---
title: A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device
nct_id: NCT01484197
overall_status: COMPLETED
phase: PHASE2
sponsor: Novartis Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Asthma
countries: Germany, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01484197.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01484197"
ct_last_update_post_date: 2015-04-01
last_seen_at: "2026-05-12T06:54:13.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device

**Official Title:** A Multi-centre, Randomized, Double-blind, Double-dummy, Multiple-dose, Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Orally Inhaled Indacaterol Administered as Either PulmoSphere or Lactose-blend Powder Via the Concept1 Device in Adult Patients With Persistent Asthma

**NCT ID:** [NCT01484197](https://clinicaltrials.gov/study/NCT01484197)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 36
- **Lead Sponsor:** Novartis Pharmaceuticals
- **Conditions:** Asthma
- **Start Date:** 2011-11
- **Completion Date:** 2012-05
- **CT.gov Last Update:** 2015-04-01

## Brief Summary

This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Male and female patients with asthma
* Aged 18 or above
* Patients using inhaled corticosteroid (with or without long acting beta agonist)
* Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist

Exclusion Criteria:

* Asthma exacerbations in previous 6 months
* COPD or other pulmonary disease
* Excessive use of short acting beta agonists
```

## Arms

- **75 µg Indacaterol (LB) + Placebo (PoS)** (EXPERIMENTAL) — 75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
- **75 µg Indacaterol (PoS) + Placebo (LB)** (EXPERIMENTAL) — 75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
- **37.5 µg Indacaterol (PoS) + Placebo (LB)** (EXPERIMENTAL) — 37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
- **Placebo (LB) and Placebo (PoS)** (EXPERIMENTAL) — Placebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.

## Interventions

- **75 µg indacaterol maleate (LB)** (DRUG) — 75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
- **75 µg indacaterol maleate (PoS)** (DRUG) — 75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
- **37.5 µg indacaterol maleate (PoS)** (DRUG) — 37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
- **placebo to indacaterol (LB)** (DRUG) — Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
- **placebo to indacaterol (PoS)** (DRUG) — Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.

## Primary Outcomes

- **Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment** _(time frame: Day 8)_ — Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.

## Secondary Outcomes

- **Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment** _(time frame: Day 2)_
- **Peak FEV1 at Day 1 and Day 7** _(time frame: Day 1, Day 7)_
- **Time to Peak FEV1 at Day 1 and Day 7** _(time frame: Day 1, Day 7)_
- **FEV1 at Each Time-Point on Day 1 and Day 2** _(time frame: Day 1, Day 2)_
- **FEV1 at Each Time-Point on Day 7 and Day 8** _(time frame: Day 7, Day 8)_
- **Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2** _(time frame: Day 1, Day 2)_
- **Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8** _(time frame: Day 7, Day 8)_
- **FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2** _(time frame: Day1, Day 2)_
- **FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8** _(time frame: Day 7, Day 8)_
- **Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2** _(time frame: Day 1, Day 2)_
- **Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8** _(time frame: Day 7, Day 8)_
- **Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)** _(time frame: Day 1, Day 7)_
- **Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)** _(time frame: Day 1, Day 7)_
- **Peak Expiratory Flow Rate in the Morning in the Evening** _(time frame: Up to 101 days)_
- **Number of Puffs of Rescue Medicine** _(time frame: Up to 101 days)_
- **Number of Participants With Adverse Events as a Measure of Safety** _(time frame: Up to 101 days)_
- **Time to Reach Maximum Concentration (Tmax) After Drug Administration** _(time frame: Day1, Day 7)_
- **Observed Maximum Concentration (Cmax) After Drug Administration** _(time frame: Day 1, Day 7)_
- **Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)** _(time frame: Day 1, Day 7)_

## Locations (2)

- Novartis Investigative Site, Wiesbaden, Germany, Germany
- Novartis Investigative Site, Machester, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.novartis investigative site|wiesbaden|germany|germany` — added _(2026-05-12)_
- `locations.novartis investigative site|machester||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01484197.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01484197*  
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