---
title: Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity
nct_id: NCT00999908
overall_status: COMPLETED
phase: PHASE3
sponsor: Novartis Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Chronic Obstructive Pulmonary Disease
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00999908.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00999908"
ct_last_update_post_date: 2016-02-17
last_seen_at: "2026-05-12T06:00:53.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

**Official Title:** Multicenter, Randomized, Blinded, Placebo-controlled, Crossover, Single-dose Study to Assess the Effect of Indacaterol (150 μg) Versus Tiotropium (18 μg) on Inspiratory Capacity in Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients

**NCT ID:** [NCT00999908](https://clinicaltrials.gov/study/NCT00999908)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 54
- **Lead Sponsor:** Novartis Pharmaceuticals
- **Conditions:** Chronic Obstructive Pulmonary Disease
- **Start Date:** 2009-10
- **Completion Date:** 2010-03
- **CT.gov Last Update:** 2016-02-17

## Brief Summary

This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.

## Eligibility

- **Minimum age:** 40 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:

  1. Smoking history of at least 10 pack-years.
  2. Forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 50% of the predicted normal value.
  3. Post-bronchodilator FEV1/Force vital capacity (FVC) \< 0.7.

Exclusion Criteria:

* Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening.
* Patients who have had a respiratory tract infection within 6 weeks prior to screening.
* Patients with concomitant pulmonary disease.
* Patients with alpha-1-antitrypsin deficiency.
* Patients with contraindications for tiotropium treatment.
* Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes.

Other protocol-defined inclusion/exclusion criteria applied to the study.
```

## Arms

- **Indacaterol 150 μg-tiotropium 18 μg-placebo** (EXPERIMENTAL) — Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
- **Tiotropium 18 μg-placebo-indacaterol 150 μg** (EXPERIMENTAL) — Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
- **Placebo-indacaterol 150 μg-tiotropium 18 μg** (EXPERIMENTAL) — Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.

## Interventions

- **Indacaterol 150 μg** (DRUG) — Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
- **Tiotropium 18 μg** (DRUG) — Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
- **Placebo** (DRUG) — Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

## Primary Outcomes

- **Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment** _(time frame: 4 hour period following inhalation of study treatment)_ — During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.

## Secondary Outcomes

- **Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment** _(time frame: 4 hour period following inhalation of study treatment)_
- **Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment** _(time frame: 4 hour period following inhalation of study treatment)_

## Locations (11)

- Novartis Investigative Site, Bergamo, Italy
- Novartis Investigative Site, Brescia, Italy
- Novartis Investigative Site, Cava de' Tirreni, Italy
- Novartis Investigative Site, Genova, Italy
- Novartis Investigative Site, Milan, Italy
- Novartis Investigative Site, Orbassano, Italy
- Novartis Investigative Site, Pavia, Italy
- Novartis Investigative Site, Reggio Emilia, Italy
- Novartis Investigative Site, Sesto San Giovanni, Italy
- Novartis Investigative Site, Treviso, Italy
- Novartis Investigative Site, Verona, Italy

## Recent Field Changes (last 30 days)

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- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
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- `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)_
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- `outcomes.primary` — added _(2026-05-12)_
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- `armsInterventions.arms` — added _(2026-05-12)_
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- `sponsor.lead` — added _(2026-05-12)_
- `locations.novartis investigative site|bergamo||italy` — added _(2026-05-12)_
- `locations.novartis investigative site|brescia||italy` — added _(2026-05-12)_
- `locations.novartis investigative site|cava de' tirreni||italy` — added _(2026-05-12)_
- `locations.novartis investigative site|genova||italy` — added _(2026-05-12)_
- `locations.novartis investigative site|milan||italy` — added _(2026-05-12)_
- `locations.novartis investigative site|orbassano||italy` — added _(2026-05-12)_
- `locations.novartis investigative site|pavia||italy` — added _(2026-05-12)_
- `locations.novartis investigative site|reggio emilia||italy` — added _(2026-05-12)_
- `locations.novartis investigative site|sesto san giovanni||italy` — added _(2026-05-12)_
- `locations.novartis investigative site|treviso||italy` — added _(2026-05-12)_
- `locations.novartis investigative site|verona||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00999908.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00999908*  
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