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

NCT00868023 | Completed Phase 2

• 2 other identifiers: CCD-0809-PR-00382008-004842-10
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• FEV1 AUC0-12h

  Every week

Secondary Outcomes (1)

• 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

Study Arms (5)

1

EXPERIMENTAL

CHF 1535 DPI : BDP/Formo 400/24 µg

Drug: CHF 1535 Next DPI

2

ACTIVE COMPARATOR

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

Drug: Foster BDP/Formoterol

3

EXPERIMENTAL

CHF 1535 DPI : BDP/Formo 100/6 µg

Drug: CHF 1535 Next DPI

4

ACTIVE COMPARATOR

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

Drug: Foster BDP/Formoterol

5

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CHF 1535 Next DPI DRUG

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

1

Foster BDP/Formoterol DRUG

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

2

Placebo DRUG

Placebo

5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Pr DS SINGH

Manchester, M23 9QZ, United Kingdom

Location

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David Singh, Professor

  Medecines Evaluation Unit - Southmoor Road - M23 9QZ Manchester - UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

GB (1)