A Study in Patients With Chronic Obstructive Pulmonary Disease

NCT01245569 | Completed Phase 3

• 2 other identifiers: CCD-0910-PR-00212009-014410-10
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to determine the effects on health status and spirometric values of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), over a 12-week treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Transition Dyspnoea Index (TDI) score

  At day 84

• Area Under the Curve (AUC) 0-30min standardized by time of change from pre-dose in Forced Expiratory Volume in one second (FEV1)

  After drug inhalation in the morning of day 1

Secondary Outcomes (4)

• Change from baseline in pre-dose morning Forced Expiratory Volume in one second (FEV1)

  At each clinic visit

• Change from pre-dose in Forced Vital Capacity (FVC)

  At 5, 15, 30 min after drug intake, at day 1 and day 84

• Change from baseline in the St George's Respiratory Questionnaire (SGRQ)component and total scores

  At day 84

• Change from baseline in pre-dose and in post-dose distance walked (6 Minute Walking Test - 6MWT) (in a subset of at least 50 % of patients from pre-selected sites)

  At day 84

Study Arms (2)

Foster®

EXPERIMENTAL

Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP "extrafine" 400 µg plus FF 24 µg).

Drug: Foster® 100/6 µg/unit dose

Seretide® Accuhaler®

ACTIVE COMPARATOR

Seretide® Accuhaler® (fluticasone 500 μg plus salmeterol 50 μg/actuation), 1 inhalation b.i.d. (daily dose of fluticasone 1000 μg plus salmeterol 100 μg).

Drug: Seretide Accuhaler® 500/50 µg/actuation

Interventions

Foster® 100/6 µg/unit dose DRUG

Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP "extrafine" 400 µg plus FF 24 µg).

Foster®

Seretide Accuhaler® 500/50 µg/actuation DRUG

Seretide® Accuhaler® (fluticasone 500 μg plus salmeterol 50 μg/actuation), 1 inhalation b.i.d. (daily dose of fluticasone 1000 μg plus salmeterol 100 μg).

Seretide® Accuhaler®

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or once applicable written informed consent obtained by legal representative.
• Outpatients with a diagnosis of COPD and including:
• Smoking history of at least 10 pack years defined as \[(number of cigarettes smoked per day) x (number of years of smoking) / 20\], both current and ex-smokers are eligible.
• Use of bronchodilators in the previous 2 months to visit 1.
• Post-bronchodilator FEV1 \< 60% of the predicted normal value.
• Post-bronchodilator FEV1/FVC \< 0.7.
• A ≥ 5% response to a reversibility test.
• A Baseline Dyspnoea Index (BDI) focal score less or equal than 10 (to be met also at visit 2).
• History of no more than one COPD exacerbation in the previous 12 months (without considering the last 2 months) to visit 1.
• A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Accuhaler®, circular moulded plastic inhaler) inhalers.

You may not qualify if:

• Clinically relevant respiratory disorders.
• Current diagnosis of asthma or respiratory disorders other than COPD.
• Clinically significant laboratory and ECG abnormalities indicating a significant or unstable concomitant disease which may impact the feasibility of the results of the study according to investigator's judgement.
• Patients with COPD exacerbation in the 2 months prior to screening and during the study period.
• Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
• Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Policlinico Umberto I - VIII Padiglione

Rome, Rome, 00161, Italy

Location

Related Publications (1)

• Singh D, Nicolini G, Bindi E, Corradi M, Guastalla D, Kampschulte J, Pierzchala W, Sayiner A, Szilasi M, Terzano C, Vestbo J; FUTURE (Foster Upgrades TherapeUtic care in REspiratory disease) study group. Extrafine beclomethasone/formoterol compared to fluticasone/salmeterol combination therapy in COPD. BMC Pulm Med. 2014 Mar 12;14:43. doi: 10.1186/1471-2466-14-43.

  PMID: 24621109 RESULT

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Foster Home Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dave Singh, MD

  The Medicine Evaluation Unit - Manchester, UK

  PRINCIPAL INVESTIGATOR

• Jorgen Vestbo, MD

  Dept. of Cardiology and Respiratory Medicine - Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 22, 2010
• Study Start: April 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

IT (1)