SPIRIVA in Ususal Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00274079
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : November 1, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:

The objective of the study is to determine the effect on lung function when either SPIRIVA once daily or placebo once daily is added to the usual therapy (care) of COPD patients naïve to anticholinergic agents managed in primary care. Previous studies have been in both hospital in and outpatients, with washout of some respiratory medications, this is the first study to be conducted in General Practice, the drug's anticipated environment.

Data from this study, including the adverse event monitoring, and post study findings on physical examination, will be used to extend the safety database. Health Resource Utilisation (HRU) data will be recorded to be use with data from other sources for economic analysis of COPD treatment.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: SPIRIVA Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel Group, 12 Week Study, Comparing the Effect of Once Daily Tiotropium Lactose Capsule With Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD), naïve to Anticholinergic Agents in Addition to Receiving Their Usual COPD Care
Study Start Date : October 2002
Actual Primary Completion Date : October 2003
Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Primary Outcome Measures :
  1. Trough Forced Expiratory Volume in one second (FEV1) response determined at the end of the 12- week treatment period [ Time Frame: week 12 ]

Secondary Outcome Measures :
  1. Trough FEV1 response after 2 and 6 weeks [ Time Frame: week 2, week 6 ]
  2. Trough Forced Vital Capacity (FVC) response after 2, 6 and 12 weeks [ Time Frame: week 2, week 6, week 12 ]
  3. Dyspnoea measured by the Oxygen Cost Diagram (OCD [ Time Frame: week 12 ]
  4. Weekly mean number per day of occasions when Short Acting β2 Agonist (SABA) therapy was used [ Time Frame: week 12 ]
  5. Percentage compliance with study medication as assessed by inhalation capsule counts [ Time Frame: week 12 ]
  6. Adverse events [ Time Frame: week 12 ]
  7. Seated pulse rate and blood pressure [ Time Frame: week 12 ]
  8. Physical examination [ Time Frame: week 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Prior to participation in the study all patients must sign and date an informed consent consistent with ICH-GCP guidelines.
  • Male or female patients 40 years of age or older.
  • Patients with a diagnosis of COPD according to BTS criteria..A stable disease state with airway obstruction of FEV1 between 30- 65% of predicted normal value and FEV1 /FVC<70% pre bronchodilators.
  • Predicted normal values will be calculated according to ECCS:
  • For height measured in metres

    • Males: FEV1 predicted (L) = 4.30 X (Ht in mts) - 0.029 X (Age in yrs) - 2.49
    • Females:FEV1 predicted (L) = 3.95 X (Ht in mts) - 0.025 X (Age in yrs) - 2.60
  • For height measured in inches

    • Males: FEV1 predicted (L) = 4.30 X (Ht in inches/39.37) - 0.029 X (Age in yrs) - 2.49
    • Females:FEV1 predicted (L) = 3.95 X (Ht in inches/39.37) - 0.025 X (Age in yrs) - 2.60
  • Maintained on a stable respiratory medication for 4 weeks prior to visit 1 (no changes in respiratory medication oral dosage).
  • Currently taking salbutamol or terbutaline MDI or DPI.
  • Patient must be able to inhale medication through the HandiHaler?
  • Patients must be able to perform technically acceptable pulmonary function tests in accordance with ATS criteria and must be able to maintain records (Patient Daily Record) during the study period as required in the protocol.
  • Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
  • Pack Years = Number of cigarettes/day 20 (Patients who have never smoked cigarettes must be excluded.)

NOTE: An exacerbation of COPD requiring treatment occurring within the four week period prior to screening visit 1 will mean that screening should be postponed for at least four weeks. Therefore, the patient should have duration of at least 4 weeks free of exacerbations.

Exclusion Criteria:

  • 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 who have taken inhaled anticholinergics in the previous 12 months. Patients that have been treated with inhaled anticholinergics (via nebuliser or metered dose inhaler) due to an exacerbation for a time period no longer than 7 days may be included.
  • Patients with an upper respiratory tract infection or exacerbation of COPD requiring treatment in the four weeks prior to the screening visit (visit 1) or during the two-week run-in period.

Patients with a recent history (i.e., six months or less) of myocardial infarction.

  • Any unstable or life threatening cardiac arrhythmia requiring intervention or a change in drug therapy within the last year.
  • Patients with known active tuberculosis.
  • Patients who have a history of thoracotomy with pulmonary resection or have planned lung transplantation or lung volume reduction surgery.
  • Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
  • Patients who are being treated with antihistamines (H1 receptor antagonists) for asthma or excluded allergic conditions.
  • Patients with a history of cancer in the last five years; Basal cell tumours or patients whose length of time in remission is greater than five years can be included.
  • Patient with known hypersensitivity to atropine, and other anticholinergic drugs or lactose or any previous adverse reaction to anticholinergic drugs that resulted in withdrawal of the anticholinergic compound.
  • Patients using oral corticosteroid medication at unstable doses (i.e. Patients have been on a stable dose for less than 6 weeks prior to randomisation) or at doses in excess of the equivalent of 10mg o

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00274079

United Kingdom
Foresterhill Healthcentre
Aberdeen, United Kingdom
Boehringer Ingelheim Investigational Site
Airdrie, United Kingdom, ML6 0JU
Boehringer Ingelheim Investigational Site
Atherstone, United Kingdom, CV9 1EU
Boehringer Ingelheim Investigational Site
Barry, United Kingdom, CF63 4HP
Boehringer Ingelheim Investigational Site
Bath, United Kingdom, BA1 2SR
The Beehive Surgery, Bath
Bath, United Kingdom, BA2 1NH
Boehringer Ingelheim Investigational Site
Bath, United Kingdom, BA2 4BY
Boehringer Ingelheim Investigational Site
Bedworth, United Kingdom, CV6 4DD
Boehringer Ingelheim Investigational Site
Bellshill, United Kingdom, ML4 1DQ
Boehringer Ingelheim Investigational Site
Bexhill-on-Sea, United Kingdom, TN40 1JJ
Boehringer Ingelheim Investigational Site
Bexhill, United Kingdom, TN39 5JB
Health Centre
Biggar, United Kingdom, ML12 6BE
Bradford Health Centre
Bradford Upon Avon, United Kingdom, BA15 1DQ
Pembroke Road Surgery
Bristol, United Kingdom, BS8 3EU
Boehringer Ingelheim Investigational Site
Cardiff, United Kingdom, CF4 4UJ
Boehringer Ingelheim Investigational Site
Chapelhall, United Kingdom, ML6 8SR
Boehringer Ingelheim Investigational Site
Coatbridge, United Kingdom, ML5 3AP
Coatbridge Health Centre
Coatbridge, United Kingdom, ML5 3AP
Boehringer Ingelheim Investigational Site
Corsham, United Kingdom, SN13 8NA
Boehringer Ingelheim Investigational Site
Corsham, United Kingdom, SN13 9DL
Boehringer Ingelheim Investigational Site
Coventry, United Kingdom, CV5 6EU
Boehringer Ingelheim Investigational Site
Doncaster, United Kingdom, DN1 2EG
Boehringer Ingelheim Investigational Site
Garston, United Kingdom, WD
Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom, G3 8YJ
Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom, G41 3YA
Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom, G44 3DH
Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom, G46 8NY
Boehringer Ingelheim Investigational Site
Glenboig, United Kingdom, ML5 2RY
Princess Street Surgery
Gorseinon, United Kingdom, SA4 4US
Boehringer Ingelheim Investigational Site
Hamilton, United Kingdom, ML3 0NQ
Boehringer Ingelheim Investigational Site
Haverfordwest, United Kingdom, SA61 1RN
Boehringer Ingelheim Investigational Site
Heywood, United Kingdom, OL10 4NH
Boehringer Ingelheim Investigational Site
Holt, United Kingdom, NR25 6BH
Boehringer Ingelheim Investigational Site
Kingswood, United Kingdom, BS15 2NJ
Boehringer Ingelheim Investigational Site
Leamington Spa, United Kingdom, CV32 4RA
Boehringer Ingelheim Investigational Site
Leicester, United Kingdom, LE3 9ED
Boehringer Ingelheim Investigational Site
Melksham, United Kingdom, SN12 6UN
Boehringer Ingelheim Investigational Site
Plymouth, United Kingdom, PL6 6HP
St Chads Surgery
Radstock, United Kingdom, BA3 2UH
Boehringer Ingelheim Investigational Site
Rutherglen, United Kingdom, G73 2PQ
Boehringer Ingelheim Investigational Site
Sheffield, United Kingdom, S3 9DA
Boehringer Ingelheim Investigational Site
Soham, United Kingdom, CB7 5JD
Boehringer Ingelheim Investigational Site
Wishaw, United Kingdom, ML2 7BQ
Boehringer Ingelheim Investigational Site
Woking, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Ltd./Bracknell

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00274079     History of Changes
Other Study ID Numbers: 205.276
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action