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

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Indacaterol; Drug: Tiotropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01727024

CQAB149BBR02

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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%

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Indacaterol (QAB149) Breezhaler®

Experimental group

Description:

In period 1, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days, followed by a 7-day washout. In period 2, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.

Treatment:

Drug: Indacaterol

Tiotropium Respimat®

Active Comparator group

Description:

In period 1, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days, followed by a 7-day washout. In period 2, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.

Treatment:

Drug: Tiotropium