENTAL

CHF 1535 Next DPI

Intervention Type DRUG

CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg)

4

CHF 1535 pMDI HFA : BDP/Formo 100/6 µg

Group Type ACTIVE_COMPARATOR

Foster BDP/Formoterol

Intervention Type DRUG

BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg

5

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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CHF 1535 Next DPI

CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)

Intervention Type DRUG

Foster BDP/Formoterol

BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 400/24 µg)

Intervention Type DRUG

CHF 1535 Next DPI

CHF 1535 DPI : BDP/Formoterol : 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg)

Intervention Type DRUG

Foster BDP/Formoterol

BDP/Formoterol 100/6 µg (daily dose : BDP/Formoterol : 100/6 µg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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 ΔFEV1 ≥ 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No