Multiple Dose Comparison of Tiotropium Inhalation Capsules, Salmeterol Inhalation Aerosol and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02172287 | Completed Phase 3

• 1 other identifier: 205.130
• Study Type: interventional
• Target: 623
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the long -term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo in patients with COPD. A secondary objective of this study was to compare the impact of tiotropium and salmeterol on humanistic and economic health outcomes, such as quality of life, patient preference and Health Resource Utilisation in this patient population.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Change from baseline in trough Forced expiratory volume in one second (FEV1) response

  baseline, up to day 169

• Change from baseline in Mahler Transitional Dyspnoea Index (TDI)

  baseline, up to day 169

Secondary Outcomes (22)

• Average Forced Expiratory Volume (FEV1) response on each test-day

  60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169

• Peak Forced Expiratory Volume (FEV1) response on each test-day

  60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169

• Trough Forced Vital Capacity (FVC) on each test day

  60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169

• Average Forced Vital Capacity (FVC) on each test day

  60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169

• Peak of Forced Vital Capacity (FVC) on each test day

  60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169

Study Arms (3)

Tiotropium (Ba679 BR)

EXPERIMENTAL

Tiotropium capsule once daily by oral inhalation

Drug: Tiotropium (Ba679 BR); Drug: Placebo (for Salmeterol)

Salmeterol

ACTIVE COMPARATOR

Salmeterol inhalation aerosol twice daily

Drug: Salmeterol; Drug: Placebo (for Tiotropium )

Placebo

PLACEBO COMPARATOR

* Tiotropium (Ba679 BR)- placebo one capsule once daily by inhalation * Salmeterol- placebo, inhalation aerosol twice daily

Drug: Placebo (for Tiotropium ); Drug: Placebo (for Salmeterol)

Interventions

Tiotropium (Ba679 BR) DRUG

One capsule once daily by oral inhalation

Tiotropium (Ba679 BR)

Salmeterol DRUG

Inhalation aerosol twice daily

Salmeterol

Placebo (for Tiotropium ) DRUG

Placebo for Tiotropium delivered by inhalation capsule

Placebo; Salmeterol

Placebo (for Salmeterol) DRUG

Placebo for Salmeterol delivered by inhalation aerosol

Placebo; Tiotropium (Ba679 BR)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 40 years.
• A diagnosis of relatively stable, moderate to severe COPD with:
• Screening FEV1 ≤ 60% of predicted normal value (calculated according to European Community for Coal and Steel (ECCS criteria R94- R1408) and screening FEV1 ⁄ FVC ≤ 70%).
• Smoking history ≥ 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent).
• Ability to be trained in the proper use of the HandiHaler® device and Mahler Dyspnoea Index (MDI).
• Ability to perform all study related tests including the Shuttle Walking Test, acceptable pulmonary function tests, including Peak Expiratory Flow Rate (PEFR) measurements, and maintenance of daily diary card records.
• Ability to give written informed consent in accordance with Good Clinical Practice (GCP) and local regulations.

You may not qualify if:

• Clinically significant diseases other than COPD. A clinically significant disease is defined as one 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.
• All patients with a serum glutamic oxaloacetic transaminase (SGOT) \> 80 IU/L, serum glutamic pyruvic transaminase (SGPT) \> 80 IU/L, bilirubin \> 2.0 mg/dL or creatinine \> 2.0 mg/dL will be excluded regardless of clinical condition. Repeat laboratory evaluation should have not been conducted in these patients.
• A recent history (i.e., one year or less) of myocardial infarction.
• Any cardiac arrhythmia requiring drug therapy or hospitalisation for heart failure within the past three years.
• Inability to abstain from regular daytime use of oxygen therapy for more than 1 hour per day.
• Known active tuberculosis.
• History of cancer within the last five years (excluding basal cell carcinoma).
• History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
• Patients who have undergone thoracotomy with pulmonary resection.
• Any upper respiratory infection in the past six weeks prior to the screening visit or during the run-in period.
• Current participation in a pulmonary rehabilitation programme or completion of a pulmonary rehabilitation programme in the six week prior to the screening visit.
• Known hypersensitivity to anticholinergic drugs, salmeterol, or any of the components of the lactose powder capsule or MDI delivery systems.
• Known symptomatic prostatic hypertrophy or bladder neck obstruction.
• Patients with known narrow-angle glaucoma.
• Current treatment with cromolyn sodium or nedocromil sodium.

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: February 1, 1999
• Primary Completion: May 1, 2000
• Last Updated: June 24, 2014

Record last verified: 2014-06