Study of the impact of indacaterol on the individual lives and health status of patients with chronic obstructive pulmonary disease (COPD)

INdacaterol effect on Health status in COPD: A real Life patient Experience prospective observational study (INHALE)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN67880705

Enrollment

200

Registered

2012-05-10

Start date

2012-05-01

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory Other chronic obstructive pulmonary disease

Interventions

Patients in the study will have been prescribed indacaterol as part of routine clinical practice. Patients will be asked to complete the COPD Assessment Test (CAT) at baseline, 6-8 weeks and 6 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with active diagnosis of COPD, confirmed by spirometry, documented in medical notes 2. Patients who are newly-prescribed indacaterol as part of routine clinical practice

Exclusion criteria

Exclusion criteria: 1. Patients who have previously received maintenance therapy for COPD symptoms e.g. Long acting beta agonists (LABAs), long acting antimuscarinics (LAMAs), LABA + inhaled corticosteroid (ICS) 2. Patients unable or unwilling to consent to participation in the study 3. Patients unable or unwilling to complete the study questionnaires 4. Patients who have participated in any interventional clinical trial for indacaterol 5. Patients who have previously been prescribed indacaterol

Design outcomes

Primary

Measure	Time frame
Absolute CAT scores and mean standard deviation (SD) change from baseline in CAT score at 6-8 weeks after initiation of indacaterol	—

Secondary

Measure	Time frame
1. Mean (SD) change from baseline in CAT score at 6 months fter initiation of indacaterol 2. Qualitative description of the impact of indacaterol on the atient?s life at 6-8 weeks after initiation of indacaterol 3. Distribution and summary statistics of physician GETE at 6-8 eeks and 6 months after initiation of indacaterol 4. Distribution and summary statistics of patient GETE at 6 onths after initiation of indacaterol 5. Distribution and summary statistics of FEV1 throughout the bservation period 6. Distribution and summary statistics of MRC dyspnoea cores throughout the observation period 7. Description of study sample at baseline	—

Measure

Time frame

1. Mean (SD) change from baseline in CAT score at 6 months fter initiation of indacaterol 2. Qualitative description of the impact of indacaterol on the atient?s life at 6-8 weeks after initiation of indacaterol 3. Distribution and summary statistics of physician GETE at 6-8 eeks and 6 months after initiation of indacaterol 4. Distribution and summary statistics of patient GETE at 6 onths after initiation of indacaterol 5. Distribution and summary statistics of FEV1 throughout the bservation period 6. Distribution and summary statistics of MRC dyspnoea cores throughout the observation period 7. Description of study sample at baseline

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026