Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients (INHALATOR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01727024
First received: September 12, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

This study will compare the correct use of, and patient preference for two drug delivery systems (inhalers) in patients with COPD


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Tiotropium
Drug: Indacaterol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Difference between 2 drug delivery systems with respect to their correct use at day 1 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The correct use of 2 drug delivery systems will be measured and compared to each other. Participants will be given written instructions prior to the first treatment at day one and a check list will be used to report the proper handling of the devices


Secondary Outcome Measures:
  • Difference between 2 drug delivery systems with respect to their correct use after one week of handling [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The correct use of 2 drug delivery systems will be measured and compared to each other after one week of participants handling the devices.

  • Patient satisfaction with respect to the use of 2 drug delivery systems [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Patient satisfaction with the inhalers' use will be measured using a questionaire.

  • Patient preference of drug delivery system [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Patient preference between the 2 inhalers will be measured using a questionaire.

  • Comparison between comorbidities and difficulty with drug delivery system use [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Co-morbidities will be compared with difficulties of drug delivery system reported via a patient diary.


Estimated Enrollment: 140
Study Start Date: April 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indacaterol
Indacaterol via Onbrize Breezhaler® device
Drug: Indacaterol
Indacaterol via Onbrize Breezhaler® device once a day
Other Name: Onbrez Breezhaler
Active Comparator: Tiotropium
Tiotropium via Spiriva Respimat® device
Drug: Tiotropium
Tiotropium via Spiriva Respimat® device once a day

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure.
  2. Co-operative outpatients with a diagnosis of moderate COPD as classified by the GOLD Guidelines 2010 or grade A in GOLD 2011and including:

    • Smoking history of at least 10 pack years
    • FEV1/FVC < 70%

Exclusion criteria:

  1. Previous diagnosis of asthma
  2. Pregnant or nursing women
  3. Hospitalization or emergency room attendance due to COPD exacerbation within 3 months prior to visit 1 Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727024

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Brazil
Novartis Investigative Site Recruiting
Goiania, GO, Brazil, 74110-030
Novartis Investigative Site Recruiting
Belo Horizonte, MG, Brazil, 30130-100
Novartis Investigative Site Suspended
Belo Horizonte, MG, Brazil, 30150-281
Novartis Investigative Site Recruiting
Rio de Janeiro, RJ, Brazil, 20551-030
Novartis Investigative Site Recruiting
Porto Alegre, RS, Brazil, 90020-090
Novartis Investigative Site Recruiting
Porto Alegre, RS, Brazil, 90610-000
Novartis Investigative Site Recruiting
Florianopolis, SC, Brazil, 88040-970
Novartis Investigative Site Recruiting
Ribeirao Preto, SP, Brazil, 14048-900
Novartis Investigative Site Recruiting
Sao Paulo, SP, Brazil, 04039-004
Novartis Investigative Site Recruiting
São Paulo, SP, Brazil, 01224-000
Novartis Investigative Site Withdrawn
São Paulo, SP, Brazil, 04023-900
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01727024     History of Changes
Other Study ID Numbers: CQAB149BBR02
Study First Received: September 12, 2012
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Breezhaler
Respimat
Indacaterol
Tiotropium

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014