The Effect of Beclomethasone/Formoterol in Extra-fine Formulation on Quality of Life and SAD in COPD Patients.

NCT04421742 | Completed

• 1 other identifier: 9769 del 15.03.2017
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with chronic obstructive pulmonary disease (COPD), small-airway dysfunction (SAD) is considered a key element and a functional consequence of the pathology. However, the exact role of SAD as a specific 'pharmacological target' is not yet fully known. Objectives In an open-label prospective study, we aimed to ascertain whether an extra-fine formulation of Beclomethasone dipropionate/Formoterol fumarate (BDP/FF) NEXThaler® 100/6 μg b.i.d. can improve the impact of the disease on the quality of daily life of COPD patients, acting on SAD. Methods We studied COPD patients with severe airflow obstruction and 1 moderate exacerbation in the previous year, being treated with BDP/FF NEXThaler® for 12 weeks. They underwent three visits, at the start of the treatment (V1), at 6th week (V2) and at 12th week (V3). By the impulse oscillometry system and by spirometry and plethysmography we measured at each visit the fall in resistance from 5 to 20 Hz (R5-R20) and the residual volume/total lung capacity (RV/TLC). COPD Assessment Test (CAT) and the modified Medical Research Council (mMRC) questionnaire were also measured at each visit to assess the impact of the disease on the quality of life of the patients.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (3)

• Change (Improvement) of CAT (Italian version)

  The CAT (COPD Assessment Test) is a questionnaire suitable for completion by all patients diagnosed with COPD. It comprises 8 simple questions that most patients should be able to understand and complete independently. The CAT has a scoring range of 0-40, where each question is ranging 0-5. A CAT score\>10 indicates a medium/high impact level of COPD. A difference or change of 2 or more units over 2 to 3 months in a patient suggests a clinically significant difference or change in health status (minimal clinically relevant change, often referred to as the Minimum Clinically Important Difference or MCID).

  Change from Baseline CAT at 12th week

• Change (Improvement) of mMRC (Italian version)

  The modified Medical Research Council (mMRC) dyspnoea scale is a questionnaire that consists of five statements about perceived breathlessness: grade 1, "I only get breathless with strenuous exercise"; grade 2, "I get short of breath when hurrying on the level or up a slight hill"; grade 3, "I walk slower than people of the same age on the level because of breathlessness or have to stop for breath when walking at my own pace on the level"; grade 4, "I stop for breath after walking 100 yards or after a few minutes on the level"; grade 5, " I am too breathless to leave the house". Patients are asked about their perceived breathlessness and are then classified into MRC dyspnoea grades according to how they perceive their disability.

  Change from Baseline mMRC at 12th week

• Change (Improvement) of R5-R20 (kPa x s x L-1)

  The IOS was performed with the Jaeger MasterScreen-IOS device following the standard recommendations. Respiratory resistances at 5 Hz and 20 Hz (R5 and R20, kPa x s x L-1) were used as a total and proximal airway resistance index, respectively, and the resistance drop from 5 to 20 Hz (R5 - R20, kPa x s x L-1) was considered as an indirect index of resistance of the peripheral airways. The oscillometer was calibrated daily.

  Change from Baseline R5-R20 at 12th week

Study Arms (1)

43 COPD

COPD patients with severe airflow obstruction and 1 moderate exacerbation in the previous year being treated with BDP/FF NEXThaler® 100/6 μg b.i.d. for 12 weeks

Drug: Beclomethasone Dipropionate/Formoterol Fumarate

Interventions

Beclomethasone Dipropionate/Formoterol Fumarate DRUG

BDP/FF NEXThaler® 100/6 μg b.i.d.

Also known as: Foster NEXThaler®

43 COPD

Eligibility Criteria

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

Study Population

COPD patients of the outpatient clinic of the Respiratory Disease Unit of the University Hospital in Parma (Italy)

You may qualify if:

• a documented diagnosis of COPD defined according to the guidelines of the American Thoracic Society (ATS) / European Respiratory Society (ERS);
• smokers or former smokers with a smoking history of at least 10 pack / years;
• subjects with a post-bronchodilator forced expiratory volume at the 1st second (FEV1)/ forced vital capacity (FVC) ratio of \< 0.7 and a FEV1 \<50% pred;
• subjects with a high impact of the COPD on their health status (CAT≥10);
• clinical history of at least 1 moderate exacerbation / year;
• COPD patients being treated with BDP/FF NEXThaler® 100/6 μg in extra-fine formulation no more than 1 (one) week before enrollment.

You may not qualify if:

• an exacerbation in the four weeks prior to enrollment;
• other coexisting lung diseases (bronchial asthma, restrictive diseases or bronchiectasis) and severe co-morbidities associated with COPD, such as uncontrolled cardiovascular disease, pneumonia or cancer;
• pregnant patients;
• subjects unable to meet the criteria of acceptability and repeatability of pulmonary function tests, according to the ATS / ERS document

Sponsors & Collaborators

• Alfredo Antonio Chetta: lead
• University of Parma: collaborator

Study Sites (1)

Department of Medicine and Surgery, Respiratory Disease and Lung Function Unit, University of Parma, Italy

Parma, 43125, Italy

Location

Related Publications (18)

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  PMID: 24953015 RESULT

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• Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993 Mar;16:5-40. No abstract available.

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• Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.

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  PMID: 24621681 RESULT

• Han MK, Quibrera PM, Carretta EE, Barr RG, Bleecker ER, Bowler RP, Cooper CB, Comellas A, Couper DJ, Curtis JL, Criner G, Dransfield MT, Hansel NN, Hoffman EA, Kanner RE, Krishnan JA, Martinez CH, Pirozzi CB, O'Neal WK, Rennard S, Tashkin DP, Wedzicha JA, Woodruff P, Paine R 3rd, Martinez FJ; SPIROMICS investigators. Frequency of exacerbations in patients with chronic obstructive pulmonary disease: an analysis of the SPIROMICS cohort. Lancet Respir Med. 2017 Aug;5(8):619-626. doi: 10.1016/S2213-2600(17)30207-2. Epub 2017 Jun 28.

  PMID: 28668356 RESULT

• Hogg JC, Chu FS, Tan WC, Sin DD, Patel SA, Pare PD, Martinez FJ, Rogers RM, Make BJ, Criner GJ, Cherniack RM, Sharafkhaneh A, Luketich JD, Coxson HO, Elliott WM, Sciurba FC. Survival after lung volume reduction in chronic obstructive pulmonary disease: insights from small airway pathology. Am J Respir Crit Care Med. 2007 Sep 1;176(5):454-9. doi: 10.1164/rccm.200612-1772OC. Epub 2007 Jun 7.

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• De Backer W, Devolder A, Poli G, Acerbi D, Monno R, Herpich C, Sommerer K, Meyer T, Mariotti F. Lung deposition of BDP/formoterol HFA pMDI in healthy volunteers, asthmatic, and COPD patients. J Aerosol Med Pulm Drug Deliv. 2010 Jun;23(3):137-48. doi: 10.1089/jamp.2009.0772.

  PMID: 20109122 RESULT

• de Boer AH, Gjaltema D, Hagedoorn P, Frijlink HW. Can 'extrafine' dry powder aerosols improve lung deposition? Eur J Pharm Biopharm. 2015 Oct;96:143-51. doi: 10.1016/j.ejpb.2015.07.016. Epub 2015 Jul 26.

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• Virchow JC, Poli G, Herpich C, Kietzig C, Ehlich H, Braeutigam D, Sommerer K, Haussermann S, Mariotti F. Lung Deposition of the Dry Powder Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Using NEXThaler(R) Device in Healthy Subjects, Asthmatic Patients, and COPD Patients. J Aerosol Med Pulm Drug Deliv. 2018 Oct;31(5):269-280. doi: 10.1089/jamp.2016.1359. Epub 2018 Jul 10.

  PMID: 29989511 RESULT

• Voshaar T, Spinola M, Linnane P, Campanini A, Lock D, Lafratta A, Scuri M, Ronca B, Melani AS. Comparing usability of NEXThaler((R)) with other inhaled corticosteroid/long-acting beta2-agonist fixed combination dry powder inhalers in asthma patients. J Aerosol Med Pulm Drug Deliv. 2014 Oct;27(5):363-70. doi: 10.1089/jamp.2013.1086. Epub 2013 Dec 3.

  PMID: 24299501 RESULT

• Pisi R, Aiello M, Piraino A, Paleari D, Frizzelli A, Bertorelli G, Chetta A. Beclomethasone/Formoterol in Extra-Fine Formulation Improves Small Airway Dysfunction in COPD Patients. Pulm Ther. 2021 Jun;7(1):133-143. doi: 10.1007/s41030-021-00144-x. Epub 2021 Feb 4.

  PMID: 33538996 DERIVED

Related Links

• Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018
• CAT Development Steering Group: COPD Assessment Test - Healthcare Professional User Guide. Issue 4: November 2018.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Beclomethasone; Formoterol Fumarate

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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Alfredo A Chetta, MD

  Hospital-University of Parma, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 9, 2020
• Study Start: May 31, 2017
• Primary Completion: February 8, 2019
• Study Completion: May 23, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available starting from 6 months after publication
• Access Criteria: Data will be shared with the Principal Investigator and the authors, if requested, by e-mail contacting

Locations

IT (1)