Comparative Study on Usability of Inhaler Devices in Adults With Asthma or COPD

NCT02757209 | Completed

• 1 other identifier: PMC-101-APT
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomized, multi-center, active-controlled, repeated measures design study in male and female patients 60 years of age and older with persistent asthma or COPD. Study will be conducted in 4 Italian University/Hospital Centers: Ferrara, Parma, Cassano delle Murge (Ba), Tradate. The primary efficacy parameter of the study is inhaler device usability (expressed as total number of repeated attempts required to achieve optimal use).

Conditions

Asthma; COPD

Keywords

ASTHMA; COPD; budesonide; formoterol; Salmeterol; Fluticasone; Spiromax; DPI; Diskus

Outcome Measures

Primary Outcomes (1)

• Usability of Spiromax , Turbuhaler and Diskus devices

  number of attemps required to acheive optimal use

  day 1

Secondary Outcomes (3)

• Short term maintenance of correct use

  1 weeks of treatment (cross sectional phase)

• Long term maintenance of correct use

  8 weeks of treatment at the end of the longitudinal phase

• Patient's preference for different devices

  8 weeks of treatment at the end of the longitudinal phase

Study Arms (3)

Spiromax Inhaler

ACTIVE COMPARATOR

Evaluation of correct use of Spiromax inhaler - DuoResp Spiromax 160 (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate), either one inhalation twice a day (morning and evening) or two inhalations twice a day (morning and evening), for 1 week. Additional 8 weeks in one subgroup

Device: Spiromax (budesonide/formoterol); Device: Turbohaler (budesonide/formoterol); Device: Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate)

Turbohaler inhaler

ACTIVE COMPARATOR

Turbohaler® - Symbicort® 160/4.5 (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate). Dose of one inhalation twice a day (mornig and evening) or two inhalations twice a day (morning and evening), for 1 week. Additional 8 weeks in one subgroup

Device: Spiromax (budesonide/formoterol); Device: Turbohaler (budesonide/formoterol); Device: Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate)

Diskus Inhaler

ACTIVE COMPARATOR

Diskus® inhaler - Seretide Diskus 50/250 mcg ® or 50/500 mcg (50 mcg salmeterol \& 250/500 mcg fluticasone propionate). Dose of one inhalation twice a day for 1 week. Additional 8 weeks in one subgroup

Device: Spiromax (budesonide/formoterol); Device: Turbohaler (budesonide/formoterol); Device: Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate)

Interventions

Spiromax (budesonide/formoterol) DEVICE

DuoResp Spiromax 160 (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate), either one inhalation twice a day (morning and evening) or two inhalations twice a day (morning and evening), for 1 week. Additional 8 weeks in one subgroup

Diskus Inhaler; Spiromax Inhaler; Turbohaler inhaler

Turbohaler (budesonide/formoterol) DEVICE

Turbohaler® (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate)- Symbicort® 160/4.5. Dose of one inhalation twice a day (mornig and evening) or two inhalations twice a day (morning and evening), for 1 week. Additional 8 weeks in one subgroup

Diskus Inhaler; Spiromax Inhaler; Turbohaler inhaler

Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate) DEVICE

Diskus® inhaler(50mcg salmeterol\&250/500mcg fluticasone propionate)-Seretide Diskus 50/250mcg® or 50/500mcg.Dose of 1inhalation twice a day for1 week.Additional 8 weeks in1subgroup

Diskus Inhaler; Spiromax Inhaler; Turbohaler inhaler

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent. Written informed consent/assent signed and dated by the patient before conducting any study related procedure.
• Age. Male or female patients 60 years and older as of the Screening Visit (SV)
• Asthma or COPD diagnosis. Previous or new Asthma/COPD diagnosis in accordance with the Global Initiative for Asthma (GINA) or Global initiative for chronic Obstructive Lung Disease (GOLD).
• Severity of respiratory disease: Persistent asthma, with a pre-bronchodilator FEV1 of 40-85% predicted for age, height, gender and race, for a minimum of 3 months duration. COPD, with a pre-bronchodilator FEV1 of 40-85% predicted for age, height, gender and race, for a minimum of 3 months.
• Stable state. Patients without exacerbations and without change in the previous treatment for at least 4 weeks prior to the visit 1 as defined by clinical history.
• Comorbidities. No concomitant severe comorbidities which could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study observations/results, or put the patient at increased risk during the study.
• Current Therapy: Patients needing combination ICS/LABA already in treatment with PDI (Turbohaler) or Diskus.
• Short-Acting beta2-Agonists: All patients must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhalation aerosol at the visit 1 for use as needed for the duration of the study.
• Patients must be able to withhold all inhaled short-acting betapathomimetic bronchodilators for at least 6 hours prior to all study visits.
• Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (visits, record-keeping, etc.).

You may not qualify if:

• Asthma severity. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
• COPD severity. COPD with a pre-bronchodilator FEV1 \< 30% and/or FEV1 30-50% but requiring long term oxygen therapy.
• Exacerbations. Any asthma/COPD exacerbation within one month of the visit 1. A patient must not have had any hospitalisation for asthma/COPD within 6 months prior to the visit 1.
• Respiratory infections. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the visit 1.
• Comorbidities. Historical or current evidence of a clinically significant comorbidity including, but not limited to: cardiovascular (e.g. congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological (e.g. immunologic compromise), neuropsychological, endocrine (e.g. uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g. poorly-controlled peptic ulcer, gastroesophageal reflux disease), pulmonary (e.g. bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, lung cancer) or history of a positive test for HIV, hepatitis B or hepatitis C infection. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the patient at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
• History of any adverse reaction. History of any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the inhalers used in the study (e.g. lactose in the dry powder inhalers).
• Use of immunosuppressive medications. Use of immunosuppressive medications within 12 weeks prior visit 1 and during the study, including use of systemic corticosteroids. Immunotherapy at a stable dose for at least 90 days prior to the visit 1 and throughout the study for the treatment of allergies is permitted.
• Smoking. Current smokers are excluded. A patient may not have used tobacco products within the past one year (e.g., cigarettes, cigars, chewing tobacco, or pipe tobacco).
• Concomitant participation to other research study. Participation to another research study investigational drug study within the 30 days (starting at the final follow-up visit) preceding the visit 1 or planned participation in another investigational drug study at any time during this study.

Sponsors & Collaborators

• Consorzio Futuro in Ricerca: lead

Study Sites (3)

3) Fondazione S. Maugeri - IRCCS - Dipartimento di Pneumologia Riabilitativa

Cassano delle Murge, Bari, 70020, Italy

Location

University Hospital S Anna

Ferrara, Fe, 44124, Italy

Location

4) Clinica di Malattie dall'Apparato Respiratorio Fondazione Salvatore Maugeri

Tradate, Varese, 21049, Italy

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Papi, MD

  Università degli Studi di Ferrara

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: May 2, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 29, 2018

Record last verified: 2018-01

Locations

IT (3)