SPIRIVA in Ususal Care

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274079
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: SPIRIVA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Trough Forced Expiratory Volume in one second (FEV1) response determined at the end of the 12- week treatment period [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trough FEV1 response after 2 and 6 weeks [ Time Frame: week 2, week 6 ] [ Designated as safety issue: No ]
  • Trough Forced Vital Capacity (FVC) response after 2, 6 and 12 weeks [ Time Frame: week 2, week 6, week 12 ] [ Designated as safety issue: No ]
  • Dyspnoea measured by the Oxygen Cost Diagram (OCD [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Weekly mean number per day of occasions when Short Acting β2 Agonist (SABA) therapy was used [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Percentage compliance with study medication as assessed by inhalation capsule counts [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Seated pulse rate and blood pressure [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • Physical examination [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 395
Study Start Date: October 2002
Estimated Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274079

Locations
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
Boehringer Ingelheim Investigational Site
Bath, United Kingdom, BA2 4BY
The Beehive Surgery, Bath
Bath, United Kingdom, BA2 1NH
Boehringer Ingelheim Investigational Site
Bedworth, United Kingdom, CV6 4DD
Boehringer Ingelheim Investigational Site
Bellshill, United Kingdom, ML4 1DQ
Boehringer Ingelheim Investigational Site
Bexhill, United Kingdom, TN39 5JB
Boehringer Ingelheim Investigational Site
Bexhill-on-Sea, United Kingdom, TN40 1JJ
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
Coatbridge Health Centre
Coatbridge, United Kingdom, ML5 3AP
Boehringer Ingelheim Investigational Site
Coatbridge, United Kingdom, ML5 3AP
Boehringer Ingelheim Investigational Site
Corsham, United Kingdom, SN13 9DL
Boehringer Ingelheim Investigational Site
Corsham, United Kingdom, SN13 8NA
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, G46 8NY
Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom, G41 3YA
Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom, G3 8YJ
Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom, G44 3DH
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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Ltd./Bracknell
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00274079     History of Changes
Other Study ID Numbers: 205.276
Study First Received: January 9, 2006
Last Updated: October 31, 2013
Health Authority: United Kingdom: Medicines Control Agency

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

ClinicalTrials.gov processed this record on August 28, 2014