Free Combinations of Tiotropium Inhalation Powder Capsule + Salmeterol Metered Dose Inhaler, Tiotropium Inhalation Powder Capsule and Salmeterol Metered Dose Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02242253 | Completed Phase 2

• 1 other identifier: 1184.7
• Study Type: interventional
• Target: 97
• Locations: 0 countries
• Sites: N/A

Brief Summary

Main Study: To evaluate and to compare the lung function response to the free combinations of tiotropium 18 μg (QD) + salmeterol 50 μg (QD or BID), salmeterol 50 μg BID and tiotropium 18 μg QD at the end of 6-week treatment periods in patients with COPD. Sub-Study: Was performed in subset of patients participating in the Main Study to assess the effect of the four randomised treatments on dynamic hyperinflation. Extension Study: To establish whether the FEV1 time profile following combination bronchodilator therapy of tiotropium plus salmeterol is affected by the pharmaceutical formulation of salmeterol, i.e. the MDI or the Diskus®.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Area under the curve of forced expiratory volume in one second (FEV1 AUC0-24h)

  up to 12 hours after morning and evening dose

• FEV1 AUC0-12h

  up to 12 hours after morning and evening dose

Secondary Outcomes (14)

• FEV1 AUC12-24h

  after 6 weeks of each treatment

• AUC of forced vital capacity (FVC AUC0-12h)

  after 6 weeks of each treatment

• FVC AUC0-24h

  after 6 weeks of each treatment

• FVC AUC12-24h

  after 6 weeks of each treatment

• Peak FEV1

  after 6 weeks of each treatment

Study Arms (4)

Tiotropium+salmeterol QD

EXPERIMENTAL

free combination of tiotropium and salmeterol

Drug: Tiotropium; Drug: Salmeterol; Drug: Placebo-MDI

Tiotropium+salmeterol BID

ACTIVE COMPARATOR

free combination of tiotropium and salmeterol

Drug: Tiotropium; Drug: Salmeterol; Drug: Placebo-MDI

Tiotropium QD

ACTIVE COMPARATOR

Drug: Tiotropium; Drug: Placebo-MDI

Salmeterol BID

ACTIVE COMPARATOR

Drug: Salmeterol; Drug: Placebo HandiHaler®

Interventions

Tiotropium DRUG

administered via HandiHaler®

Tiotropium QD; Tiotropium+salmeterol BID; Tiotropium+salmeterol QD

Salmeterol DRUG

administered via metered dose inhaler (MDI)

Salmeterol BID; Tiotropium+salmeterol BID; Tiotropium+salmeterol QD

Placebo-MDI DRUG

Tiotropium QD; Tiotropium+salmeterol BID; Tiotropium+salmeterol QD

Placebo HandiHaler® DRUG

Salmeterol BID

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions
• All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
• Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 ≤ 60% of predicted normal and FEV1 ≤ 70% of FVC (Visits 1 and 2)
• Male or female patients 40 years of age or older
• Patients must be current or ex-smokers with a smoking history of more than 10 pack-years (Patients who had never smoked cigarettes have to be excluded)
• Patients must be able to perform technically acceptable pulmonary function tests and must be able to maintain records (Patient Daily Diary Card) during the study period as required in the protocol
• Patients must be able to inhale medication in a competent manner from the HandiHaler® device and from a metered dose inhaler (MDI)

You may not qualify if:

• Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
• Patients with a recent history (i.e. six months or less) of myocardial infarction
• Patients with any unstable or life-threatening cardiac arrhythmia or patients who have been hospitalised for such an event within the past year
• Patients with a malignancy for which the patient has undergone resection, Radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed
• Patients with known narrow-angle glaucoma
• Patients with a history of asthma, allergic rhinitis or who have a total blood eosinophil count ≥600 mm3
• Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
• Patients with known active tuberculosis
• Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1)
• Patients who regularly use daytime oxygen therapy
• Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
• Patients who are being treated with oral beta-adrenergics
• Patients who are being treated with cromolyn sodium or nedocromil sodium
• Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
• Patients with known hypersensitivity to anticholinergic drugs, beta-adrenergics, lactose or any other components of the medication delivery systems

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Study Start: September 1, 2003
• Primary Completion: July 1, 2004
• Last Updated: September 17, 2014

Record last verified: 2014-09