NCT02173691

Brief Summary

The objective of this study is to compare the long-term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo inpatients with COPD.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
584

participants targeted

Target at P75+ for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2000

Completed
14.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

1.2 years

First QC Date

June 20, 2014

Last Update Submit

June 25, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

  • Trough forced expiratory volume in one second (FEV1) response

    6 months

  • Transition Dyspnoea Index (TDI) focal score

    6 months

Secondary Outcomes (22)

  • Average FEV1 response

    30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24

  • Peak FEV1 response

    30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24

  • Trough FVC (forced vital capacity) response

    30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24

  • Average FVC (forced vital capacity) response

    30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24

  • Peak FVC (forced vital capacity) response

    30 and 60 min prior to and 30 and 60 min, 2 and 3 h post treatment on day 1, week 2, 8, 16, 24

  • +17 more secondary outcomes

Study Arms (3)

Tiotropium

EXPERIMENTAL
Drug: Tiotropium inhalation powder capsulesDrug: Placebo inhalation aerosol

Salmeterol

ACTIVE COMPARATOR
Drug: Salmeterol inhalation aerosolDrug: Placebo inhalation powder capsules

Placebo

PLACEBO COMPARATOR
Drug: Placebo inhalation aerosolDrug: Placebo inhalation powder capsules

Interventions

Tiotropium inhalation powder capsulesDRUG
Tiotropium
Salmeterol inhalation aerosolDRUG
Salmeterol
Placebo inhalation aerosolDRUG
PlaceboTiotropium
Placebo inhalation powder capsulesDRUG
PlaceboSalmeterol

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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 Metered Dose Inhaler (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 diary card records.
  • Ability to give written informed consent in accordance with Good Clinical Practice and local regulations.

You may not qualify if:

  • Clinically significant diseases other than COPD.
  • 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.
  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2014

First Posted

June 25, 2014

Study Start

February 1, 1999

Primary Completion

May 1, 2000

Last Updated

June 26, 2014

Record last verified: 2014-06