Tiotropium/Salmeterol Inhalation Powder in COPD

Boehringer Ingelheim

Status and phase: Terminated; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Tiotropium; Drug: Placebo; Drug: Tiotropium/Salmeterol; Drug: Tiotropium/Salmeterol QD + Salmeterol; Drug: Salmeterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00668772

2007-005107-17 (EudraCT Number)

1184.15

Details and patient eligibility

About

The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined bt the SGRQ and the effect on COPD exacerbations

Enrollment: 207 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Main:

Diagnosis of COPD Post-bronchodilator FEV1<80% predicted and FEV1/FVC<70% predicted

Exclusion criteria

Main:

Significant other diseases then COPD Recent MI Any unstable or life-threatening cardiac arrythmia requiring intervention or change in drug therapy during the past year Hospitalisation for cardiac failure during the past year History of asthma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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207 participants in 5 patient groups, including a placebo group

Tiotropium/Salmeterol QD

Experimental group

Description:

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Treatment:

Drug: Tiotropium/Salmeterol

Tiotropium QD

Active Comparator group

Description:

Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Treatment:

Drug: Tiotropium

Salmeterol BID

Active Comparator group

Description:

Salmeterol Inhalation Powder, hard PE capsule

Treatment:

Drug: Salmeterol

Tiotropium/Salmeterol QD + Salmeterol

Active Comparator group

Description:

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule

Treatment:

Drug: Tiotropium/Salmeterol QD + Salmeterol

Placebo

Placebo Comparator group

Description:

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Treatment:

Drug: Placebo