SPIRIVA in Ususal Care

NCT00274079 | Completed Phase 4

• 1 other identifier: 205.276
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 44

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in one second (FEV1) response determined at the end of the 12- week treatment period

  week 12

Secondary Outcomes (8)

• Trough FEV1 response after 2 and 6 weeks

  week 2, week 6

• Trough Forced Vital Capacity (FVC) response after 2, 6 and 12 weeks

  week 2, week 6, week 12

• Dyspnoea measured by the Oxygen Cost Diagram (OCD

  week 12

• Weekly mean number per day of occasions when Short Acting β2 Agonist (SABA) therapy was used

  week 12

• Percentage compliance with study medication as assessed by inhalation capsule counts

  week 12

Interventions

SPIRIVA DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

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 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (44)

Foresterhill Healthcentre

Aberdeen, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Airdrie, ML6 0JU, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Atherstone, CV9 1EU, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Barry, CF63 4HP, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Bath, BA1 2SR, United Kingdom

Location

The Beehive Surgery, Bath

Bath, BA2 1NH, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Bath, BA2 4BY, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Bedworth, CV6 4DD, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Bellshill, ML4 1DQ, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Bexhill-on-Sea, TN39 5JB, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Bexhill-on-Sea, TN40 1JJ, United Kingdom

Location

Health Centre

Biggar, ML12 6BE, United Kingdom

Location

Bradford Health Centre

Bradford Upon Avon, BA15 1DQ, United Kingdom

Location

Pembroke Road Surgery

Bristol, BS8 3EU, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Cardiff, CF4 4UJ, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Chapelhall, ML6 8SR, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Coatbridge, ML5 3AP, United Kingdom

Location

Coatbridge Health Centre

Coatbridge, ML5 3AP, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Corsham, SN13 8NA, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Corsham, SN13 9DL, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Coventry, CV5 6EU, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Doncaster, DN1 2EG, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Garston, WD, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Glasgow, G3 8YJ, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Glasgow, G41 3YA, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Glasgow, G44 3DH, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Glasgow, G46 8NY, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Glenboig, ML5 2RY, United Kingdom

Location

Princess Street Surgery

Gorseinon, SA4 4US, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Hamilton, ML3 0NQ, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Haverfordwest, SA61 1RN, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Heywood, OL10 4NH, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Holt, NR25 6BH, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Kingswood, BS15 2NJ, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Leicester, LE3 9ED, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Melksham, SN12 6UN, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Plymouth, PL6 6HP, United Kingdom

Location

St Chads Surgery

Radstock, BA3 2UH, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Royal Leamington Spa, CV32 4RA, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Rutherglen, G73 2PQ, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Sheffield, S3 9DA, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Soham, CB7 5JD, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Wishaw, ML2 7BQ, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Woking, United Kingdom

Location

Related Publications (1)

• Freeman D, Lee A, Price D. Efficacy and safety of tiotropium in COPD patients in primary care--the SPiRiva Usual CarE (SPRUCE) study. Respir Res. 2007 Jul 2;8(1):45. doi: 10.1186/1465-9921-8-45.

  PMID: 17605774 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

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

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim Ltd./Bracknell

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2006
• First Posted: January 10, 2006
• Study Start: October 1, 2002
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

GB (44)